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66 active trials for Stress Urinary Incontinence

Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.

Start: January 2015

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.

Start: December 2019

Adaptive Design Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair

This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) compared to a placebo in the treatment of stress urinary incontinence (SUI) in adult female patients. Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.

Start: April 2019

Mesh-free Suture Urethropexy for Treating Stress Urinary Incontinence, Efficacy and Durability Trial

In this proposed study, the investigators aim to evaluate a modified suture urethropexy technique for the treatment of female stress urinary incontinence. Participants will be followed with postoperative visits after 2 weeks, 2 months, and 12 months. Pelvic floor ultrasound imaging will be performed before surgery and after 2 months and 12 months, to evaluate urethral mobility.

Start: May 2021

Pessary Use for Stress Urinary Incontinence in Pregnancy

When women are pregnant they are more likely to leak urine which can severely affect their quality of life. This problem could be fixed by using a pessary. A pessary is a silicone ring that goes into the vagina which can stop or improve urinary leakage. These devices have been safely used for hundreds of years. However, pessaries has not been studied for urinary leakage in pregnancy. The investigators would like to compare severity of urinary leakage using a number of questionnaires during the last 3 months of pregnancy for women using a pessary versus women without a pessary.

Start: February 2021

Artificial Urinary Sphincter Clinical Outcomes

To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.

Start: October 2019

Vesair Clinical Trial

Single-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women

Start: February 2020

Study Electromyographic Activity of the Muscles of the Pelvic Floor Runners With Conventional Shoes and Minimalist.

JUSTIFICATION: Urinary incontinence is highly prevalent among women who play high impact sports such as running. that observed one of the possible reasons for this high prevalence is delayed activation of the pelvic floor in relation to the abdominal muscles. The use of minimalist shoes during the race produces changes in muscle and joint biomechanics and efficiency in the race. However, to date no studies evaluating the influence of footwear in the musculature of the pelvic floor during the race. OBJECTIVE: Describe and compare the electromyographic activity of the muscles of the pelvic floor and abdominal during the race with conventional shoes and minimalist. DESIGN: cross-over study experimental, analytical and prospective. METHODOLOGY: conventional and minimalist: 10 healthy young women, randomized into two groups to characterize the electromyographic activity of the muscles of the pelvic floor prior and during the race at 9 km / h with the two types of slippers are included. an initial assessment in which it is confirmed that women meet the criteria for inclusion and exclusion will be made. the ability to run will be assessed a 10-minute treadmill at a speed of 9-13 km / h as well as the ability to properly contract the muscles of the pelvic floor. The first group will race with conventional shoes and then minimal, while the second group will make the race with minimalist and after conventional shoes. Both groups have a washout period of 10 minutes between both interventions. EMG recording are collect with electromyographic sensors musculature of the pelvic floor (by intravaginal probe germproof brand), abdominal (intern and oblique external oblique), erector spinae and gluteal (by surface sensor) in relation to the cycle gear, barographic recorded with sensors. The variables to be included in the electromyography for each muscle regarding the gait cycle will be, activation start, duration, intensity and synergy with its corresponding standard deviation.

Start: February 2021

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).

Start: May 2021

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.

Start: May 2021

Post-Market Clinical Follow-Up onTVT EXACT® Continence System

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

Start: May 2021

ProACT Post-Approval Study

The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies.

Start: February 2019

Pelvic Floor Muscles and Success in the Surgical Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse

The aim of the study is evaluation of the efficiency of pelvic floor muscles in the context of surgical outcomes in the treatment of stress urinary incontinence and pelvic organ prolapse.

Start: August 2019

The Effect of Mid-urethral Sling on the Urethral Dynamic Shape and Motion

The purpose of this prospective cohort study is to investigate the effect of sling on urethral dynamic shape and motion using static and dynamic pelvic floor ultrasound and additionally compare the findings among women with successful vs failed surgical outcome.

Start: January 2021

IUL Study A Randomized Sham - Controlled Clinical Study

Primary aim of the study is to compare the impact of SUI on the VAS (visual analogue scale) 3 months after laser therapy versus sham laser therapy.

Start: January 2021

Safety and Clinical Performance Study of the ARTUS MONO Artificial Urinary Sphincter (AUS)

This clinical investigation is designed as an interventional, prospective, non-randomized, open-label, single arm, multicentric and international study for obtaining CE marking. The study will be the first performed with the ARTUS MONO AUS medical device aiming to assess safety and performance and will be composed of three phases: pilot phase (with safety analysis on the 10 first included subjects in 3 investigational sites), pivotal phase (in up to 7 investigational sites with a follow-up until the 12-month post-device activation visit, including an interim analysis at 3-month post-device activation visit on performance and safety), long-term phase (with a long-term follow-up until 10 years post implantation in up to 7 investigational sites). The objectives is to assess safety and clinical performance of the ARTUS MONO AUS for the treatment of Stress Urinary Incontinence at short and long-term.

Start: June 2021

Erbium Vaginal Laser for the Treatment of Stress Urinary Incontinence

Two arms of women who suffer from clinical stress urinary incontinence. Women will be divided randomly into two arms. One arm will be treated with vaginal Erbium laser and the second with Sham laser, three treatments each. Follow up will be done 6 and 12 months after the last treatment.

Start: March 2021

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.

Start: May 2021

Yoga-Pilates Exercise & the Effects on Urethral Rhabdosphincter Morphology and Stress Urinary Incontinence

This is a prospective interventional study conducted at Oregon Health & Science University that will measure the pre- and post-intervention characteristics of women with stress urinary incontinence undergoing an 8-week home yoga-Pilates intervention. The investigators plan to deliver this method of exercise to patients through a web-based video in order to increase accessibility and compliance and decrease patient costs. The investigators will assess changes using a pre- and post-treatment 1-day voiding diary, answers to questionnaires International Consultation on Incontinence Questionnaire-Short Form and Patient Global Impression of Improvement questionnaire), transperineal ultrasound, and physical exam.

Start: October 2020

Prospective Study of the sensiTVT

sensiTVT is a relatively new tape. The aim of this study is to analyze the objective and subjective outcome at one year follow-up.

Start: October 2018