Clinical UM Guideline

This document addresses the following treatments for urinary incontinence:

• Adjustable balloon system implantation
• Artificial urinary sphincter devices
• Endovaginal cryogen-cooled, monopolar radiofrequency remodeling
• Injection of periurethral bulking agents
• Intraurethral valve-pump implantation
• Transurethral radiofrequency energy collagen micro-remodeling
• Transvaginal radiofrequency bladder neck suspension 
• Vaginal weight training

Note: This document does not address either of the following types of devices:

• Pessaries (removable prosthetic devices inserted into the vagina)
• Urinary incontinence devices approved for use without a prescription (for example, the Flyte system)

Note: Please see the following related documents for additional information:

• CG-MED-97 Biofeedback and Neurofeedback
• CG-SURG-95 Sacral Nerve Stimulation for Urinary Retention, Urinary Incontinence, and Fecal Incontinence
• CG-SURG-126 Tibial Nerve Stimulation

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

Medically Necessary:

Injection of periurethral bulking agents is considered medically necessary when the individual has stress urinary incontinence (SUI) meeting one the following two criteria (A or B):

1. The incontinence is due to trauma or injury; or
2. Both of the following are true (1 and 2):
   1. The incontinence persists despite conservative treatment for at least a sufficient duration to fully assess treatment effect*; and
   2. One of the following is true:
      1. The incontinence is caused by intrinsic sphincter deficiency (ISD), or
      2. The incontinence is due to urethral hypermobility in individuals with abdominal leak point less than 100 cm H₂O.

Repeat injection of periurethral bulking agents is considered medically necessary for individuals who meet the medical necessity criteria for initial injection and have persistent incontinence after the initial injection.

Implantation of an artificial urinary sphincter device is considered medically necessary in adults following prostate surgery to treat urinary incontinence due to reduced outlet resistance (Intrinsic Sphincter Deficiency [ISD]) when the symptoms of incontinence persist despite conservative treatment for at least a sufficient duration to fully assess treatment effect.*

Removal of an artificial urinary sphincter device is considered medically necessary for individuals who meet one of the following criteria:

1. The individual is no longer obtaining continued benefit derived from use of the device; or
2. There is a need to repair or replace the device; or
3. The individual has a medical indication for device removal.

Repair of an artificial urinary sphincter device is considered medically necessary for individuals who meet both of the following criteria:

1. The device experienced mechanical failure; and
2. The individual is likely to obtain continued benefit from use of the device.

Implantation of a replacement artificial urinary sphincter device is considered medically necessary for individuals who meet the following criteria:

1. An artificial urinary sphincter device was removed; and
2. The individual continues to meet criteria for implantation of an artificial urinary sphincter device.

*Note: The time frame for prior conservative treatment measures (for example, exercises, medication, behavioral therapy) to demonstrate a refractory response is at least 2 months duration, subject to individual variability.

Not Medically Necessary:

Injection of periurethral bulking agents is considered not medically necessary for individuals who do not meet the medically necessary criteria.

Implantation, reimplantation, removal, or repair of an artificial urinary sphincter device are considered not medically necessary for individuals who do not meet the medically necessary criteria.

The following services are considered not medically necessary as treatments for urinary incontinence:

1. Endovaginal cryogen-cooled, monopolar radiofrequency remodeling;
2. inFlow^™ intraurethral valve-pump implantation;
3. ProACT^™ adjustable continence therapy;
4. Transurethral radiofrequency energy collagen micro-remodeling;
5. Transvaginal radiofrequency bladder neck suspension;
6. Vaginal weight training with specially designed weights (cones).

This document describes clinical studies and expert recommendations, and explains when certain treatments for urinary incontinence (involuntary leakage of urine) are clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Urinary incontinence, commonly referred to as leakage of urine, is a common problem and there are many proposed treatment methods available to treat the cause and symptoms of the condition. The options include bulking agents injected around the urethra (the tube that carries urine from the bladder out of the body), an artificial urinary sphincter (AUS) device, vaginal weight training, radiofrequency treatments, an adjustable balloon system, and a valve-pump placed in the urethra. These treatments do not all work the same way. Some aim to support the urethra. Some try to improve muscle control. Some use a device to help stop leakage. Each option has possible benefits and harms.

What the Studies Show

Periurethral bulking agents are materials injected around the urethra to help reduce urine leakage. Studies in females with stress urinary incontinence (SUI) show that these injections can improve symptoms for some people and usually have a good safety profile. Still, they often work less well than surgery, and repeat injections are common. Reported harms include urinary tract infection, temporary urinary retention, and the need for more treatment later.

An AUS is an implanted device that helps close the urethra and reduce leakage. Studies in adults after prostate surgery show that this device can improve the control of urination for many people, and some become dry or nearly dry. But complications are important, and may include infection, damage to nearby tissue, mechanical failure, pain, and more surgery to repair, revise, or remove the device.

For vaginal weight training, radiofrequency treatments, the ProACT (Uromedica, Inc. Plymouth, MN) adjustable balloon system, the inFlow (Vesiflo, Inc., Medfield, MA) valve-pump, and other proposed treatments, the studies are limited, mixed, or not compared with the best standard treatments. Better studies are needed to know if these options improve health.

Periurethral bulking agents

• These injections place a material around the urethra to help reduce SUI.
• Studies show modest improvement for some people, but cure rates are lower than with some surgeries.
• Repeat injections may be needed because the effect may lessen over time.
• Reported harms include urinary tract infection, temporary trouble emptying the bladder, and the need for more treatment.

Artificial urinary sphincter device

• This is an implanted device that helps close the urethra and can reduce urine leakage.
• Studies in adults after prostate surgery show that many people improve, and some become dry.
• The device may work for years, but reoperation is common in some studies.
• Reported harms include infection, wearing away of surrounding tissue, device failure, and another surgery to repair, replace, or remove the device.

Vaginal weight training

• This uses small vaginal weights during pelvic floor exercises.
• Studies did not clearly show better symptom relief than pelvic floor exercises alone.
• Some people may improve muscle strength, but symptom improvement was not clearly better.
• Better studies are needed to know whether this improves health

Transvaginal radiofrequency bladder neck suspension

• This treatment uses radiofrequency energy during a vaginal procedure to tighten tissue near the bladder neck.
• The studies did not compare to other treatments, so we cannot tell how well the treatment works compared with other care.
• Some people improved in these studies, but comparison studies are missing.
• Better studies are needed to know whether this improves health.
• Possible harms of a surgical procedure can include pain, bleeding, infection, and more treatment later.

Transurethral radiofrequency collagen micro-remodeling

• This treatment applies heat inside the urinary tract to change tissue and try to reduce leakage.
• One trial had mixed results. A pressure measure improved, but quality-of-life improvement was not clearly better than after fake treatment.
• Long-term studies had large losses to follow-up, which makes the results less certain.
• Better studies are needed to know whether this improves health.

inFlow intraurethral valve-pump

• This device sits in the urethra and uses a pump to help empty the bladder.
• Studies showed that some females who could tolerate the device had better quality of life.
• Many people stopped using it early because of discomfort, leakage, or trouble using it.
• Better studies are needed to know whether this improves health for urinary incontinence, and the balance of benefit and harm is unclear.

ProACT adjustable continence therapy

• This is an implanted balloon system that can be adjusted after placement to help control leakage.
• Studies showed improvement in some males after prostate surgery, but results were inconsistent.
• Complications and repeat procedures were common, including movement, wearing away of surrounding tissue, failure, and removal.
• Better studies are needed to know whether this improves health, and the risk of harm may outweigh the benefit for some people.

Endovaginal cryogen-cooled, monopolar radiofrequency remodeling

• This treatment uses a vaginal probe to deliver cooled radiofrequency energy.
• Early studies suggested possible improvement in some females, but the studies were small and lacked strong comparison groups.
• Long-term benefit and safety remain unclear.
• Better studies are needed to know whether this improves health.

When is this Clinically Appropriate?

Based on the Position Statement, the following may be considered clinically appropriate:

When is this Not Clinically Appropriate?

The following have not been proven to improve health and are not considered clinically appropriate:

• Endovaginal cryogen-cooled, monopolar radiofrequency remodeling. The studies were small and did not provide strong comparison data.
• inFlow intraurethral valve-pump implantation. The available studies had high dropout rates and limited evidence for use in urinary incontinence.
• ProACT adjustable continence therapy. Studies found frequent complications and repeat procedures, and the main U.S. study did not meet its main effectiveness goal.
• Transurethral radiofrequency energy collagen micro-remodeling. Study results were mixed, and better studies are needed to know if this improves health.
• Transvaginal radiofrequency bladder neck suspension. The evidence came mainly from studies without comparison groups, so it is not known whether this is as good as other treatments.
• Vaginal weight training with specially designed weights, also called cones. Studies did not clearly show better symptom improvement than pelvic floor exercises alone.

