| 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
|
|
|
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
|
|
|
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
- 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 - Study Protocol Response - Statistical Analysis Plan
- 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drshitangsu@gmail.com].
- 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.
- 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. |