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CTRI Number  CTRI/2025/09/095485 [Registered on: 30/09/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to test a modified surgical technique for women with recurrent urethral narrowing 
Scientific Title of Study   Efficacy of Modified Dorsal Vaginal Graft Urethroplasty in Recurrent Female Urethral Strictures: A Single-Center Feasibility 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  Shitangsu Kakoti 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Guwahati 
Address  Department of Urology, AIIMS Guwahati, Changsari

Kamrup
ASSAM
781101
India 
Phone  07002199137  
Fax    
Email  drshitangsu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shitangsu Kakoti 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Guwahati 
Address  Department of Urology, AIIMS Guwahati, Changsari


ASSAM
781101
India 
Phone  07002199137  
Fax    
Email  drshitangsu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shitangsu Kakoti 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Guwahati 
Address  Department of Urology, AIIMS Guwahati, Changsari


ASSAM
781101
India 
Phone  07002199137  
Fax    
Email  drshitangsu@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Guwahati, Changsari, Assam-781101 
 
Primary Sponsor  
Name  Dr Shitangsu Kakoti 
Address  AIIMS Guwahati, Changsari, Assam-781101 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shitangsu Kakoti  All India Institute of Medical Sciences, Guwahati  Department of Urology, AIIMS Guwahati, Changsari
Kamrup
ASSAM 
07002199137

drshitangsu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, AIIMS Guwahati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Modified Dorsal Vaginal Graft Urethroplasty   Identical Dorsal Vaginal Graft procedure augmented with a thin labial fat-pad pedicled flap, deliberately thinned (target 5 to 7 mm) and tunnelled to overlay the graft as a vascular cover without compressing the lumen. Dose: Not applicable (single surgical procedure) Frequency: Once only Route of administration: Surgical Total duration: Single operative session; follow-up as per protocol 
Comparator Agent  Standard dorsal vaginal graft urethroplasty  Standard dorsal vaginal graft urethroplasty as per institutional SOP (graft harvest, dorsal onlay, quilting to corporal bed, urethral catheterisation). Dose: Not applicable (single surgical procedure) Frequency: Once only Route of administration: Surgical Total duration: Single operative session; follow-up as per protocol 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  Symptomatic recurrent urethral stricture confirmed objectively (calibration less than 14 Fr, uroflow pattern with low Qmax, urethroscopy or VCUG).
At least one prior failed treatment.
Able to provide informed consent and comply with follow-up.
 
 
ExclusionCriteria 
Details  Severe vaginal atrophy or scarring precluding graft harvest.
Prior labial surgery compromising labial vascularity.
Active urinary tract infection at randomization
Prior pelvic irradiation, pregnancy, neurogenic bladder, contraindication to anesthesia or surgery, or inability to give consent.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Consent rate (percentage of eligible patients consenting).
Recruitment rate (patients/month).
Protocol adherence (percentage receiving allocated procedure).
Retention rate at 6 months (percentage completing primary follow-up).
Safety signal: incidence of intervention-related major complications (Clavien–Dindo Grade more than or equal to III). 
Baseline, 2 weeks, 6 weeks, and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Primary efficacy metric (exploratory) Change in maximum urinary flow rate (Qmax, mL/s) from baseline to 6 months. Qmax equal to best of two technically adequate uroflowmetry readings.
Urethral patency at 6 months (composite symptom relief plus ability to calibrate more than 16 Fr plus no re-intervention).
Recurrence rate (need for dilation or urethrotomy or re-urethroplasty).
Post-void residual (PVR, mL).
Quality of life UDI-6.
Sexual function PISQ-12.
Donor-site outcomes pain VAS, hematoma, wound dehiscence, cosmetic concern.
Operative time, estimated blood loss, & length of stay.
Adverse events (AEs/SAEs) & their Clavien grading 
Baseline, 2 weeks, 6 weeks, & 6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 4 
Date of First Enrollment (India)   15/10/2025 
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="0"
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drshitangsu@gmail.com].

  6. For how long will this data be available start date provided 01-03-2027 and end date provided 01-03-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This is a single-center, parallel-group, feasibility randomized controlled trial that will evaluate a modified technique of dorsal vaginal graft (DVG) urethroplasty in adult women with recurrent symptomatic urethral stricture. DVG urethroplasty is an established reconstructive technique, but variable sizes of graft thickness and suboptimal vascular support may limit graft survival. The labial fat pad flap, pedicled on the posterior labial artery and thinned to minimize bulk, may enhance vascularization and improve graft take; however, it has not been tested in a randomized setting. Using the postoperative Qmax variability as reference, we will enrol 30 patients (15 per arm) to primarily assess feasibility metrics—consent and recruitment rates, protocol adherence, retention at 6 months, and early safety (Clavien–Dindo grade  III or more complications)—and secondarily estimate the between-group difference and variance in Qmax at 6 months, along with exploratory outcomes of urethral patency, recurrence, quality of life (UDI-6), donor-site morbidity, sexual function (PISQ-12), operative time, and hospital stay. Eligible participants are adult women (more than 18 years) with objectively confirmed recurrent urethral stricture after prior failed intervention; exclusions include significant vaginal atrophy/scarring, prior labial surgery compromising vascularity, active UTI, prior pelvic radiation, pregnancy, and neurogenic bladder. Randomization will be 1:1, stratified by surgical approach, with concealed allocation; surgeons will be unblinded, but outcome assessors for uroflowmetry and statisticians will be blinded where feasible. The control group will undergo standard DVG urethroplasty per institutional SOP; the intervention group will receive identical surgery plus thin labial fat-pad augmentation. Perioperative protocols (antibiotics, catheter duration, analgesia, wound care) will be as per the standard of care. Follow-up visits at 2 weeks, 6 weeks, and 6 months will include uroflowmetry (Qmax), post-void residual, symptom assessment, questionnaires, donor-site exam, and complication reporting. Feasibility outcomes will be reported as proportions with 95% confidence intervals; exploratory efficacy will be analyzed using ANCOVA for Qmax at 6 months, adjusting for baseline values, with results expressed as adjusted mean difference and 95% CI. Binary outcomes will be summarized with proportions and 95% CI, without formal hypothesis testing for small effects; missing data will be described, with observed data used for primary reporting.

 
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