Evaluating tests to detect complications in incontinence surgeries
Official title: Comparison of Complications Detected by Perioperative Cystoscopy Combined With Methylene Blue Test and Postoperative Cystoscopy in TVT and TOT Operations
Run by Gaziosmanpasa Research and Education Hospital · NCT06801938 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | Women only |
| Enrollment | 58 (estimated) |
| Sponsor | Gaziosmanpasa Research and Education Hospital Government |
| Locations | 1 site (Istanbul) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | June 1, 2025 |
| Study ends | January 1, 2026 |
| Registry record updated | February 6, 2025 |
| Trial ID | NCT06801938 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 85 with stress urinary incontinence who meet specific health criteria.
✕Probably not a fit
Patients with active cardiac disease, connective tissue disorders, or those with a BMI over 30 may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While similar approaches have been explored, this specific combination of tests in the context of TVT and TOT procedures is relatively novel.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.