Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery (MOTOT)

Izzet Celegen

Status: Enrolling

Conditions: Stress Urinary Incontinence; Pelvic Floor Dysfunction; Female Urinary Incontinence

Treatments: Device: 1.2 cm Mesh TOT; Device: 1.0 cm Mesh TOT

Study type: Interventional

Funder types: Other

Identifiers

NCT06924450

YB-MESH-2025-VAN001

EK-090523 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

1.2 cm Mesh (Intervention Group)

Experimental group

Description:

Participants in this group will undergo transobturator tape (TOT) surgery using a 1.2 cm monofilament polypropylene mesh.

Treatment:

Device: 1.2 cm Mesh TOT

1.0 cm Mesh (Control Group)

Active Comparator group

Description:

Participants in this group will undergo transobturator tape (TOT) surgery using a 1.0 cm monofilament polypropylene mesh, which represents the standard procedure.

Treatment:

Device: 1.0 cm Mesh TOT