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临床试验/CTRI/2025/09/093954
CTRI/2025/09/093954尚未招募3 期

The Use of Autologous Platelet-Rich Plasma Gel in Urethral Stricture Disease Undergoing Buccal Mucosal Graft Urethroplasty: An Open-Labelled Parallel Randomized Controlled Trial

Leela Madhav Panugothu1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月9日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To compare effectiveness of treatment by using Validated symptom score (IPSS score) in patients undergoing Buccal Mucosal Graft Urethroplasty for Urethral stricture disease by using PRP in comparison to conventional Buccal Mucosal Graft Urethroplasty

研究概览

简要总结

This is an open-labeled parallel randomized controlled trial evaluating the efficacy of autologous platelet-rich plasma (PRP) gel in preventing recurrence of urethral strictures in patients undergoing buccal mucosal graft urethroplasty (BMGU). Urethral stricture, a narrowing of the urethra due to fibrosis, is treated with BMGU for strictures longer than 3 cm, with success rates of 85-95%. PRP, rich in growth factors, is hypothesized to reduce fibrosis and enhance healing. The study compares conventional BMGU with BMGU plus PRP injection, involving 40 patients per group. Patients over 18 with urethral strictures are included, excluding those with thrombocytopenia, coagulation disorders, recurrent strictures, or unfit for surgery. Outcomes include the International Prostate Symptom Score (IPSS), perioperative complications, and stricture recurrence rates, assessed over six months with follow-ups at three-month intervals. PRP is prepared from 8-10 ml of autologous blood, processed through centrifugation. Data will be analyzed using SPSS, with statistical significance set at p<0.05. The study aims to improve BMGU outcomes by reducing fibrosis-related recurrence.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with Urethral stricture disease undergoing Buccal Mucosal Graft Urethroplasty.

排除标准

  • a) Patient unfit for surgery/Anaesthesia.
  • b) Patients with thrombocytopenia c) Patients with coagulation disorders d) Patients not giving consent.

结局指标

主要结局

To compare effectiveness of treatment by using Validated symptom score (IPSS score) in patients undergoing Buccal Mucosal Graft Urethroplasty for Urethral stricture disease by using PRP in comparison to conventional Buccal Mucosal Graft Urethroplasty

时间窗: at 3 months and 6 months post surgery

次要结局

  • • To assess the perioperative complication rate in two groups
  • •To compare recurrence rate of stricture in two groups

研究者

发起方
Leela Madhav Panugothu
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Leela Madhav Panugothu

AIIMS, Jodhpur

研究点 (1)

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