Stress Urinary Incontinence

34

Review clinical trials related to Stress Urinary Incontinence. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Synchronized Core-Pelvic Floor Activation in Urinary Incontinence

This study aims to investigate whether co-activation of the pelvic floor and core muscles improves treatment outcomes in individuals with urinary incontinence. Participants diagnosed with stress, or mixed urinary incontinence will undergo a 12-week pelvic floor physiotherapy program, with or without additional core muscle co-activation exercises. Changes in urinary incontinence severity, pelvic floor muscle function, core muscle activation, and quality of life will be evaluated.

Participants needed: 50
Trial details
Age: 18-65Biological sex: FemaleType: InterventionalSponsor: Bezmialem Vakif UniversityUpdated: Jul 1, 2026Locations: 1
Eligibility criteria

Aged between 18 and 65 years [+3]

Pregnancy [+6]

Status: Recruiting

Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

The objective of this post market, clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including robotic assisted) using either Gynemesh PS Mesh or Artisyn Mesh in women undergoing surgery for SUI and POP.

Participants needed: 1,000
Trial details
Age: 21+Biological sex: FemaleType: ObservationalSponsor: Ethicon, Inc.Updated: Jun 26, 2026Locations: 10
Eligibility criteria

Stress urinary incontinence symptoms [+6]

Physical or psychological condition which would impair registry participation or... [+9]

Status: Not yet recruiting

Effect of Different Pelvic Floor Loading Techniques on Women With Stress Urinary Incontinence

The purpose of this study is to compare the effects of different pelvic floor loading techniques (graduated positions versus graduated weights) on women with stress urinary incontinence.

Participants needed: 40
Trial details
Age: 30-40Biological sex: FemaleType: InterventionalSponsor: Cairo UniversityUpdated: Jun 24, 2026Locations: 1
Eligibility criteria

All women are suffering from Stress urinary incontinence. [+3]

Patient with denervated pelvic floor muscle, urinary tract infection, severe pro... [+6]

Status: Recruiting

Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence

This is a multicentered, double-blind, randomized controlled, surgical trial of 358 women with inadequate symptom relief of stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence (MUI) after conservative care. The Primary Aim is to determine the comparative effectiveness (as defined by "much" or "very much" better on PGI-I) of transurethral bulking agent (TBA) \[for 1 or 2 injections in 12 months\] vs. single-incision sling (SIS) 12 months after treatment intervention in women with predominant stress urinary incontinence (SUI).

Participants needed: 358
Trial details
Age: 21+Biological sex: FemaleType: InterventionalSponsor: NICHD Pelvic Floor Disorders NetworkUpdated: Jun 8, 2026Locations: 7
Eligibility criteria

Women ≥ 21 years [+6]

Anterior/apical vaginal prolapse beyond the hymen (>0 on POPQ) [+12]

Status: Recruiting

Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System

The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT ABBREVO® Continence System in women undergoing Mid-urethral sling surgery for Stress Urinary Incontinence (SUI).

Participants needed: 195
Trial details
Age: 21+Biological sex: FemaleType: ObservationalSponsor: Ethicon, Inc.Updated: Jun 5, 2026Locations: 4
Eligibility criteria

Stress urinary incontinence symptoms [+6]

Physical or psychological condition which would impair study participation or ar... [+7]

Status: Recruiting

BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)

The goal of this clinical trial is to learn if retropubic midurethral sling (RP-MUS) or bulkamide injection (PAHG) at the time of pelvic organ prolapse repair is better from the patient's perspective. The main questions it aims to answer are: What is the average difference in the urogenital distress inventory (UDI) long form score 24 months after surgery for each procedure? Which procedure has the fewest complications and lowest short- and long-term morbidity profile? Participants will: Be blinded and randomized to one of two procedures for the duration of the study, 24 months. Complete 6 total visits for the clinical trial including validated questionnaires. Few participants will be selected to complete a qualitative interview at 3 timepoints over 24 month duration of the study.