These treatments are not clinically appropriate because the studies do not clearly show that they improve health enough to outweigh the risks. Possible harms include discomfort, infection, urinary problems, device failure, erosion, or the need for more procedures.

Urinary incontinence treatments are not clinically appropriate in scenarios other than those listed above.

(Return to Description)

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Injection of Periurethral Bulking Agents
When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for all other diagnoses.

Artificial Urinary Sphincter
When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met, for all other diagnoses.

Other procedures and devices
When services are Not Medically Necessary:

Summary

This document addresses surgical and minimally invasive treatments for urinary incontinence (UI), with a primary focus on stress urinary incontinence (SUI) that persists despite conservative therapy or is related to intrinsic sphincter deficiency (ISD). Evidence shows that periurethral bulking agents are associated with modest improvement and a favorable safety profile, although durability may be limited and repeat treatments are often required. Artificial urinary sphincters (AUS’s) are associated with higher rates of continence in observational studies, but the evidence for them is primarily non-randomized, and their use carries higher rates of complications and reintervention. Other interventions, including radiofrequency-based therapies, adjustable balloon systems, and intraurethral devices, are supported by limited or inconsistent evidence often derived from small, uncontrolled studies with variable follow-up, which limits conclusions regarding effectiveness and long-term outcomes. Clinical practice guidelines from organizations such as the American Urological Association (AUA), Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU), Society of Genitourinary Reconstructive Surgeons (GURS), and American Urogynecologic Society (AUGS) support a stepwise, individualized approach to management. These guidelines recognize bulking agents and sphincter devices as options for appropriately selected individuals, while also noting variability in evidence quality, the potential need for repeat or revision procedures, and the importance of considering individual factors such as severity of incontinence, prior treatments, and ability to use implanted devices.

Discussion

Urinary voiding dysfunction includes UI which is the inability to hold urine in the bladder and urinary retention, which is the inability to pass urine out of the bladder. Both males and females can experience urinary voiding dysfunction. Many females experience some UI due to pregnancy and childbirth, menopause, and the structure of the female urinary tract. Urinary retention in females can be caused by bladder muscle failure or obstruction. Many males experience incontinence and retention along with prostate enlargement or after prostate surgery.

There are a variety of therapies used to treat UI. The least invasive approaches include behavioral techniques such as fluid management and bladder training, pelvic floor muscle exercises and scheduled toilet trips. Medications used to treat urinary incontinence include anticholinergics or beta-3 adrenergic agonists such as mirabegron. In addition, the following medical devices are potential treatment options:

Periurethral bulking agents refer to a variety of materials (collagen, carbon coated beads, calcium hydroxylapatite or polydimethylsiloxane) that may be injected around the urethra to provide better bladder control.

Vaginal weight training uses small, specially designed weights ("cones") that can be placed in the vagina and held there to strengthen the muscles in the pelvic area. Over time, increasingly heavier weights are used and this is thought to increase muscle strength. The vaginal cones are made from surgical grade stainless steel surrounded by a double welded plastic case. They are smooth with a plastic-coated retrieval cord.

The SURx Transvaginal System (SURx, Inc., Livermore, California), which obtained U.S. Food and Drug Administration (FDA) clearance in March 2002, was a radiofrequency device that was specifically designed as a transvaginal treatment for SUI. It could be performed as an outpatient procedure under general anesthesia. An incision was made through the vagina lateral to the urethra, exposing the endopelvic fascia. Radiofrequency energy was then applied over the endopelvic fascia in a slow sweeping manner, resulting in blanching and shrinkage of the tissue. As of 2006, the SURx device is no longer marketed in the U.S.

Transurethral radiofrequency energy collagen micro-remodeling was a non-surgical treatment for females with SUI. Radiofrequency energy was used to apply controlled heat to targeted tissues in the lower urinary tract. The heat denatured submucosal collagen in the tissue at the treatment sites. After healing, the tissue was reported to be firmer and have increased resistance to involuntary leakage at times of increased intra-abdominal pressure, thus reducing or eliminating SUI episodes. The Lyrette system (formerly, the Renessa System), originally marketed by Novasys Medical, Inc. (Newark, CA) obtained FDA clearance as substantially equivalent to prior predicate devices and is indicated, “For the transurethral treatment of female SUI due to hypermobility in females who have failed conservative treatment and who are not candidates for surgical therapy” (FDA, 2005). Verathon Medical Ltd acquired the product and rebranded it as Lyrette. In the U.S., Renessa was no longer marketed in 2013 and Lyrette was no longer commercially available as of 2017.

The AUS is an externally controlled urethral occlusion device. The transfer of fluid within the device is controlled by a pressure-regulating balloon placed extraperitoneally in the individual's pelvis or abdominal cavity and a control pump placed in a subcutaneous pocket in the scrotum. Squeezing of the pump allows fluid within the closed-loop system to be transferred from the cuff to the balloon. It takes a few minutes before the cuff re-inflates automatically to the preset level, allowing the urethra to remain open for voiding. The valve then automatically re-tightens several minutes later which closes the urethra, thereby enabling control of urine flow and continence to be achieved. In 2001, the AMS Sphincter 800^™ Urinary Control System, obtained clearance from the FDA to treat urinary incontinence due to reduced outlet resistance following prostate surgery. The AUS is contraindicated for individuals with repeated urinary infections; urethral diverticula at the expected implant site; in complex, unstable, or recurrent urethral stricture disease; in small capacity and/or non-compliant bladder prior to definitive treatment; in irreversibly obstructed urinary tracts; in irresolvable detrusor hyperreflexia or bladder instability; or in those who lack the physical and/or mental dexterity to manipulate the pump.

The inFlow intraurethral valve-pump and activator is a urinary device for females with incomplete bladder emptying, due to impaired detrusor contractility (IDC). The inFlow is promoted as an alternative to urinary catheters. The device consists of a small catheter with an internal, magnetically activated pump-valve mechanism which is placed in the female urethra for up to 29 days or less. Upon activation by a battery-powered wand held low over the pubic area, the valve opens and the pump induces urine flow. The device blocks urine flow when continence is desired, and an internal pump draws urine out of the bladder when activated by the user. Proper device sizing and initial insertion is done by a physician. Subsequent device replacements are self-inserted, or inserted by a caregiver, approximately every 29 days. This device obtained FDA clearance through the de novo approval process in 2014 and is indicated for, “Use in female individuals 18 years of age or older who have incomplete bladder emptying, due to IDC of neurologic origin, and who are capable of operating it in accordance with instructions or who have trained caregivers” (FDA, 2014).

The ProACT system consists of two postoperatively adjustable silicone balloons placed under fluoroscopic guidance at the prostatic apex (in post-transurethral resection of the prostate [TURP] procedures), or at the vesico-urethral anastomosis (in post prostatectomy procedures) in males. Balloon titration is achieved via tubing connected to a titanium port in the scrotum to enable post-implantation adjustments. The balloons are filled with isotonic solution following implantation; 1 ml can be titrated monthly until optimum continence is achieved.

The Viveve (Viveve Medical, Inc., Englewood CA) treatment of SUI involved placement of a probe into the vagina that emitted cryogen-cooled radiofrequency energy. The intention was for the cryogen cooling to protect the tissue from damage while the radiofrequency energy delivered energy into the tissue to remodel collagen and improve the structural integrity of the vagina, including support of the urethra. The Viveve device received FDA clearance “for use in general surgical procedures for electrocoagulation and hemostasis” (FDA, 2020). It is not currently cleared specifically for treatment of UI. Viveve Medical Inc. filed for bankruptcy (Chapter 11) in 2023, and its operations were effectively wound down. As a result, the Viveve cryogen-cooled monopolar radiofrequency system is not currently being produced or commercially promoted in the U.S.

Periurethral Bulking Agents

Periurethral injections of bulking agents, such as cross-linked collagen, carbon-coated beads (for example, Durasphere^™ Carbon Medical Technologies, St. Paul, MN), calcium hydroxylapatite (for example, Coaptite^® Merz North America, Inc., Raleigh, NC) and polydimethylsiloxane (for example, Macroplastique^® Laborie Medical Technologies Corp., Portsmouth, NH, Minneapolis, MN) and non-particulate homogenous gel (for example, Bulkamid^®, Contura International A/S, Seborg, Denmark), have been studied in randomized controlled trials (RCTs). These trials have established the safety and efficacy of agents cleared by the U.S. Food and Drug Administration (FDA) for the treatment of adult females with SUI due to ISD.

A 2017 Cochrane systematic review by Kirchin and colleagues was limited to RCTs evaluating bulking agents to treat UI in females who reported at least one objective outcome measure such as pad weight reduction. A total of 14 RCTs met eligibility requirements, with sample sizes ranging from 30 to 355. Comparison interventions included placebo (1 trial), pelvic floor exercises (1 trial) other surgical techniques (2 trials), a different bulking agent (8 trials) and different injection sites using the same agent (2 trials). Due to differences in study design, the investigators did not pool study findings. The authors noted that data up to 12 months suggests that injection of bulking agents appear to be less effective but safer than open surgery.

