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Идёт набор NCT06924450

Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery

Без фазы С лечением Stress Urinary Incontinence Female Urinary Incontinence Pelvic Floor Dysfunction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 1.2 cm Mesh TOT, 1.0 cm Mesh TOT.
Кому может быть актуально
Состояния в реестре: Stress Urinary Incontinence, Female Urinary Incontinence, Pelvic Floor Dysfunction. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство 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.
  • Устройство 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.

Первичные конечные точки

  • Objective Cure Rate Based on Negative Stress Test [Срок оценки: 6 months postoperatively]
Вторичные конечные точки (4)
  • Change in ICIQ-SF Score [Срок оценки: 6 months postoperatively]
  • Incidence of Mesh-Related Complications [Срок оценки: 6 months postoperatively]
  • Recurrence of Stress Urinary Incontinence [Срок оценки: 6 months postoperatively]
  • Patient Satisfaction Score [Срок оценки: 6 months postoperatively]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Van Regional Training and Research Hospital, Department of Obstetrics and Gynecology — Van

Идентификаторы

NCT: NCT06924450 · YB-MESH-2025-VAN001 · EK-090523

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