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CTRI Number  CTRI/2025/01/079828 [Registered on: 31/01/2025] Trial Registered Prospectively
Last Modified On: 29/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Which Medication Works Best for Stent-Related Urinary Symptoms? A Comparative Study 
Scientific Title of Study   Comparative efficacy of tamsulosin vs. solifenacin vs. mirabegron in relieving double J stent-related lower urinary tract symptoms (LUTS): A randomised control 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  Ankit Shettar  
Designation  Senior Resident  
Affiliation  AIIMS Jodhpur  
Address  #151, Ratan nagar, AIIMS road, Jodhpur
Department of Urology,AIIMS, OPD Room no 550, AIIMS road, Jodhpur.
Jodhpur
RAJASTHAN
342008
India 
Phone  9480445744  
Fax    
Email  ankitshetter@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shiv Charan Navriya 
Designation  Associate Professor  
Affiliation  AIIMS Jodhpur  
Address  AIIMS Faculty complex, AIIMS Campus Jodhpur
Department of Urology, AIIMS, OPD Room no 550, AIIMS Road, Jodhpur- 342005
Jodhpur
RAJASTHAN
342005
India 
Phone  9958365510  
Fax    
Email  buddingurologist@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shiv Charan Navriya 
Designation  Associate Professor  
Affiliation  AIIMS Jodhpur  
Address  AIIMS Faculty complex, AIIMS Campus Jodhpur
Department of Urology, AIIMS, OPD Room no 550, AIIMS Road, Jodhpur- 342005.
Jodhpur
RAJASTHAN
342005
India 
Phone  9958365510  
Fax    
Email  buddingurologist@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  AIIMS JODHPUR 
Address  All india institute of medical sciences, AIIMS Road, Basni industrial area, Jodhpur- 342005. 
Type of Sponsor  Research institution and hospital 
 
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 Ankit Shettar  AIIMS JODHPUR  Department of Urology, OPD roomm No 550, AIIMS Road, Basni industrial area, Jodhpur- 342005.
Jodhpur
RAJASTHAN 
9480445744

ankitshetter@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS JODHPUR INSTITUTIONAL ETHIS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N22||Calculus of urinary tract in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Tab. Mirabegron 25mg OD orally for 4 weeks  efficacy 3 different drugs 
Comparator Agent  Tab. Solifenacin 5mg OD orally for 4 weeks  Efficacy of 3 different drugs 
Comparator Agent  Tab. Tamsulosin 0.4mg OD orally for 4 weeks  Efficacy of 3 different drugs 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Presence of a Double J stent in the urinary tract. • Complaints of lower urinary tract complaints. 
 
ExclusionCriteria 
Details  Previous treatment with any of the study medications. Contraindications to the use of any study medication. Presence of other significant urinary tract pathology. Pregnancy or breastfeeding. Any condition that may interfere with the study assessments or participation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Using the Ureteric stent symptom score (USSQ), we will be investigating the efficacy of tamsulosin, solifenacin, and mirabegron in lowering DJ stent related symptoms in this study.  Baseline, 2 weeks and 4 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
To study the impact of LUTS on quality of life (QOL) in patients with DJ stent. To identify the factors that increase the incidence of LUTS in patients with DJ stent.
 
Baseline, 2 weeks & 4 weeks 
 
Target Sample Size   Total Sample Size="123"
Sample Size from India="123" 
Final Enrollment numbers achieved (Total)= "123"
Final Enrollment numbers achieved (India)="123" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/02/2025 
Date of Study Completion (India) 01/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Double-J (DJ) stents, commonly used to relieve ureteral obstructions, often cause lower urinary tract symptoms (LUTS) such as pain, haematuria, and urinary tract infections, significantly impacting patients’ quality of life. These symptoms primarily result from bladder irritation and ureteral spasms caused by the stent’s positioning and movement. While alpha-blockers like tamsulosin and anticholinergics like solifenacin have shown effectiveness in managing these symptoms, the role of beta-3 agonists, such as mirabegron, is less explored despite it’s success in treating overactive bladder (OAB). With limited research comparing the efficacy of these medications for DJ stent-related LUTS, there is a critical need for further studies to address this gap and identify optimal treatment strategies to enhance patient care.

Hypothesis: Compared to other medications, mirabegron shows comparable results on LUTS and performs better on overactive bladder symptoms due to DJ stents. Tamsulosin shows similar results to that of Mirabegron, and there is no additional benefit of using the combination.

 
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