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CTRI Number  CTRI/2024/10/074802 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 24/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Broad Assessment of Scope of Integrating Two Types of Questionnaires for evaluating perioperative and post operative outcomes and experiences of patients who undergo either an open surgery or Endoscopic procedure for urethral stricture  
Scientific Title of Study   Comprehensive Prospective Assessment Of Patient Reported Outcome Measures PROMs And Patient Reported Experience Measures PREMs For Non traumatic Bulbar Urethral Stricture Patients Undergoing Urethroplasty and Visual Internal Urethrotomy In Indian Population A Tertiary Health Care Centre Study.  
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 Sanjith Kamath N  
Designation  Senior resident -Mch Urology 
Affiliation  Kasturba Medical College Manipal  
Address  Room Number -14 Department of Urology and Renal Transplant Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  08904617604  
Fax    
Email  sanjithkamath34.sk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Kumar Chawla 
Designation  Professor and Unit Chief -Mch Urology 
Affiliation  Kasturba Medical College Manipal  
Address  Room Number -14 Department of Urology and Renal Transplant Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  9008002440  
Fax    
Email  arun.chawla@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sanjith Kamath N  
Designation  Senior resident -Mch Urology 
Affiliation  Kasturba Medical College Manipal  
Address  Room Number -14 Department of Urology and Renal Transplant Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  08904617604  
Fax    
Email  sanjithkamath34.sk@gmail.com  
 
Source of Monetary or Material Support  
OPD Number -14 Department of Urology and Renal transplant Kasturba Medical College Manipal ,Affilated to Manipal Academy of Higher Education -576104-India Telephone number-0820-2922242 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal Department of Urology and Renal transplant  
Address  Kasturba Medical College Manipal,Affilated to Manipal Academy of Higher Education 576104 India -Telephone Number-0820-2922242  
Type of Sponsor  Private medical college 
 
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 Sanjith Kamath N   Kasturba Hospital   Department Of Urology and Renal Transplant Kasturba Medical College Manipal -576104
Udupi
KARNATAKA 		 8904617604

sanjithkamath34.sk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N358||Other urethral stricture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Male 
Details  All non-traumatic bulbar urethral stricture male patients aged more than 18 years and above
with no previous history of urethroplasty admitted in Department of Urology in Kasturba Medical
college Manipal willing to undergo Urethroplasty and Visual Internal Urethrotomy . 
 
ExclusionCriteria 
Details  1) Patients who undergo staged urethroplasty .
2)Recurrent non traumatic bulbar urethral stricture urethral patients following urethroplasty in the
past.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation of modified PROM(Jackson et al; ) and modified PREM questionnaire (Jenkinson et al;) with clinical outcomes using quality of health via visual analogue quality of life health scale following urethroplasty and VIU in non traumatic bulbar urethral stricture patients   Baseline data -preoperatively
Postoperatively on Day 1, 3monthS, 6months ,12 months respectively.
 
 
Secondary Outcome  
Outcome  TimePoints 
Stricture free outcome for Urethroplasty & Visual internal urethrotomy will be assessed by
uroflowmetry & cystourethroscopy in patients reporting worst health outcomes . 		 Baseline data -preoperatively
Postoperatively on Day 1, 3monthS, 6months ,12 months respectively. 
 
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   N/A 
Date of First Enrollment (India)   07/10/2024 
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="2"
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 - NO
Brief Summary   Non traumatic Bulbar Urethral stricture disease can have a significant negative impact on patient quality of life. Treatment is tailored for each individual patient and depends on the aetiology, stricture location, length, and degree of associated spongiofibrosis ,choice of surgical technique based on the location and length of the stricture, as well as on surgeon preference. 
This study highlights the importance of PROMs and PREMs in urethral reconstructive surgery, emphasizing that success should not be defined only by stricture-free survival, but also there exists clear impetus to align and implement international PROM and PREM programs collectively together  to enable global health system performance measurement and to collectively drive patient-centred, value based healthcare thus improving the health outcomes following Urethroplasty and Visual Internal Urethrotomy
The study will be only conducted only after obtaining permission from the institutional ethical committee. Confidentiality of data of patients will be maintained. The investigations done will be a part of routine procedure under standard protocol for the management of urethral stricture. Patients with urethral stricture disease will be initially assessed using the inclusion and exclusion criteria mentioned in the above protocol and non traumatic bulbar urethral stricture patients will be selected and recruited in the study after taking written informed consent. Patients will undergo surgical intervention(Urethroplasty/VIU) based on surgeon’choice. Assessment of health outcomes using Assessment of health outcome using Modified PROM(Jackson et al;) and modified PREM questionnaire(Jenkinson et al;) for patients undergoing Urethroplasty and Visual internal Urethrotomy will be done preoperatively as well as postoperatively at POD-1,3,6 and 12 months followup period will be done, accordingly loss to followup and drop up rate will be assessed. Statistical Analysis will be calculated using STATA/SPSS Software version 21. Correlation of modified PROM (Jackson et al; ) modified PREM questionnaire(Jenkinson et al;) with patient -based health outcomes and quality of life via visual analogue quality of lifehealth scale will be done . Stricture free outcome rates will be assessed on followups. Recurrence rate will be assessed accordingly in patients reporting worst health outcomes(quality of life) by means of cystourethroscopy and uroflowmetry.
Type of study:Prospective -Longitudinal study .As study is being conducted for a period of one year ,the desired sample size may not be able to achieve(85 subjects in each group), hence the study is made time bound.
Potential benefits : There will be an benefit in improving overall quality of life in patients undergoing urethroplasty and Visual internal urethrotomy for non-traumatic bulbar urethral strictures by integrating the PREM and PROM questionnaire in the Indian health system thus improvising the existing standard existing system for a better outcome. Risks: Anxiety related issues while filling the questionnaire. No additional risks apart from the standard risks associated with the procedure (Urethroplasty or Visual internal urethrotomy.
Tools used :Modified PROM (Jackson et al; ) ,Modified PREM questionnaires (Jenkinson et al;) and visual analogue quality of life health scale for non-traumatic bulbar urethral stricture willing to undergo Urethroplasty and Visual Internal Urethrotomy. Radiological investigations: Ascending urethrogram, Micturating Cystourethrogram. Functional urological investigations: Uroflowmetry. Other diagnostic investigations :Cystourethroscopy .
 
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