Several systematic reviews evaluating bulking agents have included both controlled and uncontrolled observational studies (Capobianco, 2020; Hoe, 2021; Pivazyan, 2022; Siddiqui, 2017). A 2020 systematic review by Capobianco and colleagues included 21 studies, 1 of which was an RCT, on bulking agents to treat SUI or mixed UI. The pooled improvement rate in studies with at least 1 year of follow-up was 57% (95% confidence interval [CI], 39% to 74%). The pooled cure rate after at least 1 year of follow-up was 21% (95% CI, 16% to 27%). In a pooled analysis of 5 studies that reported objective measures and had at least 1 year of follow-up, the objective treatment success rate was 46% (95% CI, 37% to 55%).

Pivazyan and colleagues (2022) focused on studies comparing bulking agents with surgical procedures in females with SUI. They identified six eligible studies, three RCTs and three controlled non-randomized studies. A pooled analysis of data from these six studies found significantly greater subjective improvement in symptoms in the surgery group compared with the bulking agents group (p=0.01). A pooled analysis of three studies did not find a statistically significant difference in complications after surgery or after injection of bulking agents (p=0.73). Other systematic reviews listed above (Hoe, 2021; Siddiqui, 2017) did not pool study findings.

A 2022 systematic review by Braga and colleagues included 11 uncontrolled studies on use of bulking agents after the failure of a mid-urethral sling. The pooled cure or improvement rate was 75%, the pooled failure rate was 35% and the pooled reoperation rate was 25%. The authors noted a high degree of statistical heterogeneity among studies but they did not identify publication bias. A limitation of the systematic review is that the authors did not differentiate between the cure rate and the improvement rate. Further limitations include the absence of RCTs or control groups and reliance on mostly retrospective observational studies with small and heterogeneous samples.

An uncontrolled study (Zivanovic, 2017) reported both a combined cure or improvement rate after urethral bulking following midurethral sling failure, as well as each outcome separately. The cure rate was 56.7% after 1 month, 43.3% after 6 months and 25.4% after 12 months. The improvement rate was 38.3% after 1 month, 46.7% after 6 months and 58.2% after 12 months. The combined cure or improvement rates were 93.3% at 1 month, 88.3% at 6 months and 83.6% after 12 months.

A non-randomized comparative study by Gaddi and colleagues (2014) examined outcomes after either urethral bulking or repeat midurethral sling following primary midurethral sling failure. The study included 165 individuals with midurethral sling failure; 98 received another sling and 67 received urethral bulking. A total of 11 of 98 (11.2%) individuals in the repeat slings group experienced treatment failure compared with 26 of 65 (38.8%) individuals in the bulking agents group. The rate of failure was significantly higher in the bulking agent group, p=0.004.

The 2023 update of a joint guideline by the AUA/SUFU recommended bulking agents as one of several options for individuals considering surgery for SUI (Strong Recommendation; Evidence Level: Grade A). The guideline does not address bulking agents after midurethral sling failure (Kobashi, 2023).

A guideline from AUGS (Fleischmann 2024) recommended bulking agents for treatment of “demonstrable SUI”. The guideline also included the following recommendation:

Patients should be counseled on the risks, lack of long-term efficacy data, potential need for repeat injections, possible need for additional treatment for recurrent SUI, implications for future procedures, and pelvic imaging findings that may be seen after UBA. Strong recommendation based on grade B aggregate evidence for treatment effect, with a preponderance of benefit over harm

Regarding the possible need for repeat injections, the guideline stated:

Due to heterogenous study populations, diverse methodology, and follow-up periods, there is significant variability in the need for repeat injections or “top-ups” between studies. Top-up rates for all UBAs range from 10% to more than 67%, regardless of product type.

In a retrospective review, Abdulraheem (2025) evaluated the short-term effectiveness of polyacrylamide hydrogel (Bulkamid) transurethral injection as a primary or salvage treatment for females with SUI or mixed UI. In this single-center retrospective cohort, 97 evaluable individuals (mean age 62 years) underwent office-based periurethral injections and were assessed approximately 30 days after treatment using satisfaction scores reported by those individuals. Overall mean satisfaction was 61.8%, with significantly higher satisfaction among individuals treated as a secondary (salvage) procedure (69.7%) compared with those treated primarily (53.7%). The procedure was performed under local anesthesia and no immediate or delayed complications were reported during the short follow-up period, suggesting that polyacrylamide hydrogel may be a safe and minimally invasive option for managing SUI, including in individuals who have failed prior anti-incontinence procedures such as mid-urethral slings or Burch colposuspension.

Ghoniem (2025) reported the 5-year results of the ROSE study, a prospective multicenter observational trial evaluating the long-term safety and efficacy of a polydimethylsiloxane-based urethral bulking agent (UBA) (Macroplastique) for females with SUI due to ISD. The study enrolled 274 individuals across 22 U.S. centers, with follow-up assessments conducted at 3 months and annually for 5 years using Stamey grade, Incontinence Quality of Life (I-QOL) scores, and Patient Global Impression of Satisfaction (PGI-S). Among the 147 participants who completed the 5-year follow-up, 47.6% demonstrated improvement in SUI severity and 21.8% achieved complete dryness. Quality-of-life scores improved substantially from a mean of approximately 45 at baseline to 70.9 at 5 years, and about 63.5% of individuals reported being satisfied with treatment outcomes. The safety profile was favorable, with one device-related serious adverse event (urinary retention) that resolved and mostly minor adverse events such as urinary tract infection (30.8%) and transient urinary retention (7.2%), typically occurring early and resolving with conservative management. These findings suggest that this bulking agent provides durable symptom improvement and sustained quality-of-life benefits over a 5-year period for appropriately selected individuals with SUI.

Vaginal Weight Training

Vaginal weight training is a behavioral therapy that involves placing small weights (also called cones) in the vagina while performing Kegel exercises. Kegel exercises are repeated tightening and relaxing of the pelvic floor muscles, the muscles that support the bladder, uterus, and bowel, to help improve strength and control. The use of vaginal weights has not been shown to improve pelvic floor muscle strength more than Kegel exercises alone. A 2013 Cochrane review by Herbison and Dean identified 23 RCTs comparing weighted vaginal cones to a control treatment in females with urinary incontinence. The authors noted that all the studies had small sample sizes, some had high drop-out rates and study quality was difficult to assess in many cases. Most studies used a similar protocol in which individuals held the cones in place twice a day for 15 minutes. Outcome measures varied widely. Of interest are studies that compare the efficacy of vaginal cones plus pelvic floor muscle training (PFMT) to the efficacy of PFMT alone. Two trials addressed this comparison and neither found a significant benefit from the addition of vaginal cones. There were 13 trials that compared vaginal cones and PFMT. In a pooled analysis of 4 trials, there was not a significant between groups difference in leakage episodes per day (mean difference [MD], 0.00; 95% CI, -0.20 to 0.20). Similarly, a pooled analysis of 5 trials did not find a significant between groups difference in the proportion of individuals with improvement on the pad test (risk ratio [RR], 1.10; 95% CI, 0.82 to 1.49). The ability to conduct pooled analyses was limited by variability in control interventions and outcome measures and thus a relatively small number of studies were included in the meta-analyses. In these meta-analyses, objective measures did not find a significant benefit of vaginal cones compared with PFMT.

In a small prospective study, Haddad and colleagues (2011) evaluated vaginal cone therapy in a passive phase (without voluntary contractions of the pelvic floor) and an active phase (with voluntary contractions). Of the 24females with SUI who were treated, 21 completed the 3-month study. Outcomes in the pad test favored the active phase as did pelvic floor evaluation and bladder neck mobility. Complete reversal of symptoms was observed in 12 (57.1%) participants, and satisfaction was expressed by 19 (90.4%). This study lacked a comparison group of females who did pelvic floor exercises without the use of vaginal cones.

Bar Chen (2025) conducted a pilot RCT to evaluate the effectiveness of extracorporeal vaginal Peflex weights as an adjunct to PFMT for females with SU. There were 35 females aged 18-50 with SUI who were randomized to either PFMT with Peflex weights or standard PFMT without weights for 6 weeks. Both groups demonstrated significant within-group improvements in SUI symptoms as measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI-SF) with no significant difference between groups in the primary outcome, indicating similar symptom reduction with or without the device (p>0.05). The Peflex group showed significantly greater improvements in pelvic floor muscle power (p=0.015), repetitions of contraction (p=0.007), and ultrasound-measured levator hiatus contraction (p=0.022) compared with the control group, suggesting enhanced muscle performance. However, no significant difference between groups was observed in the ICIQ-UI-SF, the primary outcome of interest (p=0.660), indicating that symptom reduction was similar with or without the device. Participants using Peflex weights also reported high satisfaction and no adverse effects. These findings suggest that Peflex weights may improve pelvic floor muscle strength and endurance while providing a safe, non-surgical adjunct to conventional pelvic floor training, but without improvement in incontinence symptoms. Interpretation of this study’s findings is limited by the small sample size, short 6-week follow-up, lack of assessor blinding, and outcome measurements performed in the supine position. As a pilot study, these results are preliminary, and larger randomized trials with longer follow-up are needed to determine whether the observed improvements in muscle function translate into meaningful clinical benefit.

