Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery

NCT06924450 | Recruiting

• 2 other identifiers: YB-MESH-2025-VAN001EK-090523
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in ICIQ-SF Score

  6 months postoperatively

• Incidence of Mesh-Related Complications

  6 months postoperatively

• Recurrence of Stress Urinary Incontinence

  6 months postoperatively

• Patient Satisfaction Score

  6 months postoperatively

Study Arms (2)

1.2 cm Mesh (Intervention Group)

EXPERIMENTAL

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

Device: 1.2 cm Mesh TOT

1.0 cm Mesh (Control Group)

ACTIVE COMPARATOR

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

Interventions

1.2 cm Mesh TOT DEVICE

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.

1.2 cm Mesh (Intervention Group)

1.0 cm Mesh TOT DEVICE

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.

1.0 cm Mesh (Control Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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)
• Eligible for transobturator tape (TOT) surgery
• Body mass index (BMI) less than 35 kg/m²
• Able to provide informed consent and follow postoperative instructions

You may not qualify 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
• 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

Sponsors & Collaborators

• Izzet Celegen: lead

Study Sites (1)

Van Regional Training and Research Hospital, Department of Obstetrics and Gynecology

Van, 65090, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yusuf Başkıran, Doctor

CONTACT

+905419523468; yusuf.baskiran@istinye.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor evaluating postoperative results is blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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).

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: April 11, 2025
• Study Start: May 12, 2025
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)