| CTRI Number |
CTRI/2024/02/063069 [Registered on: 23/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of medicines used for overactive bladder (fesoterodine vs mirabegron vs solifenacin) |
|
Scientific Title of Study
|
A comparative study of fesoterodine vs mirabegron vs solifenacin in cases of overactive bladder. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vyoma Desai |
| Designation |
Resident in M.ch Urology |
| Affiliation |
DR PSIMS and RF, VIJAYAWADA |
| Address |
Department of urology
Dr. PSIMS and RF hospital
Vijayawada
Andhra pradesh
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9601925776 |
| Fax |
|
| Email |
drvysd25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. P. Bala Murali Krishna |
| Designation |
Associate professor of urology |
| Affiliation |
DR PSIMS and RF, VIJAYAWADA |
| Address |
Department of urology
DR. PSIMS and RF
Vijayawada
Andhra pradesh
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
6351827300 |
| Fax |
|
| Email |
sainathjsd@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. P. Bala Murali Krishna |
| Designation |
Associate professor of urology |
| Affiliation |
DR PSIMS and RF, VIJAYAWADA |
| Address |
Department of urology
DR PSIMS and RF
VIJAYAWADA
ANDHRA PRADESH
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9601925776 |
| Fax |
|
| Email |
drvysd25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. PSIMS and RF,
chinnavutapalli, gannavaram, vijayawada, Andhra Pradesh - 521286 |
|
|
Primary Sponsor
|
| Name |
VYOMA DESAI |
| Address |
Department of urology
Dr. PSIMS and RF Vijayawada |
| Type of Sponsor |
Other [Self] |
|
|
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 VYOMA DESAI |
Dr. PSIMS and RF hospital |
department of urology, first floor, Dr. PSIMS and RF hospital, chinna avutapalli, gamnavaram, vijayawada
Krishna
ANDHRA PRADESH |
9601925776
drvysd25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - DR. PSIMS and RF |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N328||Other specified disorders of bladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FESOTERODINE |
8 mg twice a day per oral for 15 days |
| Intervention |
MIRABEGRON |
50 mg twice a day per oral for 15 days |
| Intervention |
SOLIFENACIN |
10 mg twice a day per oral for 15 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All cases of overactive bladder undergoing treatment at Dr. PSIMS and RF hospital |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study
Patients lost to follow up
Patients less than 18 years of age
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in OABSS score |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant side effects |
15 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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="1"
Months="6"
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
|
Overactive bladder is associated with significant impact on quality of life because of the troublesome symptoms. Pharmacotherapy is the main stay of treatment. This study compares the three main drugs used in treatment of overactive bladder- fesoterodine, mirabegron and solifenacin |