Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT06924450
Eligibility Criteria:
Inclusion 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06924450
Study Brief:
Protocol Section:
NCT06924450