Stress Urinary Incontinence (SUI)

22

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

Condition / disease
Location
Status: Recruiting

Pivotal Study of Voro Urologic Scaffold

The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm. The study is a multi-center, single blind, randomized, controlled trial. Up to 266 participants will be treated at up to 30 centers in the United States. The study will consist of a Baseline visit, implantation during robotic assisted radical prostatectomy (RARP), catheter removal, 6 weeks, 6 months, 12 months, 18 months, and 24 months.

Participants needed: 266
Trial details
Phase: Phase 3Age: 45+Biological sex: MaleType: InterventionalSponsor: Levee Medical, Inc.Updated: Jun 23, 2026Locations: 19
Eligibility criteria

Male >= 45 years of age of any race and ethnic group [+6]

Malignant tumors with known bladder neck or urethral sphincter invasion or metas... [+28]

Status: Not yet recruiting

Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery

Suzetrigine is a selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. This single-center stepped-wedge randomized clinical trial evaluates whether a suzetrigine-based postoperative analgesic regimen provides non-inferior pain control compared with standard opioid-inclusive care following transvaginal pelvic reconstructive surgery. The study will enroll 120 participants and assess pain, opioid consumption, adverse events, and functional recovery.

Participants needed: 120
Trial details
Phase: Phase 4Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of California, Los AngelesUpdated: Jun 2, 2026Locations: 1
Eligibility criteria

Age ≥ 18 years. [+2]

Chronic opioid use. [+4]

Status: Not yet recruiting

Differences in Pelvic Floor Motion Level Among Chinese Women and Construction of an Assessment System

The purpose of this study is to integrate millimeter-wave radar technology to investigate the dynamic movement characteristics of the pelvic floor muscles in patients with different Body Mass Index (BMI) and stress urinary incontinence. Based on this, a large database of pelvic floor movement parameters for Chinese women will be constructed, and a multi-subgroup standard atlas of pelvic floor muscle movement will be established to promote the standardized application of this technology in obstetrics and gynecology clinical assessments. This study also aims to explore the clinical value of pelvic floor movement assessment within the pelvic floor evaluation system, providing directions and insights for establishing a systematic evaluation system and standardizing the diagnosis and treatment of pelvic floor disorders.

Participants needed: 2,000
Trial details
Age: 18-60Biological sex: FemaleType: ObservationalSponsor: Peking Union Medical College HospitalUpdated: May 27, 2026Locations: 20
Eligibility criteria

Female, aged between 18 and 60 years old [+3]

Participants with cognitive behavioral disorders, mental illnesses, or those who... [+7]

Status: Recruiting

Development and Validation of a Risk Prediction Model for De Novo Stress Urinary Incontinence After Pelvic Floor Reconstruction Surgery

This observational study aims to develop a predictive model for the occurrence of new-onset stress urinary incontinence (SUI) after pelvic organ prolapse (POP) repair surgery in women. The primary questions it seeks to answer are: Which risk factors and anatomical characteristics predispose women to new-onset stress urinary incontinence following pelvic organ prolapse repair surgery? Female POP patients without any preoperative symptoms of urinary incontinence will receive telephone follow-ups at 3, 6, and 12 months after undergoing standard surgical treatment.

Participants needed: 382
Trial details
Age: 20-90Biological sex: FemaleType: ObservationalSponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUpdated: May 22, 2026Locations: 1
Eligibility criteria

Patients with pelvic organ prolapse quantification (POP-Q) stage II or higher; [+2]

Patients confirmed to have urinary incontinence before surgery; [+6]

Status: Recruiting

Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)

Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system.

Participants needed: 86
Trial details
Age: 22+Biological sex: FemaleType: InterventionalSponsor: Amber Therapeutics LtdUpdated: May 15, 2026Locations: 7
Eligibility criteria

Female. NB: the definition of female refers to sex at birth. [+8]

Patient is pregnant, breastfeeding, or plans to become pregnant at any time in t... [+31]

Status: Not yet recruiting

Baseline Knowledge of Stress Urinary Incontinence Among Urogynecology Patients

The goal of this prospective study is to assess whether a standardized educational flyer (pamphlet) improves knowledge about stress urinary incontinence (SUI) in adult females attending a urogynecology clinic. It will also explore how participant characteristics relate to treatment preferences. The main questions it aims to answer are: Does reading a standardized SUI patient information flyer improve participants' knowledge of SUI? How do patient characteristics influence treatment preferences for SUI? Participants will: Complete a self-administered questionnaire assessing knowledge of SUI, including its definition, pathophysiology, risk factors, natural history, and treatment options (this questionnaire is not part of standard care). Review a standardized SUI educational flyer during their clinic visit. Complete the same questionnaire again after reading the pamphlet to assess any change in knowledge. Questionnaire scores before and after reading the flyer will be compared. Secondary outcomes include participant characteristics and reported treatment preferences.