Participants needed: 476
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University Hospitals Cleveland Medical CenterUpdated: Jun 1, 2026Locations: 1
Eligibility criteria

Women ≥ 18 years of age. [+3]

Patients undergoing pelvic organ prolapse repair using mesh or biologic augmenta... [+10]

Status: Recruiting

Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer

Background: Men who are treated for prostate cancer often develop urinary leakage (incontinence). An experimental device that uses electrical impulses to stimulate pelvic floor muscles and surrounding tissues may help. Objective: To see if the Elidah device can reduce urinary incontinence after prostate treatment. Eligibility: Men aged 18 years and older who have had moderate urinary incontinence for at least 6 months after treatment for prostate cancer. Design: Participants will be in the study for about 9 weeks. They will be screened. They will have a physical exam with urine tests. The Elidah device consists of a Controller and a GelPad. The Controller sets the strength of electrical impulses. The GelPad is placed against the skin under the pelvis. Participants will be given an Elidah device and taught how to use it at home. They will use the device once a day for 20 minutes at a time; they will do this 5 days a week for 6 weeks. Participants will complete a daily log. They will record the strength of electrical impulses (0-35); the number of incontinence episodes; the type of incontinence episode; and the number of used pads. Participants will do a pad weight test. For 3 days before and 3 days after using the Elidah device, they will collect all of their used pads for each 24-hour period into a sealed plastic bag. They will also collect a second set of bags that contain dry versions of each product used. Participants will have clinic visits after using the device for 3 weeks and after finishing the 6 weeks of treatment. Participants will complete 15-minute questionnaires.

Participants needed: 41
Trial details
Phase: Phase 2Age: 18-120Biological sex: MaleType: InterventionalSponsor: National Cancer Institute (NCI)Updated: Apr 15, 2026Locations: 1
Eligibility criteria

Participants must be male. [+8]

Change of therapy for prostate cancer planned during the study intervention. [+12]

Status: Not yet recruiting

Prophylactic Antibiotics for Outpatient Urethral Bulking

The purpose of this study is to evaluate whether taking prophylactic (preventative) antibiotics at the time of standard of care clinic-based urethral bulking reduces the risk of post-procedural urinary tract infection (UTI).

Participants needed: 150
Trial details
Phase: Phase 4Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of MiamiUpdated: Mar 30, 2026Locations: 2
Eligibility criteria

Women ≥ 18 years of age. [+5]

Contraindications to both oral antibiotics including antibiotic allergies or sig... [+8]

Status: Not yet recruiting

Impact of Virtual Reality Pelvic Floor Training on Postpartum Stress Urinary Incontinence

This study will be conducted to determine the effect of virtual reality (VR) on pelvic floor training on postpartum stress urinary incontinence (SUI) .

Participants needed: 50
Trial details
Age: 22-35Biological sex: FemaleType: InterventionalSponsor: Cairo UniversityUpdated: Mar 6, 2026Locations: 1
Eligibility criteria

Females, aged 22-35 years. [+4]

Females Diagnosed with neurological conditions affecting pelvic control (e.g., m... [+3]

Status: Recruiting

Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure

The purpose of this early feasibility prospective study is to gain initial understanding of the effect of acute peri-urethral neurostimulation on the perineal nerves on intra-urethral pressure.

Participants needed: 20
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Corewell Health EastUpdated: Dec 11, 2025Locations: 1
Eligibility criteria

Female aged 18 years old or older [+4]

Predominant urge incontinence per patient report or medical record [+19]

Status: Recruiting

BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence

Stress urinary incontinence (SUI) is a condition that affects both men and women. SUI is the involuntary leakage of urine caused by an increase in intra-abdominal pressure from activities such as exercise, coughing, laughing, or sneezing. It can significantly affect quality of life as patients avoid activities or behaviors that cause leakage. This clinical trial will compare the efficacy of the Emsella chair to sham and determine if electromagnetic technology is effective in the treatment of SUI.

Participants needed: 110
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Corewell Health EastUpdated: Dec 11, 2025Locations: 1
Eligibility criteria

Able to read, understand, and provide written, dated, informed consent prior to... [+5]

Pelvic floor physical therapy, including muscle training and/or electrostimulati... [+20]

Status: Recruiting

Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study)

The primary aim of this study is to assess the utility of prophylactic oral antibiotics at time of Bulkamid transurethral bulking to reduce the incidence of urinary tract infection (UTI) in the immediate postoperative period. The secondary aims of the study include assessing UTI rates and success rates if patients require temporary indwelling catheter versus intermittent self-catheterization (ISC).

