Clinical trial NCT06924450: Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery
Official title: Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Female Urinary Incontinence
Pelvic Floor Dysfunction
Keywords: Urinary Incontinence
Stress Urinary Incontinence (SUI)
Female Pelvic Health
Transobturator Tape (TOT) Procedure
Pelvic Floor Surgery
Surgical Mesh
Randomized Controlled Trial
Urogynecology
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized, single-blind parallel-group study compares the surgical outcomes of two mesh widths (1.2 cm vs. 1.0 cm) used in transobturator tape (TOT) surgery for women with stress urinary incontinence (SUI).
Primary purpose: TREATMENT

Brief summary: 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). The main goal is to find out if the wider mesh leads to better urinary control and fewer complications. Participants will be followed for one year to measure cure rates, symptom improvement, and satisfaction.

Detailed description: This is a prospective, single-blind, randomized controlled trial evaluating the effect of mesh width on surgical outcomes in transobturator tape (TOT) procedures for women with stress urinary incontinence (SUI). A total of 106 participants will be randomized using a computer-generated allocation into two groups receiving either a 1.2 cm mesh (intervention group) or a 1.0 cm mesh (standard procedure).

The procedures will be conducted by a single experienced surgeon using a monofilament polypropylene mesh to ensure standardization. Surgical technique, anesthesia protocols, and perioperative management will be identical in both groups.

Primary outcome is objective cure, defined as negative stress test at 6 months. Secondary outcomes include symptom improvement (ICIQ-SF), mesh-related complications (erosion, infection, retention), and patient satisfaction assessed via structured Likert survey.

Follow-up visits are scheduled at 1 week, 1 month, and 1 year. Postoperative assessments will be conducted by a blinded evaluator. The study aims to evaluate whether wider mesh width provides superior anatomical support and reduces complication rates in comparison to standard mesh.

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

Primary outcomes:
measure: Objective Cure Rate Based on Negative Stress Test
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Change in ICIQ-SF Score
timeFrame: 6 months postoperatively
measure: Incidence of Mesh-Related Complications
timeFrame: 6 months postoperatively
measure: Recurrence of Stress Urinary Incontinence
timeFrame: 6 months postoperatively
measure: Patient Satisfaction Score
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Regional Training and Research Hospital, Department of Obstetrics and Gynecology
Study officials:
References: