Evaluating the effectiveness and safety of a midurethral sling for urinary incontinence
Evaluation of Efficacy and Safety of Midurethral Slings in Women With Stress Incontinence
This study is testing if a new surgical treatment for stress urinary incontinence helps improve bladder function and is safe for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 30 Years to 100 Years |
| Sex | Female |
| Sponsor | Mackay Medical College Academic / other |
| Locations | 1 site (New Taipei City) |
| Trial ID | NCT05255289 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of the trans-obturator tape (TOT) as a surgical treatment for stress urinary incontinence (SUI). It involves a retrospective analysis of urodynamic parameters before and after the TOT procedure, including free uroflowmetry, postvoid residual, filling and voiding cystometry, and urethral pressure profile. The aim is to determine whether the bladder's voiding function is affected by the increased outlet resistance provided by the TOT. Data will be analyzed using statistical methods to assess differences in urodynamic measurements over time.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with stress urinary incontinence who have undergone urodynamic evaluations before and after surgery.
Not a fit: Patients with a history of cardiovascular, neurological, or other significant medical conditions, as well as those who have had concurrent surgical procedures, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes for patients with stress urinary incontinence by providing insights into bladder function post-surgery.
How similar studies have performed: Other studies have shown promising results with similar surgical approaches for treating stress urinary incontinence, indicating a potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of stress urinary incontience * Have urodynamic investigations before and after operation. Exclusion Criteria: * Exclusion criteria will be a history of (1) cardiovascular, (2) neurological, or (3) other medical (such as diabetes or inflammation) problems as well as (4) patients who received a concomitant surgical procedure.
Where this trial is running
New Taipei City
- Department of Obstetrics and Gynecology — New Taipei City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Hui-Hsuan Lau, M.D.
- Email: huihsuan1220@gmail.com
- Phone: +886-975-835928
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.