Participants needed: 90
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Sunnybrook Health Sciences CentreUpdated: Apr 28, 2026Locations: 1
Eligibility criteria

Participants are patients referred to Sunnybrook Health Sciences Centre Urogynec... [+3]

Under the age of 18 years [+3]

Status: Not yet recruiting

The Effect of Periurethral Injection of Platelet Rich Plasma Versus Mid-urethral Sling in Treatment of Stress Urinary Incontinence : a Randomized Clinical Trial

this study used to compare efficacy between platelet rich plasma periurethral injection versus mid urethral sling ( trans obturator tape ) in treatment of stress urinary incontinence

Participants needed: 42
Trial details
Age: 26-66Biological sex: FemaleType: InterventionalSponsor: Ain Shams UniversityUpdated: Apr 24, 2026
Eligibility criteria

stress urinary incontinence identified by urodynamic study [+1]

previous GUS operation [+4]

Status: Recruiting

Dynamic Neuromuscular Stabilization vs Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence

This randomized controlled trial aims to compare the pre- and post-treatment effects of Dynamic Neuromuscular Stabilization (DNS) training and Pelvic Floor Muscle Training (PFMT) on pelvic floor muscle function, pelvic floor morphometry, urinary symptoms, quality of life, sexual function, and physical activity levels in women with stress urinary incontinence (SUI). Participants diagnosed with SUI by a specialist physician will be randomly assigned to one of three groups: DNS, PFMT, or a control group. Both DNS and PFMT interventions will be delivered as 12-week home exercise programs, performed five days a week and at least three times per day. To support adherence, participants will use an exercise diary. In addition, participants in the DNS and PFMT groups will attend the clinic twice a week for supervised sessions led by a physiotherapist. The control group will receive a brochure containing lifestyle and bladder health recommendations but will not engage in any structured exercise program.

Participants needed: 51
Trial details
Age: 18-65Biological sex: FemaleType: InterventionalSponsor: Izmir Katip Celebi UniversityUpdated: Mar 25, 2026Locations: 1
Eligibility criteria

Female participants aged between 18 and 65 years [+4]

Pregnancy [+14]

Status: Recruiting

The Impact of Breathing Training on PPSUI: A Randomized Controlled Trial

\*\*Clinical Trial\*\* This clinical trial aims to investigate the clinical therapeutic effects of breathing training on postpartum stress urinary incontinence (PPSUI). Participants will: All participants will receive standard postpartum care and recovery guidance, including routine examinations, health counseling, basic postpartum recovery recommendations, and educational information. Control Group: Participants will receive conventional pelvic floor rehabilitation therapy, which may include one or a combination of the following: magnetic stimulation therapy, electromyographic biofeedback therapy, and manual therapy. The specific treatment methods and frequency will be determined based on individual patient conditions. Intervention Group: In addition to the same pelvic floor rehabilitation therapy as the control group, participants will receive breathing training. Before each session, participants will empty their bladder. The breathing training will be conducted under researcher supervision and guidance, with each session lasting 20 minutes, administered once daily, three times per week for 6 weeks. Participants are encouraged to perform the training in the hospital under researcher supervision. Those unable to attend in-person sessions may conduct home-based training after mastering the technique and must report their training status to researchers afterward. Researchers will monitor weekly training completion and provide timely reminders to ensure adherence. If dizziness or difficulty breathing occurs during training, participants must immediately discontinue the session.

Participants needed: 58
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Jie LiUpdated: Mar 27, 2026Locations: 1
Eligibility criteria

Age: ≥18years [+2]

Diabetes mellitus [+16]

Status: Not yet recruiting

Efficacy and Safety of Intravaginal EMS Treatments in Women With Exclusive or Predominant Stress Urinary Incontinence

The investigator wants to evaluate the efficacy of a specific intravaginal Electrical Muscle Stimulation (EMS), in the treatment of exclusive or predominant stress urinary incontinence (SUI) symptoms in women. The investigator's aim is to determine the device's impact (the device is VTone) on reducing urinary incontinence episodes and on improving women's quality of life.

