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临床试验/CTRI/2024/10/074973
CTRI/2024/10/074973
尚未招募
4 期

A Comparative Analysis Of Perioperative And Functional Outcome Of Autologus Rectus Fascia Sling Vs Fascia Lata Sling In The Surgical Management Of Stress Urinary Incontinence

Institute based research1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月21日最近更新:

概览

阶段
4 期
状态
尚未招募
发起方
Institute based research
入组人数
30
试验地点
1
主要终点
Efficacy of two surgical procedures for cure of SUI

概览

简要总结

This study is to compare the surgical outcome as well as the   perioperative   and    post-operative   complications, that arise from using autologous fascia harvested from either the rectus fascia or the fascia lata. The purpose of this  comparison  is  to  determine success rate of both surgery and which  harvest  site has lower complication rates. By analyzing and evaluating these outcomes, we hope to provide valuable insights into the most    effective     and     efficient    methods     of     using autologous   fascia   in   surgical    management   of    SUI. Ultimately, our goal is to improve patient outcomes and reduce  complication  rates  by  identifying  the  optimal harvest site for autologous fascia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
25.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Women with proven stress urinary incontinence
  • No symptom relief after PFMT( pelvic floor muscle training)
  • Written informed consent.

排除标准

  • Previous surgeries for incontinence or prolapse
  • Concomitant vaginal prolapse greater than stage 2 according to POP Q System
  • Uncontrolled overactive bladder symptoms
  • Neurological diseases like Parkinson’s disease, multiple sclerosis
  • Bleeding diathesis.

结局指标

主要结局

Efficacy of two surgical procedures for cure of SUI

时间窗: 6 weeks , 6 months

次要结局

  • 1. Postoperative complications like blood loss, length of hospital stay, wound complication like infection or ,Sedona formation, readmission, PVR VOLUME, URINARY RETENTION AND NEED For catheterisation or de novo urinary complaint(2. To assess difficulty in daily activities via functional pain assessment score)

研究者

发起方
Institute based research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr J B Sharma

AIIMS New Delhi

研究点 (1)

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