Evaluating tests to detect complications in incontinence surgeries
Comparison of Complications Detected by Perioperative Cystoscopy Combined With Methylene Blue Test and Postoperative Cystoscopy in TVT and TOT Operations
NA · Gaziosmanpasa Research and Education Hospital · NCT06801938
This study is testing whether a new way of checking for problems during incontinence surgery can find issues earlier than the usual method, helping patients have better outcomes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Gaziosmanpasa Research and Education Hospital (other gov) |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06801938 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of perioperative cystoscopy combined with a methylene blue test against postoperative cystoscopy in identifying complications during tension-free vaginal tape (TVT) and transobturator tape (TOT) procedures for treating stress urinary incontinence. Participants will undergo these tests to assess their ability to detect complications that may arise during surgery. The study aims to improve surgical outcomes by identifying issues early in the perioperative period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with stress urinary incontinence who meet specific health criteria.
Not a fit: Patients with active cardiac disease, connective tissue disorders, or those with a BMI over 30 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better detection of complications during incontinence surgeries, improving patient safety and outcomes.
How similar studies have performed: While similar approaches have been explored, this specific combination of tests in the context of TVT and TOT procedures is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Providing consent to participate in the study * Being between the ages of 18 and 85 * Having stress urinary incontinence * No active cardiac disease * No connective tissue disorders (e.g., Marfan syndrome) * No known gynecological malignancy * BMI under 30 * No chronic constipation * No inflammatory bowel disease Exclusion Criteria: * Not providing consent to participate in the study * Being under 18 or over 85 years old * Not having stress urinary incontinence * Having active cardiac disease * Having connective tissue disorders (e.g., Marfan syndrome) * Having a known gynecological malignancy * Having a BMI over 30 * Having chronic constipation * Having inflammatory bowel disease
Where this trial is running
Istanbul
- Gaziosmanpaşa Training and Research Hospital — Istanbul, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Fatma Ketenci Gencer, Associate Professor
- Email: fathma_k@hotmail.com
- Phone: +905416116469
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.
Conditions: Incontinence Stress, tvt, tot, cystoscopy