Participants needed: 15
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: IRCCS San RaffaeleUpdated: Mar 13, 2026
Eligibility criteria

Women with minimum age of 18 years . [+4]

Pacemaker or internal defibrillator, or any other metallic or electronic implant... [+31]

Status: Recruiting

Stress Urinary Incontinence for Female Patients (CGM MUIT-2301)

This study is a multicenter, prospective, randomized, double-blind, sham-controlled clinical trial conducted in female patients with stress urinary incontinence.

Participants needed: 96
Trial details
Age: 19+Biological sex: FemaleType: InterventionalSponsor: Ceragem Clinical Inc.Updated: Feb 27, 2026Locations: 1
Eligibility criteria

Patients with urine leakage of ≥1 g on the standardized pad test

Patients with mixed urinary incontinence with predominant urgency urinary incont... [+2]

Status: Recruiting

Dynamic Neuromuscular Stabilization Exercises in Women With Urinary Incontinence

Stress urinary incontinence (SUI) is defined by the International Continence Society as the complaint of involuntary leakage of urine during physical exertion, including sports activities, or during sneezing or coughing. In continent women, an automatic response-namely, a reflex pelvic floor muscle (PFM) contraction, also known as pre-contraction-occurs either prior to or during physical exertion. Although there is strong evidence supporting the effectiveness of pelvic floor muscle training (PFMT) in the treatment of SUI, there has been a growing interest in exploring alternative exercise-based interventions. Dynamic Neuromuscular Stabilization (DNS) is a manual and rehabilitative approach developed by Professor Pavel Kolar. It is grounded in the scientific principles of developmental kinesiology and aims to optimize the function of the movement system. Currently, DNS is successfully employed in the rehabilitation of various neurological, musculoskeletal, pediatric, and sports-related injuries. DNS incorporates the subconscious and synergistic activation of the deep core muscles responsible for intra-abdominal pressure (IAP) regulation and spinal stability-namely, the diaphragm, transversus abdominis, multifidus, and pelvic floor muscles-as well as the global musculature. Considering the potential mechanisms of DNS, we hypothesize that DNS exercises, through IAP regulation directed toward the pelvic cavity and contributing to stabilization, could serve as an effective and innovative approach for women with SUI. The hypotheses of this study are as follows: H1.1: DNS is as effective as PFMT in reducing urinary symptoms in women with SUI. H1.2: DNS is as effective as PFMT in improving PFM function in women with SUI.

Participants needed: 62
Trial details
Age: 18-62Biological sex: FemaleType: InterventionalSponsor: Izmir University of EconomicsUpdated: Feb 17, 2026Locations: 1
Eligibility criteria

Female gender, [+5]

Prior history of pelvic floor muscle training, [+8]

Status: Recruiting

Mesh-Free Versus Mesh-Based Surgery for Female Stress Urinary Incontinence: A Prospective Comparison of Pubo-Urethral Ligament Plication and Transobturator Tape

This prospective clinical study aims to compare the short-term effectiveness, safety, and patient-reported outcomes of two surgical techniques used for the treatment of female stress urinary incontinence (SUI): Pubo-Urethral Ligament Plication (PLP), a mesh-free native tissue repair method, and the Transobturator Tape (TOT) procedure, a commonly used mesh-based mid-urethral sling technique. The study evaluates continence improvement, perioperative and postoperative complications, operative time, hospital stay, postoperative pain, and patient satisfaction. The goal is to provide evidence on whether a mesh-free surgical option such as PLP can offer comparable outcomes to mesh-based TOT, particularly for patients seeking alternatives to synthetic materials.

Participants needed: 147
Trial details
Age: 18-80Biological sex: FemaleType: InterventionalSponsor: Mehmet IncebıyikUpdated: Dec 18, 2025Locations: 1
Eligibility criteria

Mixed urinary incontinence with predominant urge symptoms

Status: Not yet recruiting

The Effect of Different Delivery Positions on Pelvic Floor Function.

This study is a cohort clinical study. Baseline data were collected from cases recruited at pregnancy, and the eligible subjects were grouped into 3 groups according to different delivery position including supine position group, upright position group, and lateral position group. Different delivery positions along with respectively timeand obstetric conditions were recorded at delivery. Pelvic floor function assessments were performed at postpartum.

Participants needed: 669
Trial details
Age: 20-35Biological sex: FemaleType: ObservationalSponsor: Peking University People's HospitalUpdated: Nov 25, 2025Locations: 1
Eligibility criteria

Age 20-35 years old [+5]

Pelvic floor organ prolapse beyond the hymen limbus; [+2]

Status: Recruiting

CHM for Female Stress Urinary Incontinence

This single-arm, open-label pilot clinical trial will test the hypothesis that S-2196, a Chinese herbal medicine formula, will show efficacy and safety in alleviating the amount and frequency of urinary incontinence in female individuals with stress urinary incontinence. All participants (n=15) will receive 1 week of screening, 2 weeks of intervention, and 1 week of follow-up.

