Surgical management for stress urinary incontinence using suburethral slings
Prospective, Non-Randomized, Observational Trial of the Surgical Management for Suburethral Slings in Women With Stress Urinary Incontinence
This study is testing how well a suburethral sling surgery works for people with stress urinary incontinence and how it affects their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cantonal Hospital, Frauenfeld Academic / other |
| Locations | 1 site (Frauenfeld, Thurgau) |
| Trial ID | NCT02785016 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with surgically-correctable stress urinary incontinence who will undergo a suburethral sling procedure. It collects preoperative urologic testing data, medical history, and quality of life questionnaires from participants. Intraoperative data will also be gathered, and postoperative outcomes will be assessed through follow-up questionnaires and ultrasound testing to evaluate the device's position. The study aims to provide insights into the effectiveness and safety of this surgical approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with demonstrable signs of stress urinary incontinence.
Not a fit: Patients with neurological diseases, active perineal injuries, urethral obstructions, significant pelvic organ prolapse, or urinary tract infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and quality of life for patients suffering from stress urinary incontinence.
How similar studies have performed: Other studies have shown positive outcomes with similar surgical approaches for stress urinary incontinence, indicating a potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with intrinsic sphincter deficiency (ISD). Objective testing includes: standing stress test, urodynamics evaluation, or pad test. 2. Patient is age 18 or older. 3. Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the IRB/EC-approved informed consent. 4. Patient is able to fill in all questionnaires (on judgement of investigator) Exclusion Criteria: 1. Patient has an associated or suspected neurological disease. 2. Patient has an active lesion or present injury to perineum or urethra. 3. Patient has a urethral obstruction. 4. Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment. 5. The subject has current urinary tract infection.
Where this trial is running
Frauenfeld, Thurgau
- Blasenzentrum, Cantonal Hospital — Frauenfeld, Thurgau, Switzerland (Recruiting)
Study contacts
- Principal investigator: Volker Viereck, Physican — Cantonal Hospital, Frauenfeld
- Study coordinator: Volker Viereck, Physican
- Email: volker.viereck@stgag.ch
- Phone: ++41 52 723 70 50
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.