| 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
|
|
|
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
|
|
|
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
- 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 - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- 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.
- 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 [abhi.chhabra796@gmail.com].
- 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.
- 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
|