Participants needed: 15
Trial details
Age: 55+Biological sex: FemaleType: InterventionalSponsor: Hong Kong Baptist UniversityUpdated: Nov 20, 2025Locations: 1
Eligibility criteria

Females aged ≥55 years [+5]

Patients with other types of urinary incontinence, such as neurogenic urinary in... [+10]

Status: Not yet recruiting

The Effectiveness of Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy in Postmenopausal Women With Stress Urinary Incontinence

The objective of this clinical trial is to investigate whether the combination of pelvic floor muscle training (PFMT) and topical estrogen is more effective in treating stress urinary incontinence (SUI) in postmenopausal women compared to topical estrogen alone. The trial will also analyze factors related to the outcomes of the combined therapy. The key questions this trial aims to answer are: * Does the combination of PFMT and topical estrogen improve symptoms of stress urinary incontinence in postmenopausal women better than topical estrogen alone? * Which factors are associated with the effectiveness of the combined therapy? Researchers will compare the group receiving the combined therapy (pelvic floor muscle training plus topical estrogen) with the group receiving topical estrogen alone to determine whether adding PFMT to estrogen therapy provides additional treatment benefits for SUI in postmenopausal women. Participants will: \- Be randomly assigned to one of two groups: Group 1: Undergo a pelvic floor muscle training (PFMT) program combined with topical estrogen therapy (e.g., vaginal cream/application,...). Group 2: Receive topical estrogen therapy alone (e.g., vaginal cream/application,...). * Follow the assigned intervention protocol for a specified duration. * Attend regular clinic visits for clinical examinations, assessment of incontinence severity, and related measurements. * Monitor and record their incontinence symptoms and the frequency of urine leakage during daily activities.

Participants needed: 115
Trial details
Biological sex: FemaleType: InterventionalSponsor: Hanoi Medical UniversityUpdated: Sep 22, 2025
Eligibility criteria

Patients diagnosed with stress urinary incontinence. [+3]

Patients with concomitant neurological disorders, urinary tract infections, prio... [+13]

Status: Not yet recruiting

Effect of Knack Pelvic Floor Contraction on Sexual Dysfunction

This study aims to investigate the effect of knack pelvic floor contraction on sexual dysfunction in females with stress urinary incontinence.

Participants needed: 40
Trial details
Age: 25-45Biological sex: FemaleType: InterventionalSponsor: Cairo UniversityUpdated: Aug 28, 2025Locations: 1
Eligibility criteria

Females with mild and moderate degrees of SUI according to Incontinence Severity... [+5]

Severe degree of SUI. [+5]

Status: Recruiting

Managing Impact-related Leakage During Exercise Using Intravaginal Support

The goal of this study is to evaluate the effectiveness of using a regular menstrual tampon or a Uresta pessary to reduce urine leakage associated with running-induced stress urinary incontinence (RI-SUI) in females aged 18 and older. Secondly, the study aims to assess whether either intervention mitigates transient changes in pelvic morphology that occur following a single running bout. Lastly, we aim to evaluate whether participants continue using either intervention during running over the 4-week period following their in-lab participation. The hypotheses are: Hypothesis 1: Among females with RI-SUI, both a tampon and pessary used during a single running bout will reduce urinary leakage symptoms, with greater symptom reduction observed when using the pessary. Hypothesis 2: Participants will report high satisfaction and perceived symptom improvement with both the tampon and pessary, with higher satisfaction and greater improvement reported for the pessary. Hypothesis 3: Both the tampon and pessary will reduce pelvic floor strain incurred by the end of the run, as evidenced by less bladder neck descent, levator plate lengthening, and levator hiatus area increasing relative to that observed when no tampon or pessary is used. Hypothesis 4: A greater proportion of participants will report continued use of the pessary compared to the tampon over the 4-week post-lab period, with higher frequency of use and fewer reported discontinuations. We will perform within-subject comparisons against baseline values to determine the effect of each intervention on RI-SUI symptoms and pelvic organ support. Participants will complete a baseline questionnaire to collect demographic information and assess incontinence severity. They will then attend three laboratory visits within a 10-day period. At each visit, bladder volume will be standardized to between 100 and 200mL, then the participant will undergo three-dimensional (3D) transperineal ultrasound imaging conducted in a standing position. Following imaging, participants will complete a treadmill protocol consisting of 25-minutes running at a moderately difficult pace (rated at 13 - 14 on the Borg Perceiver Rate of Exertion scale), followed by 5 minutes of running at a higher intensity pace. During the run, participants will be asked at 5 minute intervals whether they experienced any urine leakage and to report their perceived amount of leakage. The ultrasound image protocol will be repeated immediately after the run. Participants will be allowed to keep the pessary and will be contacted 4-weeks after the final visit to evaluate whether or not they continued use of a tampon or the pessary, and, if so, we will ask them to report their satisfaction with the intervention(s) they used.