Participants needed: 138
Trial details
Phase: Phase 4Age: 18-50Biological sex: FemaleType: InterventionalSponsor: Ohio State UniversityUpdated: Oct 8, 2025Locations: 1
Eligibility criteria

Patients evaluated by a pelvic floor specialist (either urogynecologist or urolo... [+3]

Contraindications to both oral antibiotics including antibiotic allergies or sig... [+8]

Status: Not yet recruiting

Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy

The purpose of this study is to compare change in pelvic floor symptoms between patients receiving medical therapy for weight loss and surgical treatment for weight loss. Examples of pelvic floor symptoms include urinary incontinence, urinary urgency, urinary frequency, fecal incontinence, and vaginal prolapse. Participants in this study do not need to have any pelvic floor symptoms to enroll in the study. Understanding how different types of weight loss treatment impact pelvic floor symptoms will help clinicians guide which weight loss treatments are recommended for patients with pelvic floor symptoms in the future.

Participants needed: 200
Trial details
Age: 18-90Biological sex: FemaleType: ObservationalSponsor: Hartford HealthCareUpdated: Sep 16, 2025Locations: 1
Eligibility criteria

female [+10]

Pregnant [+6]

Status: Recruiting

Desara ® One Single Incision Sling 522 Study

A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.

Participants needed: 300
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Caldera Medical, Inc.Updated: Sep 19, 2025Locations: 15
Eligibility criteria

Female ≥ 18 of age. [+10]

Subject reports baseline pelvic pain ≥ 2 on 10 point Numeric Rating Scale (NRS). [+24]

Status: Recruiting

Efficacy/Safety of Midurethral Sling

The trans-obturator tape (TOT), which exhibits a satisfactory cure rate and a relatively diminished invasiveness, has been increasingly accepted as a surgical treatment of stress urinary incontinence (SUI) patients. Nevertheless, in contrast to the well-recognized therapeutic benefit of the enhanced resistance to the bladder continence during urine storage, if the voiding function of the bladder adapts to the TOT-enhanced outlet resistance has not been adequately investigated. This study retrospectively assayed the voiding efficacy of each voiding cycle, to clarify if the thermodynamic efficacy of the bladder was modified in response to the TOT surgery.

Participants needed: 200
Trial details
Age: 30-100Biological sex: FemaleType: InterventionalSponsor: Mackay Medical CollegeUpdated: Sep 5, 2025Locations: 1
Eligibility criteria

Clinical diagnosis of stress urinary incontience [+1]

Exclusion criteria will be a history of (1) cardiovascular, (2) neurological, or...

Status: Not yet recruiting

Effect of Coping Training on Attitudes, Sleep, and Quality of Life in Women With Stress Urinary Incontinence

This study aims to examine the effects of urinary incontinence management training provided to postmenopausal women on their urinary incontinence attitudes, sleep, and quality of life. Hypothesis H1: Following the urinary incontinence management training, there will be an increase in urinary incontinence attitudes, sleep, and quality of life in the women in the experimental group compared to the women in the control group.

Participants needed: 96
Trial details
Age: 45-55Biological sex: FemaleType: InterventionalSponsor: Ondokuz Mayıs UniversityUpdated: Aug 17, 2025Locations: 1
Eligibility criteria

Female [+6]

Having a communication barrier [+4]

Status: Recruiting

Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery

This study is a single-blind, randomized controlled trial evaluating whether changing the width of the surgical tape (mesh) used in transobturator tape (TOT) surgery improves treatment results in women with stress urinary incontinence (SUI). Two mesh widths are being compared: a 1.2 cm mesh (new method) and a 1.0 cm mesh (standard method). The main goal is to find out if the wider mesh leads to better urinary control and fewer complications. Participants will be followed for one year to measure cure rates, symptom improvement, and satisfaction.

