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New treatment option for Stress Urinary Incontinence
Official title Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery
ClinicalTrials.gov ID: NCT06924450
What this study is testing
- What it's testing
- This study is a single-blind, randomized controlled trial evaluating whether changing the width of the surgical tape (mesh) used in transobturator tape (TOT) surgery improves treatment results in women with stress urinary incontinence (SUI). Two mesh widths are being compared: a 1.2 cm mesh (new method) and a 1.0 cm mesh (standard method).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female patients aged 18 years or older
- Clinical diagnosis of stress urinary incontinence (SUI), confirmed by:
- Positive stress test (urine leakage on coughing with a comfortably full bladder)
- Q-tip test showing urethral hypermobility (\>30 degrees)
- Inadequate response to conservative therapy (e.g., pelvic floor muscle training, behavioral therapy)
You likely can't join if
- History of prior midurethral sling surgery
- Mixed urinary incontinence or urge-dominant symptoms
- Pelvic organ prolapse stage \> II according to the POP-Q system
- Neurological disorders affecting bladder function (e.g., multiple sclerosis, spinal cord injury)
- Active urinary tract infection or recurrent UTI (defined as ≥3 infections within the past 12 months)
- Pregnant or planning to become pregnant within the next 12 months
See the full eligibility criteria
- Female patients aged 18 years or older
- Clinical diagnosis of stress urinary incontinence (SUI), confirmed by:
- Positive stress test (urine leakage on coughing with a comfortably full bladder)
- Q-tip test showing urethral hypermobility (\>30 degrees)
- Inadequate response to conservative therapy (e.g., pelvic floor muscle training, behavioral therapy)
- Eligible for transobturator tape (TOT) surgery
- Body mass index (BMI) less than 35 kg/m²
- Able to provide informed consent and follow postoperative instructions
- History of prior midurethral sling surgery
- Mixed urinary incontinence or urge-dominant symptoms
- Pelvic organ prolapse stage \> II according to the POP-Q system
- Neurological disorders affecting bladder function (e.g., multiple sclerosis, spinal cord injury)
- Active urinary tract infection or recurrent UTI (defined as ≥3 infections within the past 12 months)
- Pregnant or planning to become pregnant within the next 12 months
- Severe comorbid conditions (e.g., uncontrolled diabetes mellitus, active malignancy, pelvic radiotherapy)
- Use of medications that significantly affect bladder function (e.g., anticholinergics, diuretics)
- Inability or unwillingness to attend follow-up visits or comply with postoperative care plan
The study team makes the final eligibility decision.
Where it's taking place
- Van, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Van, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.