View clinical trials related to Stress Urinary Incontinence.
Filter by:The purpose of this trial was to discover which type of operation for stress urinary incontinence in women offered better results: autologous slings, TVT or Pelvicol slings.
Urinary incontinence which is a major health issue in women affects 30-40% of older women. Surgical treatments for SUI have undergone many modifications in the last century. The Needleless Sling System is a one incision, minimally invasive, surgical procedure that has had great acceptance in Europe and has recently received FDA Clearance for use in the United States. We will evaluate effectiveness and patient reported outcomes for Needleless® sling system (Neomedic International). This is a prospective, multicenter, registry. Up to 150 women will be enrolled from up to 3 registry sites. Patients will be evaluated at baseline, peri-operatively, and post-operatively up to 2 months, up to 6 months and at 12 months. Effectiveness evaluations will include a standing stress test (objective cure), SANDVIK questions (subjective cure) & I-QOL (quality of life measure). Other evaluations will include type of anesthesia, concurrent surgery, operative time, post-operative pain, length of hospital stay, returning to usual activities, change of lower urinary tract symptoms (BFLUTSSF, voiding diaries), goal achievement and patient satisfaction.
Midurethral tapes are by now standard procedure in the surgical treatment of women with stress urinary incontinence. While the retropubic TVT is well documented with long-term results up to 11 years and continence rates of 90 %, the published data for the transoburator tapes (TO) cover follow-up of 3 years only. So far, all tapes establish continence effectively. Recently, the detailed 27-item Incontinence Outcome Questionnaire (IOQ) was constructed to assess patient-reported outcome and quality of life after insertion of a midurethral tape and validated for the German language. The aim of this study was to evaluate patient-reported mid- and long-term outcome after insertion of tension-free vaginal tape (TVT), transobturator sling, outside-in (TOT) and tension-free transobturator tape, inside-out (TVT-O).
The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the treatment of the condition of stress urinary incontinence
This is a prospective, non-randomized, observational, multicentre (5 sites) study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a TVT SECUR operative procedure. The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires, Intraoperative procedural data will be collected. Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals up to 24 months. The anatomic position of the device will be characterize by transvaginal ultrasound testing. To determine the rate and/or improvement rate of patients who have received the Gynecare Secur device after 12 months and after 24 months.
The Autologous Cell Therapy for Female SUI study is a clinical trial to determine the safety and potential effectiveness of a single dose of 200 million Cook MyoSite Autologous Muscle Derived Cells for treatment of Stress Urinary Incontinence.
A prospective, multi-center study of the AdVance Male Sling for Stress Urinary Incontinence. The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication. This study is not designed to statistically demonstrate safety and efficacy of the device.
The purpose of this study is to assess the delay between the detection (by mechanomyography-MMG) of rectus abdominis contraction and the detection of cough in cough effort.
This study is a multi-center, global study that will assess the effectiveness and patient satisfaction of the male incontinence sling 12 months after implant as well as the safety profile of the product.
This is a clinical investigation approved by US FDA and Canadian Health Authority to study the safety and potential effectiveness of the autologous muscle cells for the treatment of stress urinary incontinence.