Transvaginal Radiofrequency Bladder Neck Suspension (SURx Transvaginal System^®)

Several uncontrolled studies have evaluated the use of transvaginal radiofrequency bladder neck suspension. Dmochowski and colleagues (2003) reported on a prospective case series of 120 consecutive females with SUI treated with transvaginal bladder neck suspension. Enrolled participants had failed at least a 3-month trial of conservative therapy, most commonly including pelvic floor muscle exercises or pelvic floor stimulation. Follow-up examinations at 1, 3, 6 and 12 months consisted of a history, physical examination and urodynamic studies. In addition, each participant completed a voiding diary and quality of life questionnaire. A cure was defined as a negative Valsalva maneuver; improvement was defined as decreased daily episodes or pad use. A total of 73% of the participants were considered cured or improved at 12 months. More than 68% of the participants reported satisfaction with the treatment. The study is limited by the lack of a comparison group.

Transurethral Radiofrequency Energy Collagen Micro-Remodeling (Lyrette™, formerly Renessa^® System)

A 2015 Cochrane review by Kang and colleagues identified a single RCT evaluating transurethral radiofrequency energy collagen micro-remodeling for treatment of SUI. This trial, by Appell and colleagues (2006), randomized 173 females with SUI to active (n=110) or sham (n=63) treatment and followed participants for 12 months. Primary outcomes were leak point pressure (LPP and score on the I-QOL. At 12 months, 136 of 173 participants (79%) were available for analysis of LPP. Individuals in the active treatment group had an increase in mean LPP of 13.2 cm H₂O and those in the sham group had a decrease in mean LPP of 2 cm H₂O. The difference in LPP between groups was statistically significant (p=0.002). A total of 142 participants (82%) provided data for the I-QOL outcome at 12 months. The proportion of evaluable participants with at least a 10 point I-QOL improvement (considered clinically meaningful) was 48% in the active treatment arm and 44% in the sham arm. The difference between groups did not differ significantly (p=0.70). The study had mixed findings and was limited by a substantial drop-out rate and the uncertain clinical significance of the LPP measure.

In addition to the RCT, a prospective, single-arm study with 3 years of follow-up evaluated transurethral collagen denaturation (Renessa, now Lyrette, Verathon, Inc., Bothell, WA) in females with SUI caused by bladder outlet hypermobility (Elser, 2011). Objective measures included voiding diaries and in-office stress pad weight tests. Subjective measures included the I-QOL, Urogenital Distress Inventory (UDI-6), and Patient Global Impression of Improvement (PGI-I) instruments. Of the 136 females who were treated, 75 (55%) were available for 12-month follow-up (Elser, 2009). At 12 months, significant reductions existed from baseline in the median number of daily (-0.61) and weekly (-4.0) leaks caused by activity, and 50% of the participants experienced at least 50% fewer leaks compared with baseline (52% of evaluable participants). At the 18-month follow-up (Elser, 2010), data were available for 60 participants (44%). The study found incontinent episodes decreased whereas quality of life and participant satisfaction with the procedure increased.

A total of 41 females (30%) completed the 3-year follow-up. According to diary data available for 39 participants, 24 (62%) reported at least a 50% reduction in leaks per day. The investigators also reported an intention-to-treat (ITT) analysis of data from all 136 participants (last observation carried forward), 46.7% reported at least a 50% reduction in leaks from baseline. Based on the ITT analysis with multiple imputations of missing data, 60% of the participants had at least a 50% reduction in leaks. This study was limited by significant attrition and a lack of a control or comparison group.

Additional data from clinical trials with appropriate control groups and more complete follow up is needed to support conclusions about the effects of transurethral radiofrequency energy collagen micro-remodeling for treatment of SUI.

Artificial Urinary Sphincter (AUS) Devices

Observational studies have evaluated use of AUS devices in adults with refractory UI due to ISD following prostate surgery (Boswell, 2020; Dosanjh, 2020; Sacomani, 2018; Tutolo, 2019). No RCTs were identified. A large multicenter retrospective cohort study was published by Tutolo and colleagues in 2019. The study included 892 cases of AUS implantation in males with non-neurogenic SUI after prostate surgery who were followed for at least 1 year. The mean length of follow-up was 32 months (range 12 to 300 months). The primary outcome was the dry rate (DR) which was defined as not needing to use any pads. Data on pad use prior to surgery were available for 547 of the 892 participants (61%). All 547 individuals used at least 1 pad per day prior to treatment, including 368 (67%) who used at least 5 pads. At follow-up, the DR was 58% for the cohort. Among individuals without previous incontinence surgery, 409 of 724 (57%) were dry at follow-up, and the DR was 48% in individuals with previous incontinence surgery (80 of 168). The overall complication rate was 28% (248 individuals). Reported complications included erosion, infection, urethral atrophy and mechanical failure.

A study by Sacomani and colleagues (2018) reported long-term outcomes in 121 consecutive males who underwent AUS implantation following prostatectomy. After a mean follow-up of 5.2 years, 106 (88%) still had their AUS device and 82 of these (68%) reported being completely dry. Investigators have noted high complication rates (for example, infection, erosion, mechanical failure and device explantation) and the need for reoperative procedures in up to 20% of implanted individuals (Imamoglu, 2005; Kim, 2008). For these reasons, AUS is not considered a first-line therapy and is reserved for those who have not responded to conventional treatment options for at least 6 months following prostate surgery.

Boswell (2020) focused on long-term device survival and reintervention rates. The study included 1154 males who underwent AUS placement for SUI following radical prostatectomy or other prostate procedure. Participants were followed for a mean of 5.4 years. The rate of secondary surgery (removal or revision) was 35% (404 of 1154). According to Kaplan-Meier survival analysis, estimates of rates of device survival were 72% at 5 years, 56% at 10 years, 41% at 15 years and 33% at 20 years.

In a systematic review of studies of males with post-prostatectomy incontinence who were treated with an AUS or an adjustable sling (Guachetá Bomba, 2019), the authors identified seven studies with a total of 463 participants, 420 of whom had SUI following prostatectomy. In the studies, 313 received an AUS and 107 received an adjustable sling. There were no RCTs and no head-to-head comparisons of AUS and adjustable slings. The primary outcome of the review was decreased pad use. The analysis for this outcome included three studies on each intervention. Compared with no intervention, pad use decreased with either intervention and there was no statistically significant difference between interventions.

Zhang and Xu (2022) published a meta-analysis of studies on the impact of radiation therapy on outcomes of AUS placement. The review included studies with at least 25 participants that compared outcomes of AUS in individuals with or without a history of radiation therapy. A total of 18 studies met eligibility criteria; all were cohort studies. In a pooled analysis, individuals without radiation therapy had significantly higher odds of an absence of incontinence after AUS compared with individuals treated with radiation therapy (odds ratio [OR], 0.35; 95% CI, 0.21 to 0.59; p<0.0001). There was also a significant increase in the risk of revision surgery (OR, 1.74; 95% CI, 1.16 to 2.60; p=0.07) and a slight increased risk of infections (OR, 2.51; 95% CI, 1.00 to 6.29; p=0.05) for the individuals with a history of radiation therapy. Also, the odds of explantation were significantly higher in the prior radiation group (OR, 3.00; 95% CI, 1.16 to 7.75; p=0.02). The authors did not report other efficacy outcomes such as improvement in urinary incontinence or pad use. The odds of mechanical failure did not differ significantly between groups. The authors concluded that radiotherapy appears to worsen functional outcomes and increases several complication risks after AUS, even in more contemporary studies. Limitations include the fact that all included studies were observational (mostly retrospective cohorts) with moderate risk of bias, substantial clinical and methodological heterogeneity (differences in UI cause and severity, prostate treatments, radiotherapy timing and dose, AUS technique, follow-up, and outcome definitions) and failure to control for potentially confounding comorbid conditions.

