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NCT Number: NCT06924450

Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Van, 65090, Turkey (Türkiye)

Location status: Recruiting

Location contact

Yusuf Başkıran, MD

CONTACT

[email protected]

+90 432 215 76 02

Yusuf Başkıran, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

1.0 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.

Primary outcomes

  1. Objective Cure Rate Based on Negative Stress Test

    Time frame: 6 months postoperatively

    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.

Secondary outcomes

  1. Change in ICIQ-SF Score

    Time frame: 6 months postoperatively

    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.

  2. Incidence of Mesh-Related Complications

    Time frame: 6 months postoperatively

    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.

  3. Recurrence of Stress Urinary Incontinence

    Time frame: 6 months postoperatively

    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

  4. Patient Satisfaction Score

    Time frame: 6 months postoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yusuf Başkıran, Doctor

CONTACT

[email protected]

+905419523468

Sponsors and collaborators

Lead sponsor

Izzet Celegen

Other

Registry information

Acronym: MOTOT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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