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Clinical Trials/CTRI/2025/09/093954
CTRI/2025/09/093954
Not yet recruiting
Phase 3

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 site in 1 country40 target enrollmentStarted: September 9, 2025Last updated:

Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Leela Madhav Panugothu
Enrollment
40
Locations
1
Primary Endpoint
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

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: at 3 months and 6 months post surgery

Secondary Outcomes

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

Investigators

Sponsor
Leela Madhav Panugothu
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Leela Madhav Panugothu

AIIMS, Jodhpur

Study Sites (1)

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