Mamane and colleagues (2022) published a multicenter cohort study with a relatively large sample size. The study included 1277 males who had an AUS and over 1 year of follow-up. Of these, 437 (34%) had a history of radiotherapy. Mean length of follow-up was 36.8 months. Rates of social continence at follow-up were 78.8% in the group with prior radiotherapy and 78.2% in the group without radiotherapy (p=0.84). The primary study outcome, explantation-free survival, was significantly lower in the radiotherapy group than the non-radiotherapy group (p=0.001). Revision-free survival, however, was significantly higher in the radiotherapy group (p=0.02). Nonmechanical failure-free survival was somewhat higher in the radiotherapy group, but the difference between groups was not statistically significant (p=0.077). In multivariate analysis, history of pelvic radiation therapy, age, Charlson score (a measure of co-morbidities) and previous pelvic surgery were independently associated with revision-free survival. This study provides large-scale observational evidence suggesting that prior pelvic radiation is associated with increased device-related complications and reduced device survival following AUS implantation. However, methodological limitations including its retrospective design, lack of standardization, and incomplete adjustment for key confounders limit causal inference, and the impact on continence appears minimal.

A systematic review (Barakat, 2020) of published literature on AUS for females with SUI identified 15 uncontrolled retrospective and prospective studies with a mean of 68 individuals per study. The authors rated the quality of evidence as very low due to a high risk of bias in all the included studies as well as publication bias and “serious imprecision.” In a meta-analysis, the authors noted a high degree of heterogeneity in the post-operative continence rate and found a median continence rate of 79%. They also found a revision rate of 15%. Despite the high rate of post-operative continence, the review found limitations such as small study populations, and that published meta-analyses were of retrospective cohorts. The author reported that there was a “relatively high need for revision surgery” and more prospective studies are needed.

An uncontrolled retrospective study reported results for 45 females over 75 years of age with SUI due to ISD who had AUS implantation (Denormandie, 2021). During surgery, bladder dome injuries occurred in 9 individuals (20%) and vaginal injuries occurred in 3 (6.7%). There were 26 early postoperative complications in 18 individuals (40%). All except 1 were minor complications. Median follow-up was 36 months. Late postoperative complications occurred in 7 individuals (15.5%). There were 5 individuals who died for reasons unrelated to the surgery and did not complete follow-up. At the final follow-up, 32 of the 45 individuals (71%) had their original AUS, 2 had had their AUS explanted, 9 had AUS revisions and 2 had AUS deactivations. In an ITT analysis, 31 of the 45 study participants (69%) had total continence at last follow-up.

In 2024, Roth and colleagues published a retrospective review of 136 individuals who had AUS implantation for SUI post-prostatectomy. There were 108 primary implantations and 28 revision implantations. In the primary implantation group at follow-up (median 80 months), 49.1% reported complete dryness and 85.2% were socially continent but 20.4% experienced early (≤ 30 day) complications and 27.8% required reoperation, most commonly due to cuff erosion. Overall, nearly half experienced some adverse event. The 3- and 5-year device survival rates without reoperation for after primary AUS placement were 80% and 76%, respectively. Revision surgery was associated with lower complete dryness rates (32.1%), higher reoperation rates (42.9%), and significantly worse implant survival (3- and 5-year survival 62% and 57%). Diabetes mellitus independently predicted reoperation with a 3.6-fold increased risk, whereas prior radiotherapy did not significantly affect outcomes in this population. The authors concluded that, although an AUS can provide meaningful continence improvement, it carries a substantial complication and reoperation burden, particularly in revision settings.

Canagasingham (2024) provided a targeted literature update of contemporary evidence on the use of the AUS for SUI in females, particularly in cases of ISD or refractory SUI after prior surgical treatments. The review highlights that, although AUS implantation remains relatively uncommon in females compared with males, its use has increased in recent years coinciding with improvements in surgical techniques and minimally invasive approaches. Across studies summarized in the review, continence outcomes are generally favorable, with reported “no-pad” rates ranging from approximately 42% to 86% in heterogenous populations, with one small retrospective cohort reporting approximately 71% long-term continence rates at a median of 7.5 years follow up. Limited observational analyses suggest that device survival and revision rates may be similar, and in some studies more favorable, in females compared to males. Emerging robotic or minimally invasive implantation techniques may reduce mechanical failure and reconstructive surgery rates compared with open procedures, though they may increase infection risk. The review also discusses surgical approaches (open, laparoscopic, robotic, or transvaginal) and participant selection factors, noting that AUS is typically reserved for complex or severe SUI due to intrinsic sphincter deficiency or refractory cases after prior surgical treatments, particularly when other surgical options are unsuitable. Limitations include the fact that most available studies are retrospective and heterogeneous in design, many include mixed populations (neurogenic and non-neurogenic SUI), and there is a lack of standardized outcome reporting and prospective comparative studies, limiting the ability to clearly define the role of AUS. Overall, while available evidence suggests that AUS can provide meaningful continence improvement in carefully selected individuals, the evidence remains limited by heterogeneity, small study populations, and a predominance of retrospective data, and does not clearly establish its role relative to established surgical alternatives.

Kaufman (2026) reported primary results of the Artificial Urinary Sphincter Clinical Outcomes (AUSCO) trial, a prospective, multicenter, single-arm, international study evaluating the AMS 800 AUS in 115 males with moderate-to-severe SUI due to ISD. Participants underwent AUS implantation across 17 centers and were followed for 12 months using standardized outcome measures including 24-hour pad weight, pad usage, urinary incontinence events, quality-of-life instruments (I-QOL, IIQ-7, EQ-5D-5L), and satisfaction by the individual. The predefined primary endpoint (≥ 50% reduction in pad weight) was met, with 94% of participants achieving this threshold at 12 months, and 60% reporting complete continence (no pad use). Improvements in quality-of-life scores and reductions in incontinence episodes were observed, with 92% reporting satisfaction with the device. Adverse events occurred in 33% of participants, with serious adverse events in 15%. Though device-related serious events occurred in 8.7% and revision surgery was required in 7.8% of cases, most commonly for mechanical malfunction or erosion. Exploratory subgroup analyses (not powered for comparative assessment) suggested that higher body mass index (BMI) (≥ 35) was associated with lower continence improvement and higher serious adverse event rates, while prior radiation therapy and age did not significantly affect outcomes. Limitations include the single-arm design without a comparator group, short follow-up duration, performance at high-volume centers which may limit generalizability, industry funding, and the exploratory nature of subgroup analyses.

A clinical guideline from the AUA, GURS, and SUFU (Breyer, 2024) addressing incontinence after prostate treatment included the following statements on AUS:

• Clinicians should discuss the option of artificial urinary sphincter with patients who are experiencing mild to severe stress urinary incontinence after prostate treatment. (Strong Recommendation; Evidence Level: Grade B)
• Prior to implantation of artificial urinary sphincter, clinicians should ensure that patients have adequate physical and cognitive abilities to operate the device. (Clinical Principle)
• In patients with stress urinary incontinence after primary, adjuvant, or salvage radiotherapy who are seeking surgical management, clinicians should offer artificial urinary sphincter over male slings or adjustable balloons. (Moderate Recommendation; Evidence Level: Grade C)

There were no treatment recommendations on AUS determined to be evidence level Grade A (“well-conducted and highly-generalizable RCTs or exceptionally strong observational studies with consistent findings”).

inFlow Intraurethral Valve-Pump and Activator

The inFlow intraurethral valve-pump received clearance through the FDA’s de novo approval process in 2014. Chen and colleagues (2005) published a multicenter prospective crossover study that evaluated the safety, effectiveness, and individual satisfaction of the intraurethral valve-pump catheter (In-Flow, Vesiflo, Medfield MA) compared with clean intermittent catheterization (CIC) in females with hypocontractile or acontractile bladder. A total of 273 females across 18 centers were enrolled, undergoing an initial CIC baseline phase followed by a treatment phase with the In-Flow device, which is a silicone intraurethral catheter containing a magnetically activated pump operated by an external remote control. Among the 77 individuals who completed the treatment phase, post-void residual volumes were comparable between In-Flow and CIC (20.3 mL vs. 16.1 mL), while quality of life improved significantly with a mean increase in I-QOL score of 25.9 points (p<0.001). Rates of urinary tract infection were similar or slightly lower during device use. However, the study reported substantial early withdrawal, with 169 of 273 (61.9%) participants discontinuing, most commonly due to urethral discomfort or leakage, highlighting tolerability issues with the device. Limitations include the high attrition rate, lack of a randomized control design (single-arm crossover), potential selection bias due to the tolerability screening phase, and limited long-term outcome data, which restrict the generalizability of the findings. Controlled trials are needed to enable conclusions to be drawn about the effectiveness of the inFlow intraurethral pump compared to more established treatments.

