| 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
|
|
|
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
|
|
|
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
|
|
|
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. |