Short-Term Outcomes of TOT, TVT, and Burch Surgery Assessed by Transperineal Ultrasound (NCT07312617) | Clinical Trial Compass
CompletedNot Applicable
Short-Term Outcomes of TOT, TVT, and Burch Surgery Assessed by Transperineal Ultrasound
Turkey (Türkiye)80 participantsStarted 2023-04-01
Plain-language summary
Stress urinary incontinence is a common condition in women and is often treated with surgical procedures such as transobturator tape (TOT), tension-free vaginal tape (TVT), and Burch colposuspension. Although these procedures are widely used, there is limited information comparing their short-term anatomical and patient-reported outcomes using imaging techniques.
The aim of this study is to compare the short-term anatomical and subjective outcomes of TOT, TVT, and Burch colposuspension in women with stress urinary incontinence. Transperineal ultrasonography will be used to assess anatomical changes before surgery and during follow-up. Patient-reported outcomes and clinical findings will also be evaluated.
The results of this study may help improve the understanding of surgical outcomes in stress urinary incontinence and support clinical decision-making.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patients aged 18 years or older
* Diagnosis of stress urinary incontinence based on clinical evaluation
* Candidates for surgical treatment with transobturator tape (TOT), tension-free vaginal tape (TVT), or Burch colposuspension
* Ability to provide written informed consent
* Willingness to participate in the study and comply with follow-up visits
Exclusion Criteria:
* Mixed or urge-predominant urinary incontinence
* Previous anti-incontinence or pelvic floor surgery
* Neurogenic bladder disorders
* Active urinary tract infection at the time of evaluation
* Pregnancy or planned pregnancy during the study period
* Known pelvic malignancy
* Inability to undergo transperineal ultrasonographic evaluation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Urethrovesical and Urethral Angles Assessed by Transperineal Ultrasound
Timeframe: Baseline (preoperative) and 3 months postoperatively
Trial details
NCT IDNCT07312617
SponsorZeynep Kamil Maternity and Pediatric Research and Training Hospital