Hartigan (2022) reported on the available peer-reviewed literature on the inFlow intraurethral valve-pump, a nonsurgical device designed to assist bladder emptying in females with detrusor underactivity (DUA), a condition that often results in chronic UI and typically requires catheter-based bladder drainage. The inFlow device is a self-retaining intraurethral catheter equipped with a magnetically driven pump that is activated by a handheld remote, allowing individuals to empty the bladder in a manner that mimics normal voiding and potentially improving independence and quality of life. Across seven clinical studies, including a pivotal multicenter crossover trial, the device demonstrated bladder emptying comparable to CIC with low post-void residual volumes and generally low rates of urinary tract infection. For individuals who tolerated the device, quality of life improved substantially, and many preferred the device over catheterization. However, approximately half of individuals discontinued use early, most commonly due to discomfort, leakage, or difficulty operating the device. The review suggested that the inFlow system may provide a meaningful alternative to catheterization for selected individuals who cannot perform or do not tolerate CIC. Limitations of the evidence include the small number of studies, relatively small sample sizes, high early dropout rates, heterogeneous populations, and limited contemporary data, as most studies were conducted years before publication of this review. Additionally, the article is a narrative literature review relying on previously published studies rather than a systematic methodology, which introduces potential selection bias and limits the strength of conclusions regarding long-term safety and comparative effectiveness.

ProACT Adjustable Continence Therapy

The ProACT System is an implantable, volume-adjustable balloon device connected by bi-lumen tubing to a subcutaneous injection port. The ProACT system was approved by the FDA in November 2015 via a premarket approval (PMA) application for treatment of males with stress incontinence of at least 12 months’ duration following prostate surgery who did not respond to conservative therapy. 

FDA clearance was based on results of a prospective, multi-center, single-arm, open-label clinical study of 123 individuals in the intent-to-treat cohort. Participants were followed for a minimum of 18 months following implantation with continued follow-up planned. The primary effectiveness endpoint was the average of 2 24-hour pad weight measurements conducted at baseline compared to the average of 2 24-hour pad weight measurements conducted at 18 months. Individual success was defined as ≥ 50% reduction in 24-hour pad weight at 18 months compared to baseline. The prespecified study success criterion required that the lower bound of the exact 95% binomial CI for the responder rate be at least 50%. At 18 months, 46% of participants (57/124) met the individual success definition (95% CI, 37%-55%). Because the lower bound of the CI (37%) fell below the 50% threshold, the study did not meet its primary effectiveness endpoint.

Nash and colleagues (2019) reported 4-year outcomes in 68 of the 123 (55%) individuals who completed follow-up to the study described above. As previously stated, the primary effectiveness outcome was measured at 18 months and efficacy was not established. In the 4-year analysis, 55 of 68 (80.9%) individuals achieved a 50% or greater reduction in 24-hour pad weight. Data was not available for 45% of the original study participants. Of the 68 males included in the analysis, 22 (32%) had at least 1 explant; most of these occurred due to device migration. The time to first explant was 16.4 months. In this cohort, there were 11 procedure-related adverse events in 12 individuals. This included 8 perforations during implant. Significant attrition and lack of a control group limit the applicability of this follow up study’s findings.

Several additional single-arm studies evaluating ProACT in males with SUI following prostate surgery have been published (Bada, 2022; Nestler, 2019; Noordhoff, 2018; Ricard, 2022; Ronzi, 2019). These studies generally reported high rates of complications and the need for revision surgery tended to be high. In the Nestler (2019) study, 59 of 112 implants of the ProACT system (53%) had to be revised after a median of 26 months due to rupture or dislocation/migration. Ronzi and colleagues (2019) identified complications in 70 of 102 cases (69%) including 34 migrations, 18 device failures, 28 urethral erosions and 28 cutaneous erosions. In the Bada (2022) study, 62 individuals underwent ProACT implantation and only 42 of these were included in the analysis. Of these 42 individuals, 8 (19%) required revision or explantation. Ricard (2022) included 200 individuals. Of these, 95 (47.5%) required explantation due to failure or local complications. In addition, 46 individuals (23%) had a second implantation and 11 (5.5%) had a third implantation.

A systematic review of studies on ProACT in males with SUI was published in 2019 by Larson and colleagues. No RCTs were identified. The authors included 19 studies with a total of 1264 individuals. In a pooled analysis of data on ProACT treatment, 60.2% of individuals were dry at follow-up and 81.9% were either dry or improved. No data from any comparison intervention were reported. A pooled analysis of adverse event data from 18 studies found a 5.3% rate of intraoperative bladder or urethra perforation and a 22.2% revision rate over a mean follow-up of 3.6 years.

A systematic review of studies on ProACT in males with SUI identified 18 eligible studies involving a total of 1570 individuals (Tricard, 2023). They were all observational studies; no RCTs were available. The mean continence rate at follow-up (0-1 pads used) in the studies was 55.2%. The mean follow-up time was 34 months. The overall complication rate was 32% with a major complication rate of 11%. Device failure was reported in 11% of cases.

The 2024 AUA/GURS/SUFU clinical guideline on Incontinence after Prostate Treatment (Breyer, 2024) addressed adjustable balloon devices in two recommendations, both of which were determined to have a Grade C evidence level (“RCTs with serious deficiencies of procedure or generalizability or extremely small sample sizes or observational studies that are inconsistent, have small sample sizes, or have other problems that potentially confound interpretation of data”):

• Clinicians may offer adjustable balloon devices to non-radiated patients with mild to severe stress urinary incontinence after prostate treatment. (Conditional Recommendation; Evidence Level: Grade C)
• In patients with stress urinary incontinence after primary, adjuvant, or salvage radiotherapy who are seeking surgical management, clinicians should offer artificial urinary sphincter over male slings or adjustable balloons. (Moderate Recommendation; Evidence Level: Grade C)

Smith (2023) reported results of a literature review regarding contemporary surgical options for SUI in males, including the AUS, urethral slings, and newer devices such as the ProACT adjustable continence therapy system. The ProACT system consists of two adjustable periurethral balloons placed percutaneously near the bladder neck and connected to subcutaneous ports that allow postoperative volume adjustment to optimize continence. Clinical studies demonstrate meaningful improvement in urinary leakage, with reductions in mean daily pad use and 24-hour pad weight. In the U.S. pivotal trial, pad weight decreased substantially and approximately 61% of individuals achieved at least a 50% reduction in leakage at 18 months. A meta-analysis cited in the review reported that daily pad counts decreased from roughly 4 to 1 pad per day, with about 60% of individuals achieving dryness and 82% experiencing at least 50% improvement. Despite these encouraging outcomes, complication and reintervention rates remain notable. Device explantation occurred in about 24% of individuals in early trials, most commonly due to balloon migration. Procedure-related adverse events such as bladder or urethral perforation occurred in roughly 13% of cases. Outcomes may also be worse in individuals with prior pelvic radiation. These individuals have higher risks of urethral erosion. Overall, the ProACT system represents a minimally invasive alternative for males who may not be candidates for an AUS or sling, particularly because it does not rely on manual dexterity for operation. However, limitations include relatively high complication and explant rates, heterogeneous study designs, and a lack of robust long-term durability data compared with more established treatments. This highlights the need for further prospective studies with extended follow-up.

Endovaginal cryogen-cooled, monopolar radiofrequency remodeling

The Viveve system delivers cryogen-cooled, monopolar radiofrequency remodeling endovaginally and is proposed for treatment of SUI in females.

A feasibility RCT published in 2020 by Allan and colleagues included 37 adult females with mild to moderate SUI, defined as 1 to 50 g leakage on a 1-hour pad weight test. Participants had normal pelvic examinations and were not pregnant, recently postpartum, or recently breastfeeding. Individuals were randomized to receive either one or two Viveve cryogen-cooled monopolar radiofrequency treatments. Two participants dropped out of the study. At 12 months, the percentage of participants with at least a 50% reduction in pad weight was similar in the one-treatment (54%) and two-treatment (50%) groups. The cure rate, defined as less than 1g of leakage on the 1-hour pad weight test, was higher in the one-treatment group (75%) than in the two-treatment group (54%). However, no statistical testing was reported, so it is unclear whether these differences are meaningful.

Importantly, both study groups received the active intervention, and there was no sham or untreated comparison group. As a result, the findings do not allow assessment of whether the observed improvements are attributable to the device itself, placebo effects, or the natural course of the condition. The small sample size, participant attrition, and lack of statistical analysis further limit the reliability and generalizability of the results.

Long (2024) investigated the therapeutic effect of monopolar radiofrequency therapy on SUI and sexual function in females. In this prospective study, 34 individuals with mild to moderate SUI underwent a single vaginal radiofrequency treatment using the Viveve system and were evaluated at baseline and 6 months post-treatment using validated symptom questionnaires, urodynamic testing, voiding diaries, and trans-perineal ultrasound measurements. The results demonstrated significant improvements in urinary symptoms and quality-of-life measures. Objective imaging findings supported these clinical outcomes, showing decreased bladder neck mobility, reduced vaginal dimensions, and reduced proximal urethral rotation angle, suggesting enhanced pelvic support. Overall, 76.5% of participants experienced improvement in SUI symptoms at 6 months. Limitations include a small sample size, lack of a control group, and a relatively short follow-up period that limits conclusions regarding long-term durability and safety. Additionally, the single-session treatment design limits assessment of dose-response effects. These factors restrict the generalizability of the findings and highlight the need for larger RCTs with longer follow-up to confirm the efficacy and durability of radiofrequency therapy for SUI.

