| CTRI Number |
CTRI/2025/01/079019 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two Treatments for Female Urethral Stricture: Augmentation Urethroplasty vs. Incision Urethrotomy |
|
Scientific Title of Study
|
Comparison of outcome of augmentation urethroplasty versus incision urethrotomy in females with urethral stricture disease – A 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 |
Dr Bibin Sunny |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Patna |
| Address |
Deparment of Urology
Phulwarisharif, Patna, Bihar-801507, India
Patna
BIHAR
801507
India |
| Phone |
08870503358 |
| Fax |
|
| Email |
bibinsunny2011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bibin Sunny |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Patna |
| Address |
Deparment of Urology
Phulwarisharif, Patna, Bihar-801507, India
BIHAR
801507
India |
| Phone |
08870503358 |
| Fax |
|
| Email |
bibinsunny2011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bibin Sunny |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Patna |
| Address |
Deparment of Urology
Phulwarisharif, Patna, Bihar-801507, India
BIHAR
801507
India |
| Phone |
08870503358 |
| Fax |
|
| Email |
bibinsunny2011@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Patna Phulwarisharif, Patna, Bihar-801507, India |
|
|
Primary Sponsor
|
| Name |
AIIMS PATNA |
| Address |
AIIMS Patna
Phulwarisharif, Patna, Bihar-801507, India
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vipin Chandra |
AIIMS Patna |
Department of Urology
3 rd floor OPD building
Phulwari Sharif
Patna, Bihar
Patna
BIHAR |
8442840839
ccchandra2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Patna |
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 |
Augmentation urethroplasty |
Buccal muscosal graft will be harvested from the patinet and urethroplasty done with the same over a period of 1 year and 6 months |
| Comparator Agent |
Incision urethrotomy |
Urethrotomy done with OTIS urethrotome upto 30 Fr, study over a period of 1 year and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Those who belong to above mentioned age group and having urethral stricture proven either by clinical or radiological evidence, who are ready to give consent |
|
| ExclusionCriteria |
| Details |
Age not belonging to inclusion criteria, those who are not giving consent for surgery, patients with neurogenic bladder, genital prolapse and previous surgeries for urethral stricture will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate and compare the outcomes of augmentation urethroplasty and incision urethrotomy in resolving urethral stricture in females. This includes assessing improvement in urinary symptoms (AUA symptom score betterment), restoration of normal urinary flow (Qmax more than 15 ml/sec) and reduction in PVR (to less than 100ml) |
At 3 months and 6 months postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare short term recurrence (6 months) of urethral stricture after augmentation urethroplasty and incision urethrotomy |
6 months |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 2 |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
My thesis is to compare outcomes of augmentation urethroplasty with incision urethrotomy in females with urethral stricture. I will be including female patients in the age group of 18 years to 75 years, who were diagnosed with urethral strictutre clinically and radiologically. Patients will be randomely allotted into two groups by block randomization method, one group will undergo augmentation urethroplasty and other will undergo incision urethrotomy. I will be comparing the outcomes of both above mentioned procedures at 3 months and 6 months like symptomatic improvement and recurrence of stricture. |