Participants needed: 106
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Izzet CelegenUpdated: Jul 11, 2025Locations: 1
Eligibility criteria

Female patients aged 18 years or older [+6]

History of prior midurethral sling surgery [+8]

Status: Recruiting

Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension

This study aims to compare the success rate and complications following laparoscopic standard Burch colposuspension and laparoscopic modified Burch colposuspension (Transobturator tape like)

Participants needed: 120
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Al-Azhar UniversityUpdated: May 29, 2025Locations: 1
Eligibility criteria

Women with genuine stress urinary incontinence. [+2]

Mixed incontinence with predominant Urge urinary incontinence. [+8]

Status: Recruiting

Optimized Acupuncture Treatment for Female Stress Urinary Incontinence

This multicenter randomized controlled trial is designed to explore a relatively suitable application of acupoint combinations and to provide certain clinical evidence for the optimization of acupuncture treatment of female SUI.

Participants needed: 360
Trial details
Age: 40-75Biological sex: FemaleType: InterventionalSponsor: Yin PingUpdated: May 22, 2025Locations: 1
Eligibility criteria

Patients with mild to moderate SUI mentioned in the diagnostic criteria above; [+2]

Other types of urinary incontinence (urgent, overflow or mixed). [+10]

Status: Recruiting

The Effectiveness of Prophylactic Antibiotics for Urethral Bulking

The goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections.

Participants needed: 70
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Atlantic Health SystemUpdated: Apr 8, 2025Locations: 1
Eligibility criteria

Patients scheduled to undergo a urethral bulking procedure [+1]

History of recurrent urinary tract infections [+5]

Status: Recruiting

Outcomes of Limited Postoperative Restrictions Following Sling Placement: A Randomized Controlled Trial

The purpose of this research study is to better understand optimal restrictions for patients postoperatively following a mesh urethral sling placement for patients with stress urinary incontinence. Patients undergoing a midurethral sling procedure will be assigned to one of two groups. One group with be given standard postprocedural restrictions including instructions to avoid moderate activity and no lifting over 15lbs for six weeks after surgery. The other group will have fewer restrictions, with no restrictions on activity or lifting. Participants will complete surveys at 2 weeks, 3 months and 1 year following their procedure to help providers better understand how patients are following postoperative restrictions and if there were any differences in the outcome of the procedure between the two groups.

Participants needed: 84
Trial details
Age: 18-99Biological sex: FemaleType: InterventionalSponsor: University of IowaUpdated: Apr 1, 2025Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

Effectiveness and Cost-effectiveness of PelviSense, a Novel Biofeedback Device for Stress Urinary Incontinence in Women

Aims: (1) Investigate the efficacy of PelviSense-assisted PFMT compared with PFMT alone for improving SUI symptom severity in women; (2) Compare the cost-effectiveness of the PelviSense device against PFMT alone for treating SUI in women; (3) Explore the views of women regarding the use of the PelviSense device as an adjunct to PFMT and the impacts of the PelviSense device on their lives and well-being. Design and subjects: A sequential, embedded, experimental mixed-methods design, including a randomised controlled trial (RCT) and semi-structured focus groups, will be conducted alongside an economic evaluation. The proposed study will include 142 women with SUI or stress-predominant mixed urinary incontinence. Interventions: Women will be randomly allocated to one of two groups (PelviSense or PFMT alone \[control\]). The PelviSense group will perform PFMT with assistance from the PelviSense device, and the control group will perform PFMT without biofeedback (i.e., PFMT alone). Outcome measures: International Consultation on Incontinence Questionnaire-Short Form, one-hour pad test, Modified Oxford Scale, EQ-5D-5L, and electronic cost diary. Data analysis and expected results: Statistical analysis will be conducted using analysis of covariance. The PelviSense group is expected to report significant improvements in primary and secondary outcomes compared with the PFMT alone group. The PelviSense group will yield cost savings and result in lower health care utility compared with the PFMT alone group.

Participants needed: 142
Trial details
Age: 35-65Biological sex: FemaleType: InterventionalSponsor: The Hong Kong Polytechnic UniversityUpdated: Mar 17, 2025Locations: 2
Eligibility criteria

non-pregnant women with stress urinary incontinence (SUI), [+3]

women <6 months postpartum, [+5]

Status: Recruiting

Pessary Experience Study

Pessaries are silicone devices inserted into the vagina for treatment of pelvic organ prolapse or stress urinary incontinence. They are adequate treatment options for patients who are poor surgical candidates, those who decline surgical intervention, or as a temporizing measure in those ultimately planning surgery. Most studies suggest that about 75% of patients are able to be successfully fit with a pessary, but about 50% discontinue pessary use within 12 months of initiation. The purpose of this study is to determine why pessaries are discontinued.