Overall, evidence for cryogen-cooled monopolar radiofrequency (Viveve) for treatment of stress urinary incontinence in females is insufficient to establish efficacy due to lack of controlled comparative data, small study populations, and methodological limitations.

Artificial urinary sphincter (AUS): A surgically implanted device used to help control urine leakage by keeping the urethra closed until the person is ready to urinate.

Bladder neck: The area where the bladder connects to the urethra.

Bulking agent: Refers to a substance, such as collagen, which is injected near the urethra to help it to remain closed and prevent involuntary loss of urine.

Continence: The ability to control urination and avoid leakage.

Detrusor instability (overactive bladder): Involuntary bladder muscle contractions that can cause a sudden urge to urinate and may lead to incontinence.

Detrusor underactivity: Weak bladder muscle function that makes it hard to empty the bladder completely.

Female: Refers to sex assignment at birth, The gender descriptions used in this document, for example, ‘female’, ‘woman’, and ‘women’, refer to the reproductive capacity of the individual, regardless of gender identity or expression.

Frequency: Needing to urinate more often than usual.

Incontinence Quality of Life (I-QOL): A validated, condition-specific patient-reported outcome measure that assesses the impact of urinary incontinence on daily activities, emotional well-being, and social functioning.

Intrinsic sphincter deficiency (ISD): A poor or non-functioning urethral outlet muscle. ISD can be distinguished from other causes of incontinence with urodynamic studies.

Leak point pressure (LPP): bladder pressure at which urine leakage occurs when there is no bladder contraction (that is, leakage happens because the outlet cannot stay closed, not because the bladder is squeezing).

Male: Refers to sex assignment at birth. The gender descriptions used in this document, for example, ‘male’, ‘man’, and ‘men’, refer to the reproductive capacity of the individual, regardless of gender identity or expression.

Mixed incontinence: A combination of urge and stress incontinence.

Overflow incontinence: A condition in which the bladder overfills without causing a sensation to urinate. Incontinence occurs when the bladder cannot accommodate additional urine produced by the kidneys.

Pad weight test: A test that measures how much urine leaks into a pad over a set period of time.

Pelvic floor muscle training (PFMT): Exercises, often called Kegel exercises, used to strengthen the muscles that support the bladder and urethra.

Periurethral: Around the urethra.

Pessary: A device worn in the vagina to support the pelvic floor as a treatment for pelvic organ prolapse, stress urinary incontinence, or both.

Post-void residual (PVR): The amount of urine left in the bladder after an individual attempts to completely empty the bladder.

Stress urinary incontinence (SUI): The leakage of urine during activities that increase pressure inside the abdomen, such as coughing, sneezing, laughing, lifting, or exercise.

Urethra: The natural channel or tube through which urine passes from the bladder to outside of the body.

Urethral hypermobility: A condition of the urethra in which the bladder and urethra move downwards when abdominal pressure rises. This can be a cause of SUI. Urethral hypermobility is linked to childbirth, especially vaginal deliveries, and risk of the condition increases with multiple births, larger babies and longer labor.

Urgency: A sudden, hard-to-delay need to urinate.

Urinary retention: Inability to empty the bladder completely or at all.

Urinary tract infection (UTI): An infection in any part of the urinary system, usually the bladder.

Urinary urge incontinence: Leakage of urine when there is a strong urge to urinate.

Urodynamic studies: Tests that measure how the bladder and urethra store and release urine.

Peer Reviewed Publications:

1. Abdulraheem E, Attuwaybi A, Lee JY, Eddib A. The efficacy of polyacrylamide hydrogel (Bulkamid) transurethral injection system: the outcome of short-term follow-up of 100 cases. Gynecol Minim Invasive Ther. 2025; 14(3):241-245.
2. Allan BB, Bell S, Husarek K. A 12-month feasibility study to investigate the effectiveness of cryogen-cooled monopolar radiofrequency treatment for female stress urinary incontinence. Can Urol Assoc J. 2020; 14(7):E313-E318.
3. Appell RA, Juma S, Wells WG, et al. Transurethral radiofrequency energy collagen micro-remodeling for the treatment of female stress urinary incontinence. Neurourol Urodyn. 2006; 25(4):331-336.
4. Bada M, Crocetto F, Barone B, et al. ProACT in the management of stress urinary incontinence after radical prostatectomy. What happens after 8 years of follow up? Monocentric analysis in 42 patients. J Basic Clin Physiol Pharmacol. 2022; 34(1):49-54.
5. Bar Chen A, Fligelman T, Kalichman L. A pilot randomized controlled trial of extracorporeal vaginal Peflex weights for enhancing pelvic floor function and relieving stress urinary incontinence. Int J Environ Res Public Health. 2025; 22(11):1703.
6. Barakat B, Franke K, Hijazi S, et al. A systematic review and meta-analysis of clinical and functional outcomes of artificial urinary sphincter implantation in women with stress urinary incontinence. Arab J Urol. 2020; 18(2):78-87.
7. Boswell TC, Elliott DS, Rangel LJ, et al. Long-term device survival and quality of life outcomes following artificial urinary sphincter placement. Transl Androl Urol. 2020; 9(1):56-61.
8. Braga A, Caccia G, Papadia A, et al. Urethral bulking agents for the treatment of recurrent stress urinary incontinence: a systematic review and meta-analysis. Maturitas. 2022; 163:28-37.
9. Canagasingham A, Popa I, Chung A, Tse V. The role of the artificial urinary sphincter in female incontinence in 2023: a literature update. Curr Bladder Dysfunct Rep. 2024; 19:144-149.
10. Capobianco G, Saderi L, Dessole F, et al. Efficacy and effectiveness of bulking agents in the treatment of stress and mixed urinary incontinence: a systematic review and meta-analysis. Maturitas. 2020; 133:13-31.
11. Chen TY, Ponsot Y, Carmel M, et al. Multi-center study of intraurethral valve-pump catheter in women with a hypocontractile or acontractile bladder. Eur Urol. 2005; 48(4):628-633.
12. Denormandie A, Chartier-Kastler E, Haddad R, et al. Long-term functional outcomes of artificial urinary sphincter (AMS 800™) implantation in women aged over 75 years and suffering from stress urinary incontinence caused by intrinsic sphincter deficiency. World J Urol. 2021; 39(10):3897-3902.
13. Dmochowski RR, Avon M, Ross J, et al. Transvaginal radio frequency treatment of the endopelvic fascia: a prospective evaluation for the treatment of genuine stress urinary incontinence. J Urol. 2003; 169(3):1028-1032.
14. Dosanjh A, Baldwin S, Mytton J, et al. A national study of artificial urinary sphincter and male sling implantation after radical prostatectomy in England. BJU Int. 2020; 125(3):467-475.
15. Elser DM, Mitchell GK, Miklos JR, et al. Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 12-month results from a prospective long-term study. J Minim Invasive Gynecol. 2009; 16(1):56-62.
16. Elser DM, Mitchell GK, Miklos JR, et al. Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 18-month results from a prospective long-term study. Neurourol Urodyn. 2010; 29(8):1424-1428.
17. Elser DM, Mitchell GK, Miklos JR, et al. Nonsurgical transurethral radiofrequency collagen denaturation: results at three years after treatment. Adv Urol. 2011; 2011:872057.
18. Gaddi A, Guaderrama N, Bassiouni N, et al. Repeat midurethral sling compared with urethral bulking for recurrent stress urinary incontinence. Obstet Gynecol. 2014; 123(6):1207-1212.
19. Ghoniem G, Lane F, Farhan B, et al. Five-year follow-up study on safety and efficacy of Macroplastique® in female patients with stress urinary incontinence (the ROSE study). Int Urogynecol J. 2025; 36(8):1663-1670.
20. Guachetá Bomba PL, Ocampo Flórez GM, Echeverría García F, et al. Effectiveness of surgical management with an adjustable sling versus an artificial urinary sphincter in patients with severe urinary postprostatectomy incontinence: a systematic review and network meta-analysis. Ther Adv Urol. 2019; 11:1-10.
21. Haddad JM, Ribeiro RM, Bernardo WM, et al. Vaginal cone use in passive and active phases in patients with stress urinary incontinence. Clinics (Sao Paulo). 2011; 66(5):785-791.
22. Hartigan SM, Dmochowski RR. The inFlow intraurethral valve-pump for women with detrusor underactivity: a summary of peer-reviewed literature. J Spinal Cord Med. 2022; 45(4):489-497.
23. Hoe V, Haller B, Yao HH, O’Connell HE. Urethral bulking agents for the treatment of stress urinary incontinence in women: a systematic review. Neurourol Urodyn. 2021; 40(6):1349-1388.
24. Imamoglu MA, Tuygun C, Bakirtas H, et al. The comparison of artificial urinary sphincter implantation and endourethral Macroplastique injection for the treatment of post-prostatectomy incontinence. Eur Urol. 2005; 47(2):209-213.
25. Kaufman MR, Wood HM, Terlecki R, et al. The artificial urinary sphincter clinical outcomes trial: primary results. J Urol. 2026; 215(2):194-202.
26. Kim SP, Sarmast Z, Daignault S, et al. Long-term durability and functional outcomes among patients with artificial urinary sphincters: a 10-year retrospective review from the University of Michigan. J Urol. 2008; 179(5):1912-1916.
27. Larson T, Jhaveri H, Yeung LL. Adjustable continence therapy (ProACT) for the treatment of male stress urinary incontinence: a systematic review and meta-analysis. Neurourol Urodyn. 2019; 38(8):2051-2059.
28. Long CY, Chang CY, Sung IC, et al. The therapeutic effect of monopolar radiofrequency therapy on urinary symptoms and sexual function. Biomedicines. 2024; 12(10):2288.
29. Mamane J, Sanchez S, Lellouch AG, et al. Impact of radiation therapy on artificial urinary sphincter implantation in male patients: a multicenter study. Neurourol Urodyn. 2022; 41(1):332-339.
30. Nash S, Aboseif S, Gilling P, et al. Four-year follow-up on 68 patients with a new post-operatively adjustable long-term implant for post-prostatectomy stress incontinence: ProACT™. Neurourol Urodyn. 2019; 38(1):248-253.
31. Nestler S, Thomas C, Neisius A, et al. Long-term results of ProACT primary and repeat implantation for treatment of stress urinary incontinence in men. World J Urol. 2019; 37(6):1173‐1179.
32. Noordhoff TC, Scheepe JR, Blok BFM. Outcome and complications of adjustable continence therapy (ProACT™) after radical prostatectomy: 10 years' experience in 143 patients. Neurourol Urodyn. 2018; 37(4):1419-1425.
33. Pivazyan L, Kasyan G, Grigoryan B, et al. Effectiveness and safety of bulking agents versus surgical methods in women with stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2022; 33(4):777-787.
34. Ricard H, Léon G, Branchereau J, et al. Adjustable continence balloons in postprostatectomy incontinence: Outcomes and complications. Neurourol Urodyn. 2022; 41(6):1414-1422.
35. Ronzi Y, Le Normand L, Chartier-Kastler E, et al. Neurogenic stress urinary incontinence: is there a place for Adjustable Continence Therapy (ACT™ and ProACT™, Uromedica, Plymouth, MN, USA)? A retrospective multicenter study. Spinal Cord. 2019; 57(5):388‐395.
36. Ross JW, Galen DI, Abbott K, et al. A prospective multisite study of radiofrequency bipolar energy for treatment of genuine stress incontinence. J Am Assoc Gynecol Laparosc. 2002; 9(4):493-499.
37. Roth I, Hjelle KM, Johansen CJ, et al. Primary and revision artificial urinary sphincter for stress urinary incontinence post-radical prostatectomy: a surgery with high rewards but high risks? Scand J Urol. 2024; 59:185-189.
38. Sacomani CAR, Zequi SC, Costa WHD, et al. Long-term results of the implantation of the AMS 800 artificial sphincter for post-prostatectomy incontinence: a single-center experience. Int Braz J Urol. 2018; 44(1):114-120.
39. Siddiqui ZA, Abboudi H, Crawford R, Shah S. Intraurethral bulking agents for the management of female stress urinary incontinence: a systematic review. Int Urogynecol J. 2017; 28(9):1275-1284.
40. Smith WJ, VanDyke ME, Venishetty N, et al. Surgical management of male stress incontinence: techniques, indications, and pearls for success. Res Rep Urol. 2023; 15:217-232.
41. Tricard T, Song QX, Munier P, et al. Adjustable continence therapy (proACT) for the treatment of male stress urinary incontinence post-prostatectomy: a systematic review and meta-analysis (2023 update). World J Urol. 2023; 41(7):1793-1802.
42. Tutolo M, Cornu JN, Bauer RM, et al. Efficacy and safety of artificial urinary sphincter (AUS): results of a large multi-institutional cohort of patients with mid-term follow-up. Neurourol Urodyn. 2019; 38(2):710-718.
43. Zhang L, Xu Y. Impact of radiation therapy on outcomes of artificial urinary sphincter: a systematic review and meta-analysis. Front Surg. 2022; 9:825239.
44. Zivanovic I, Rautenberg O, Lobodasch K, et al. Urethral bulking for recurrent stress urinary incontinence after midurethral sling failure. Neurourol Urodyn. 2017; 36(3):722-726.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Breyer BN, Kim SK, Kirkby E, et al. Updates to incontinence after prostate treatment: AUA/GURS/SUFU Guideline (2024). 2024; 212(4):531-538.
2. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination: Incontinence control devices. NCD #230.10. Effective October 7, 1996. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=241&ncdver=1&DocID=230.10&bc=gAAAAAgAAAAAAA%3d%3d&. Accessed on March 18, 2026.
3. Fleischmann N, Chughtai B, Plair A, et al. Urethral bulking. Urogynecology (Phila). 2024; 30(8):667-682.
4. Herbison P, Dean N. Weighted vaginal cones for urinary incontinence. Cochrane Database Syst Rev. 2013;(7):CD002114.
5. Kang D, Han J, Neuberger MM, et al. Transurethral radiofrequency collagen denaturation for the treatment of women with urinary incontinence. Cochrane Database Syst Rev. 2015;2015(3):CD010217.
6. Kirchin V, Page T, Keegan PE, et al. Urethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev. 2017;(7):CD003881.
7. Kobashi KC, Vasavada S, Bloschichak A, et al. Updates to surgical treatment of female stress urinary incontinence (SUI): AUA/SUFU Guideline (2023). J Urol.2023; 209(6):1091-1098.
8. U.S. Food and Drug Administration (FDA). Bulkamid^® Urethral Bulking System instructions for use. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170023D.pdf. Accessed on March 18, 2026.
9. U.S. Food and Drug Administration (FDA). De novo approval letter. inFlow^™ Intraurethral Valve-Pump and Activator. No. DEN130044 Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/den130044.pdf. Accessed on March 18, 2026.
10. U.S. Food and Drug Administration (FDA). Premarket Approval (PMA). Macroplastique® Implants. No. P040050. Rockville, MD: FDA. October 30, 2006. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P040050 Accessed on March 18, 2026.
11. U.S. Food and Drug Administration (FDA) 510(k) Premarket notification database. Novasys Medical Transurethral Radiofrequency System. 510(k) Summary. No. K042132. Rockville, MD: FDA July 22, 2005. Available at: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K042132. Accessed on March 18, 2026.
12. U.S. Food and Drug Administration (FDA) 510(k) Premarket notification database. SurX RF System. 510(k) Summary. No. K020952. Rockville, MD: FDA. May 30, 2002. Available at: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K020952. Accessed on March 18, 2026.
13. U.S. Food and Drug Administration (FDA). Summary of safety and effectiveness. AMS Sphincter 800^™ Urinary Prosthesis. No. P000053. Rockville, MD: FDA. June 14, 2001. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P000053. Accessed on March 18, 2026.
14. U.S. Food and Drug Administration (FDA). Summary of safety and effectiveness data. Coaptite®. No. P040047. Rockville, MD: FDA. November 10, 2005. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040047b.pdf. Accessed on March 18, 2026.
15. U.S. Food and Drug Administration (FDA). Summary of safety and effectiveness data. Durasphere™ Injectable Bulking Agent. No. P980053. Rockville, MD: FDA. September 13, 1999. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf/P980053B.pdf. Accessed on March 18, 2026.
16. U.S. Food and Drug Administration (FDA). Summary of safety and effectiveness. ProACT^™ Adjustable Continence Therapy for Men. No. P130018. Rockville, MD: FDA. November 24, 2015. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130018B.pdf. Accessed on March 18, 2026.
17. U.S. Food and Drug Administration (FDA). 510(k) Summary of safety and effectiveness. Viveve 2.0 System. K193611. Rockville, MD: FDA. January 16, 2020. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193611.pdf. Accessed on March 18, 2026.

1. National Kidney and Urologic Diseases Information Clearinghouse. Bladder control problems. Last Reviewed July 2021. Available at: https://www.niddk.nih.gov/health-information/urologic-diseases/bladder-control-problems. Accessed on March 18, 2026.

AMS Sphincter 800
Artificial Urinary Sphincter, (AUS)
Bulkamid
Coaptite
Durasphere
InFlow intraurethral valve-pump
Lyrette
Macroplastique
Periurethral Injection of Bulking Agents
ProACT System
Renessa
Transurethral Radiofrequency Energy Collagen Micro-Remodeling
Transvaginal Radiofrequency
Vaginal Weight Training
Viveve

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

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