Participants needed: 30
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of OttawaUpdated: Aug 5, 2025Locations: 1
Eligibility criteria

Age >18 years of age [+3]

No urine leakage in the first laboratory assessment (baseline / no intervention) [+6]

Status: Not yet recruiting

PFU vs. UDS in SUI

The goal of this observational stury is to test the diagnostic accuracy of Pelvic Floor Ultrasound in evaluating women with stress urinary incontinence compared to the reference standard Urodynamic Studies. The main question it aims to answer is: Is Pelvic floor ultrasound as accurate as urodynamic studies in diagnosis of stress urinary incontinence?

Participants needed: 50
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Ain Shams UniversityUpdated: May 20, 2025
Eligibility criteria

Aged ≥ 18 years

Medical history of neurological disorders, cognitive disorders, dementia, Alzhei... [+3]

Status: Recruiting

Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women

Strain elastography (SE) will be utilized as a non-invasive imaging technique to evaluate tissue elasticity and biomechanical properties in women with stress urinary incontinence (SUI) and in continent controls. The primary aim is to determine whether SE can detect differences in paraurethral tissue stiffness between these groups. Given the established role of tissue elasticity in the pathophysiology of SUI, SE will be investigated as a potential diagnostic tool in urogynecological evaluations. This prospective cohort study will be conducted at a tertiary referral center. All participants will undergo introital two-dimensional (2D) ultrasound in the midsagittal plane at rest. SE will be performed in three predefined suburethral regions of interest (ROIs): * internal urethral orifice (IUO) level * midurethra (MU) level * external urethral orifice (EUO) level The adipose layer (AL) between the external urethral meatus and the pubic symphysis will serve as the reference tissue, representing the softest anatomical structure in the region. Descriptive and comparative statistical analyses will be conducted to assess differences in paraurethral tissue stiffness between the study groups. It is hypothesized that SE will be able to detect differences in paraurethral tissue elasticity, with SUI being associated with increased tissue compliance. The study also aims to determine whether SE can reliably distinguish between varying degrees of tissue stiffness in women with SUI and continent controls. Pathophysiological focus: The study will explore key mechanisms underlying SUI, including: * Weakened bladder neck support * Impaired urethral stabilization due to increased tissue elasticity and collagen degradation * While conventional 2D ultrasound provides anatomical information, it does not directly evaluate tissue biomechanics. In contrast, SE enables real-time visualization of tissue elasticity, offering a promising adjunct to traditional urogynecological assessment methods. Standardization and Protocol The study will follow a standardized protocol to ensure reproducibility and high-quality data. Key methodological elements include: * Minimal probe compression during introital ultrasound to avoid artifacts * Bladder emptying prior to examination to eliminate confounding effects * Carefully standardized ROI placement across all patients * Controlled image acquisition conditions to reduce variability Future Directions * Future research based on this study will aim to: * Optimize SE protocols and refine ROI placement strategies * Establish clinical cutoff values for differentiating tissue stiffness in SUI vs. continent women * Assess the long-term effects of pelvic floor muscle training (PFMT) and vaginal estrogen therapy on paraurethral biomechanics * Facilitate the integration of SE into routine urogynecological practice to support early diagnosis and personalized treatment strategies for SUI

Participants needed: 80
Trial details
Age: 18-99Biological sex: FemaleType: ObservationalSponsor: Szeged UniversityUpdated: Apr 18, 2025Locations: 1
Eligibility criteria

Clinical diagnosis of stress urinary incontinence (SUI) based on patient history...

Pelvic malignancy or history of pelvic radiation therapy [+7]

Status: Not yet recruiting

Long-term Evaluation of the I-STOP Sling in Stress Urinary Incontinence Treatment

Evaluate quality of life and rate of reoperation after implantation of the I-STOP sling for stress urinary incontinence

Participants needed: 500
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: DILO MedicalUpdated: Oct 30, 2024Duration: 10 Years
Eligibility criteria

Adult woman aged over 18 ; [+5]

Minor patient, pregnant or breastfeeding ; [+3]