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临床试验/NCT07290114
NCT07290114招募中不适用

Mesh-Free Versus Mesh-Based Surgery for Female Stress Urinary Incontinence: A Prospective Comparison of Pubo-Urethral Ligament Plication and Transobturator Tape With Short-Term Patient-Centered Outcomes

Mehmet Incebıyik2 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2025年1月13日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
147
试验地点
2
主要终点
Improvement in Stress Urinary Incontinence Symptoms (ICIQ-SF Score)

研究概览

简要总结

This prospective clinical study aims to compare the short-term effectiveness, safety, and patient-reported outcomes of two surgical techniques used for the treatment of female stress urinary incontinence (SUI): Pubo-Urethral Ligament Plication (PLP), a mesh-free native tissue repair method, and the Transobturator Tape (TOT) procedure, a commonly used mesh-based mid-urethral sling technique. The study evaluates continence improvement, perioperative and postoperative complications, operative time, hospital stay, postoperative pain, and patient satisfaction. The goal is to provide evidence on whether a mesh-free surgical option such as PLP can offer comparable outcomes to mesh-based TOT, particularly for patients seeking alternatives to synthetic materials.

详细描述

This is a single-center, prospective, comparative clinical study evaluating two established surgical interventions for female stress urinary incontinence (SUI): Pubo-Urethral Ligament Plication (PLP) and Transobturator Tape (TOT). PLP is a mesh-free native tissue repair technique that reinforces pubo-urethral support by plicating the periurethral tissues. TOT, a mesh-based mid-urethral sling procedure, provides support to the urethra through the placement of a synthetic tape via the transobturator route.

Eligible patients with a clinical diagnosis of SUI who elect to undergo surgical treatment will be allocated to one of the two interventions based on shared decision-making between the surgeon and the patient. The study will collect demographic data, operative parameters, perioperative complications, and short-term postoperative outcomes. Continence outcomes will be assessed using validated questionnaires such as the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), as well as objective clinical evaluation during follow-up visits. Pain levels, urinary retention, de-novo urgency, wound complications, and overall patient satisfaction will also be recorded.

The primary aim of the study is to compare early continence improvement between the PLP and TOT procedures. Secondary aims include comparing perioperative and postoperative complications, operative time, postoperative pain, hospital discharge time, and patient-reported satisfaction. By directly comparing a mesh-free native tissue technique with a commonly used mesh-based sling, this study seeks to provide updated, patient-centered data that may guide surgical decision-making, especially in settings where mesh-related concerns or patient preference favor native tissue repair options.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients aged 18-80 years
  • Clinical diagnosis of stress urinary incontinence
  • Failure of conservative management (pelvic floor exercises or medical therapy)
  • Desire to undergo surgical treatment (PLP or TOT)
  • Ability to provide informed consent
  • Willingness to attend postoperative follow-up visits

排除标准

  • Mixed urinary incontinence with predominant urge symptoms
  • Active urinary tract infection
  • Pelvic organ prolapse ≥ stage II
  • Previous anti-incontinence surgery
  • Neurological diseases affecting bladder function
  • Pregnancy or planning pregnancy during follow-up
  • Uncontrolled diabetes, bleeding disorders, or contraindications to surgery
  • Use of medications affecting bladder function (e.g., anticholinergics)
  • Inability to provide informed consent

结局指标

主要结局

Improvement in Stress Urinary Incontinence Symptoms (ICIQ-SF Score)

时间窗: 6-24 weeks postoperatively

Change in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score from baseline to postoperative 6 weeks. Lower scores indicate improvement in symptom severity.

次要结局

未报告次要终点

研究者

发起方
Mehmet Incebıyik
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mehmet Incebıyik

Assistant Professor of Obstetrics and Gynecology

Harran University

研究点 (2)

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