| CTRI Number |
CTRI/2025/09/093954 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Evaluating a Blood-Derived Gel to Improve Surgical Treatment of Urethral Narrowing Using Tissue from the Inner Cheek" |
|
Scientific Title of Study
|
The Use of Autologous Platelet-Rich Plasma Gel in Urethral Stricture Disease Undergoing Buccal Mucosal Graft Urethroplasty: An Open-Labelled Parallel Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Leela Madhav Panugothu |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, Jodhpur |
| Address |
OPD Room No - 545, c block, Department of Urolgy, AIIMS Basni(Phase II), Industrial area, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7702832455 |
| Fax |
|
| Email |
madhav.personal4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahendra Singh |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Jodhpur |
| Address |
OPD Room No - 545, c block, Department of Urolgy, AIIMS Basni(Phase II), Industrial area, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9891445049 |
| Fax |
|
| Email |
dr.mahi1118@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahendra Singh |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Jodhpur |
| Address |
OPD Room No - 545, c block, Department of Urolgy, AIIMS Basni(Phase II), Industrial area, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9891445049 |
| Fax |
|
| Email |
dr.mahi1118@gmail.com |
|
|
Source of Monetary or Material Support
|
| All india Institute of Medical Sciences, Jodhpur , Rajasthan, India. PIN: 342005 |
|
|
Primary Sponsor
|
| Name |
Leela Madhav Panugothu |
| Address |
OPD Room No - 545, c block, Department of Urolgy, AIIMS Basni(Phase II), Industrial area, Jodhpur, INDIA, Pin: 342005 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Leela Madhav Panugothu |
All India Institute of Medical Sciences |
Department of Urolgy, AIIMS Basni(Phase II), Industrial area, Jodhpur
Jodhpur
RAJASTHAN |
07702832455
madhav.personal4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Clinical trial), All India Institute of Medical Sciences (AIIMS) - Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N359||Urethral stricture, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autologus Paltelet Rich Plasma |
Blood was taken preoperatively and processed using standard protocols at our institute and placed at graft site during Buccal Mucosal Graft urethroplasty |
| Comparator Agent |
Patient undergoing Buccal Mucosal Graft urethroplasty without autologus Platelet Rich plasma |
Patients who undergoing Buccal mucosal graft urethroplasty in a standrad protocol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Urethral stricture disease undergoing Buccal Mucosal Graft Urethroplasty |
|
| ExclusionCriteria |
| Details |
a) Patient unfit for surgery/Anaesthesia.
b) Patients with thrombocytopenia
c) Patients with coagulation disorders
d) Patients not giving consent |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
at 3 months and 6 months post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To assess the perioperative complication rate in two groups
|
at 3,6 months |
•To compare recurrence rate of stricture in two groups
|
3,6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [madhav.personal4@gmail.com].
- For how long will this data be available start date provided 01-03-2027 and end date provided 01-03-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
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. |