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CTRI Number  CTRI/2025/09/095435 [Registered on: 26/09/2025] Trial Registered Prospectively
Last Modified On: 26/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “Study on the Effectiveness of Tamsulosin + Solifenacin vs Mirabegron + Silodosin in Reducing Symptoms Caused by Ureteral Stents” 
Scientific Title of Study   Clinical efficacy of Tamsulosin and Solifenacin combination vs Mirabegron and Silodosin Combination in double J ureteral stent related symptoms:A Randomized contorl 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 Abhishek chhabra 
Designation  Senior resident 
Affiliation  AIIMS BATHINDA 
Address  Department of urology ,AIIMS BATHINDA

Bathinda
PUNJAB
151001
India 
Phone  9423073780  
Fax    
Email  drabhi.chhabra796@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kawaljit singh kaura 
Designation  Associate Professor and Head 
Affiliation  AIIMS BATHINDA 
Address  Department of urology,AIIMS BATHINDA

Bathinda
PUNJAB
151001
India 
Phone  7054414482  
Fax    
Email  kskaura@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhishek chhabra 
Designation  Senior resident 
Affiliation  AIIMS BATHINDA 
Address  Department of urology , AIIMS BATHINDA

Bathinda
PUNJAB
151001
India 
Phone  9423073780  
Fax    
Email  drabhi.chhabra796@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bathinda,PUNJAB,INDIA PINCODE-151001 
 
Primary Sponsor  
Name  AIIMS Bathinda 
Address  Mandi Dabwali Road, Bathinda, Punjab 151001 
Type of Sponsor  Government 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 
Abhishek Chhabra  AIIMS BATHINDA  DEPARTMENT OF UROLOGY, AIIMS BATHINDA
Bathinda
PUNJAB 
09423073780

drabhi.chhabra796@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE” ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BATHINDA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Drug combination for 6 weeks  amsulosin (0.4 mg) and Solifencain (10 mg) per oral combination once daily in group A and Silodosin 8 mg and Mirbegron 50 mg per oral combination once daily in group B for DJ stent related symtpoms for 6 weeks 
Comparator Agent  Silodosin 8 mg and Mirbegron 50 mg per oral for 6 weeks  Silodosin 8 mg and Mirbegron 50 mg for 6 weeks combination per oral once daily in group B for DJ stent related symtpoms 
Comparator Agent  Tamsulosin (0.4 mg) and Solifencain (10 mg) per oral Drug combination in Group A for 6 weeks  Tamsulosin (0.4 mg) and Solifencain (10 mg) per oral combination once daily in group A for 6 weeksfor DJ stent related symtpoms  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.All patients who will be undergoing Double J ureteral stent placement during ureterscopic removal of stone

2.All patients who will be undergoing Double J ureteral stent placement during Percutaneous nephrolithotomy

3.Age 18 years to 60 years of all genders consenting for study
 
 
ExclusionCriteria 
Details  1.Patients who are already prescribed any of drugs which are being studied in this research either in monotherapy or in combination (tamsulosin, mirabegron, solifenacin or silodosin)
2.Patients who had residual stone fragments after surgical intervention
3.Patients underwent bilateral double J stent placement.
4.Pregnant patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary Endpoint:
Mean USSQ score at six weeks

 
six weeks

 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Endpoints:
a) Mean USSQ score at one week
b) Mean USSQ score at 3 weeks
 
ONE WEEK
THREE WEEKS 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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/ Phase 3 
Date of First Enrollment (India)   10/10/2025 
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
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [abhi.chhabra796@gmail.com].

  6. For how long will this data be available start date provided 10-01-2026 and end date provided 10-01-2031?
    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  

Ureteral stents are now very commonly used in various urological disorders Ureteral stents are frequently used to relieve obstruction of urinary tract to secure ureteral anastomoses and to provide effective drainage of upper urinary tract after various urological interventions. The term stent-related symptoms SRS refers to a broad range of symptoms in the early postoperative phase include transient fever hematuria frequency urgency and pain in the flank and or suprapubic area

The symptoms associated with a DJ stent can present clinically like an overactive bladder and are mediated by cholinergic and alpha adrenergic receptors The three main pharmacological types that have been studied over the past few decades and found out to be beneficial in reducing stent associated symptoms are beta 3 agonists alpha blockers and anticholinergics

Tamsulosin and silodosinin are specific alpha1a inhibitors that inhibit the contraction of the lower ureter bladder neck and bladder trigone muscles hence reducing pain and discomfort associated with the lower urinary tract

 The only selective beta 3 adrenergic agonist available for treating overactive bladder is mirabegron. It works by reducing patients’ irritation in the bladder when they have a ureteral stent in situ

Ureteral Stent Symptom Questionnaire USSQ is a questionnaire which is self administered and assesses aspects of stent related symptoms Patients will be randomized into two groups 1 to 1 by a computer generated randomization

Group A patients will be given tamsulosin 04 mg and solifencain 10 mg combination once daily Group B patients will be given Silodosin 8 mg and Mirabegron 50 mg combination once daily All patients are to be followed up for 6 weeks from double J stent placement Comparisons of clinical demographic and intraoperative findings will be done and patients will be followed up in terms of symptoms using USSQ score at 1 week post procedure 3 and 6 weeks post procedure

 

 
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