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

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.

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence; Pelvic Floor Dysfunction; Female Urinary Incontinence
• Intervention / Treatment: Device: 1.2 cm Mesh TOT; Device: 1.0 cm Mesh TOT

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.

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yusuf Başkıran, Doctor; Phone Number: +905419523468; Email: yusuf.baskiran@istinye.edu.tr

Study Locations

• Turkey
  • Van, Turkey, 65090
    • Recruiting
    • Van Regional Training and Research Hospital, Department of Obstetrics and Gynecology
    • Contact: Yusuf Başkıran, MD; Phone Number: +90 432 215 76 02; Email: yusuf.baskiran@istinye.edu.tr
    • Principal Investigator: Yusuf Başkıran, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1.2 cm Mesh (Intervention Group); Participants in this group will undergo transobturator tape (TOT) surgery using a 1.2 cm monofilament polypropylene mesh.	Device: 1.2 cm Mesh TOT; Patients in this group will undergo transobturator tape (TOT) surgery using a 1.2 cm monofilament polypropylene mesh. The modified mesh width is being evaluated for its effect on surgical success, symptom improvement, and postoperative complications.
Active Comparator: 1.0 cm Mesh (Control Group); Participants in this group will undergo transobturator tape (TOT) surgery using a 1.0 cm monofilament polypropylene mesh, which represents the standard procedure.	Device: 1.0 cm Mesh TOT; Patients in this group will undergo transobturator tape (TOT) surgery using a 1.0 cm monofilament polypropylene mesh, which is the standard procedure. This group serves as a comparator to assess the impact of the modified mesh width.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Cure Rate Based on Negative Stress Test	Objective cure will be defined as the absence of urinary leakage during a standardized cough stress test with a comfortably full bladder. The test will be performed by a blinded assessor at 6 months postoperatively.	6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Mesh-Related Complications	Incidence of mesh-related complications including mesh erosion, bladder outlet obstruction, infection, and pain. Complications will be assessed by physical examination and patient-reported symptoms during follow-up visits.	6 months postoperatively
Recurrence of Stress Urinary Incontinence	Proportion of patients who present with recurrence of stress urinary incontinence, defined as a positive cough stress test or self-reported symptoms of urine leakage during physical activity. Time Frame: 6 months postoperatively	6 months postoperatively
Change in ICIQ-SF Score	Change in total score on the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), measured before surgery and at 6 months postoperatively. The ICIQ-SF ranges from 0 to 21, with higher scores indicating worse symptom severity and greater impact on quality of life.	6 months postoperatively
Patient Satisfaction Score	Patient satisfaction will be measured using a structured questionnaire that includes a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction. Assessment will be conducted at the 6-month follow-up visit.	6 months postoperatively

Collaborators and Investigators

• Sponsor: Izzet Celegen

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Estimated): November 12, 2025
• Study Completion (Estimated): November 12, 2025

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Urinary Incontinence; Urogynecology; Surgical Mesh; Female Pelvic Health; Stress Urinary Incontinence (SUI); Transobturator Tape (TOT) Procedure; Pelvic Floor Surgery
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: YB-MESH-2025-VAN001; EK-090523 (Other Identifier: Van Regional Training and Research Hospital Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data (IPD) will not be shared due to confidentiality policies and institutional regulations. Summary-level results may be shared upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No