Participants needed: 30
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: University of VirginiaUpdated: Jan 28, 2025Locations: 1
Eligibility criteria

English-speaking women aged 18 years or older [+3]

Pregnant women [+7]

Status: Not yet recruiting

Preliminary Outcome Of Tecar On Stress Urinary Incontinence, Pelvic Floor Strength And Sexual Satisfaction In Women With Vaginal Relaxation Syndrome

Forty women aged 50-60 years with a body mass index (BMI) of 25 kg/m2 to 30 kg/m2, who complain of stress urinary incontinence and vaginal laxity, will be separated randomly into two equivalent groups. In group (A) 20 women will receive TECAR therapy for 15 min and pelvic floor exercise for 20 min, while in group (B), 20 females will receive sham treatment for 15 min and pelvic floor exercise for 20 min twice per week for 8 weeks. Both groups wil be assessed using a perineometer as an assessment tool for pelvic floor muscle strength muscles and the Visual Analog Scale, ICIQ-UI short form questionnaire about the frequency of urinary incontinence symptoms, Millheiser Sexual Satisfaction Scale, and the Sexual Quality of Life Questionnaire-Female (SQOL-F) to assess sexual satisfaction by each patient before, after 4 weeks, and after 8 weeks of treatment

Participants needed: 40
Trial details
Age: 50-60Biological sex: FemaleType: InterventionalSponsor: Cairo UniversityUpdated: Jan 23, 2025
Eligibility criteria

participants are multipara at least two times with sexual activity for at least...

pregnancy, use of photosensitive medicines, vaginal bleeding injury or infection...

Status: Recruiting

The Follow-up After Shorter Tapes Study. Effectiveness and Safety of Shorter Trans-obturator Tapes.

Urinary incontinence after pregnancy and labor affects 1 in 3 women and has a negative impact on quality of life (QOL), limiting women's physical activity and impairing sexual function. The traditional surgical method treating female urinary incontinence is to implant a sub-urethral synthetic sling, the currently preferred method in Norway. The majority of women treated with synthetic slings obtain great improvement in QOL, but a few experience severe complications including chronic pelvic pain. Several countries, therefore, have reverted to older, less effective surgical methods to avoid synthetic material. Awareness of severe complications has, in some Norwegian hospitals, led to a shift in technique towards shorter slings. With shorter slings, the goal is to achieve the same grade of continence as traditional slings, but with fewer serious complications. The long-term results and complications of these shorter slings are mostly unknown. Akershus University Hospital (AHUS) shifted to shorter slings early, in 2009, using a single incision mini-sling (SIMS) Ajust. Due to costs, AHUS changed to the intermediate sling TVT-O Abbrevo in 2016. Through this study, we hope to establish if shorter slings have the same long-term results as traditional slings, and to investigate if shorter slings are safer than traditional slings, with less long-term complications, such as chronic pelvic pain. We plan to perform a long-term follow-up of women having had surgery with shorter slings at AHUS. All patients operated with either SIMS Ajust or TVT-O Abbrevo at AHUS between 2009 and 2020 will be invited to a long-term follow-up. The study participants will be asked to fill in validated questionnaires regarding symptoms of urine leakage, QOL, any chronic pain related to the surgery, debut of pain, level of pain and any treatments for the pain. All women treated with the current used sling Abbrevo is invited to a physical examination including testing of their voiding function and a gynecologic examination to check for complications. 2D- and 3D ultrasound scans will be done on the TVT-O Abbrevo group to evaluate the position-, attachment- and any misplacement of the sling. Women experiencing insufficient long-term results, such as chronic pain, will be offered a full examination and treatment.

Participants needed: 750
Trial details
Age: 25-90Biological sex: FemaleType: ObservationalSponsor: University Hospital, AkershusUpdated: Dec 13, 2024Locations: 1
Eligibility criteria

All women operated for stress-urinary incontinence with TVT-O Abbrevo of Ajust i...

Women operated with other incontinence operations or slings.