| CTRI Number |
CTRI/2025/03/082748 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the treatment outcomes of urethrotomy for urethral stricture using thulium laser versus cold knife in adult males |
|
Scientific Title of Study
|
To compare the outcomes of visual internal urethrotomy for short segment anterior urethral stricture using thulium laser versus cold knife A Prospective Exploratory Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abinash Paul |
| Designation |
Junior Resident |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Department of Urology, Hospital block,AIIMS RISHIKESH,Virbhadra Road, Rishikesh, Uttarakhand 249 203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9101150310 |
| Fax |
|
| Email |
abhinashpal7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abinash Paul |
| Designation |
Junior Resident |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Department of Urology, Hospital block,AIIMS RISHIKESH,Virbhadra Road, Rishikesh, Uttarakhand 249 203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9101150310 |
| Fax |
|
| Email |
abhinashpal7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arup Kumar Mandal |
| Designation |
Professor |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Dept of Urology, AIIMS Academic block,AIIMS RISHIKESH,Virbhadra Road, Rishikesh, Uttarakhand 249 203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9815195979 |
| Fax |
|
| Email |
drarupkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS RISHIKESH |
| Address |
AIIMS RISHIKESH,Virbhadra Road, Rishikesh, Uttarakhand 249 203 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abinash Paul |
AIIMS RISHIKESH |
Department of Urology, Hospital block,Virbhadra Road, Rishikesh, Uttarakhand 249 203
Dehradun
UTTARANCHAL |
9101150310
abhinashpal7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS RISHIKESH INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: N359||Urethral stricture, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cold knife Visual internal urethrotomy |
the urethrotome will be advanced in the urethra through cystoscopy sheath up to the stricture site. The incision will be made using the cold knife at 12 o clock position. The procedure will be repeated till the healthy mucosa with bleeding points appeared to be opened up. Once the stricture is incised, the diagnostic cystoscope will be passed into the urinary bladder |
| Intervention |
Thulium laser Visual internal urethrotomy |
Thulium laser fibre with setting of Pulsed mode with 10 ms,20 W power and 15 Hz frequency will be introduced through the Laser OIU sheath. Incision will be made with the laser fiber at 12 o clock. Once the stricture is ablated, till all fibrotic tissues ablated the diagnostic cystoscope will be passed into the urinary bladder. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
Short Segment Anterior Urethral stricture upto 1 cm
Newly diagnosed Cases and failure following a single previous Visual internal urethrotomy |
|
| ExclusionCriteria |
| Details |
Long segment urethral stricture greater than 1 cm
Multiple Strictures
Recurrent Urethral stricture after 2 attempts of internal urethrotomy
Obliterative Urethral stricture even guidewire could not be passed
Patient not providing informed consent
Active UTI |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the change in peak flow rate,post void residual and IPSS Score of Thulium laser visual internal urethrotomy with that of cold knife visual internal urethrotomy for short segment upto 1 cm anterior urethral stricture in adult males at 1 and 3 months after intervention |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the recurrence rates at 1 and 3 Months of follow up in either procedures
|
3 months |
| To compare the patient reported outcome measures at 1 and 3 months of follow up in either procedures |
3 months |
| To compare the incidence of Complications in either procedures at 1 and 3 months follow up |
3 months |
| To compare the change in sexual function in either procedures at 1 and 3 months follow up |
3 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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="3"
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
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 [abhinashpal7@gmail.com].
- For how long will this data be available start date provided 01-06-2025 and end date provided 28-02-2030?
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
|
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Brief Summary
|
This study is a non randomised,open label, parallel group,single centre trial comparing the outcomes of Thulium laser visual internal urethrotomy with that of cold knife visual internal urethrotomy for short segment upto 1 cm anterior urethral stricture in adult males at 1 and 3 months after intervention.This will be conducted in department of Urology, AIIMS RISHIKESH.The primary outcome measure will be change in peak flow rate, post void residual and IPSS Score at 1 and 3 months post intervention.The Secondary outcome measure will be Recurrence rates, change in IPSS Score, post op complications rate and change in IIEF Score at 1 and 3 months post intervention.
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