| CTRI Number |
CTRI/2024/12/078046 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Mirabegron and Solifenacin versus Mirabegron Over Active Bladder |
|
Scientific Title of Study
|
Efficacy and safety of Mirabegron
Monotherapy versus combination of
Mirabegron and Solifenacin in patients with
Over active bladder- A Randomized
Prospective open label observational study
at a tertiary care teaching hospital in
South India.
|
| 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 Karri Parvathi |
| Designation |
Postgraduate |
| Affiliation |
Sri Venkateswara Institute Of Medical Sciences- SPMCW |
| Address |
Department of Pharmacology,Sri venkateswara institute of medical sciences(SVIMS),alipiri road,tirupati.
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493051069 |
| Fax |
|
| Email |
dr.k.parvathireddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karri Parvathi |
| Designation |
Postgraduate |
| Affiliation |
Sri Venkateswara Institute Of Medical Sciences- SPMCW |
| Address |
Department of Pharmacology,Sri venkateswara institute of medical sciences(SVIMS),alipiri road,tirupati.
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493051069 |
| Fax |
|
| Email |
dr.k.parvathireddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrCPallavi |
| Designation |
Associate Professor |
| Affiliation |
Sri Venkateswara Institute Of Medical Sciences- SPMCW |
| Address |
Department of Pharmacology,Sri venkateswara institute of medical sciences(SVIMS),alipiri road,tirupati.
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9959956433 |
| Fax |
|
| Email |
pallavispmcw@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.K.Parvathi, Junior resident, Department of pharmacology,Sri Venkateswara institute of medical sciences (SVIMS),Tirupati-517501. |
|
|
Primary Sponsor
|
| Name |
Dr Karri Parvathi |
| Address |
Dr.K.Parvathi, Junior resident, Department of Pharmacology,Sri Venkateswara institute of medical sciences (SVIMS),Tirupati-517501. |
| 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 K PARVATHI |
Sri Venkateswara Institute Of Medical Sciences |
Room NO.45,Department of Urology ,OP Block.
Chittoor
ANDHRA PRADESH |
9493051069
dr.k.parvathireddy@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES |
Approved |
| Institutional Ethics Committee, SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N319||Neuromuscular dysfunction of bladder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
comparing with combination of Mirabegron and Solifenacin
|
Mirabegron monotherapy vs Mirabegron and Solifenacin.
Comparing the effects of both groups by using USS score, OAB score, PVR volume.
The following efficacy assessments will be done at baseline and during follow-up visits at week 4, 8 and 12.
safety and tolerability assessments will be done at baseline, week 4, 8 and 12.
The following efficacy assessments will be done at baseline and during follow-up visits at week 4, 8 and 12. |
| Intervention |
Mirabegron monotherapy |
Mirabegron monotherapy vs Mirabegron and Solifenacin.
Comparing the effects of both groups by using USS score, OAB score, PVR volume
The following efficacy assessments will be done at baseline and during follow-up visits at week 4, 8 and 12.
safety and tolerability assessments will be done at baseline, week 4, 8 and 12.
The following efficacy assessments will be done at baseline and during follow-up visits at week 4, 8 and 12. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Men and women aged 18- 60 years experiencing symptoms of OAB for ≥ 3 months.
2.They should have frequency of micturition on an average ≥ 8 times per 24 h.
3.They should have at least three episodes of urgency, with or without incontinence.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant / lactating Female
2.Clinically significant bladder outflow obstruction
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
o compare the efficacy of mirabegron 50mg monotherapy versus mirabegron 50mg plus
solifenacin 5mg combination therapy in patients of over active bladder |
at 4 weeks and 12 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the safety and tolerability of mirabegron 50mg monotherapy with combination of mirabegron 50mg plus solifenacin 5mg. |
at 4 weeks and 12 weeks of treatment |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
31/12/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
After completion of study would like to submit for publication. |
|
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 (Others) - NIL
- 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
Response (Others) - NIL
- Who will be able to view these files?
Response (Others) - NIL
- For what types of analyses will this data be available?
Response (Others) - NIL
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 05-07-2027 and end date provided 14-10-2027?
Response (Others) - NIL
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Title : Efficacy and safety of Mirabegron monotherapy versus combination of Mirabegron and Solifenacin in patients with over active bladder- A randomized prospective open label observational study at a tertiary care hospital in South India AIM: To compare the efficacy and safety of mirabegron monotherapy versus combination therapy of mirabegron and solifenacin in patients of over active bladder. PRIMARY OBJECTIVE To compare the efficacy of mirabegron 50mg monotherapy versus mirabegron 50mg plus solifenacin 5mg combination therapy in patients of over active bladder. SECONDARY OBJECTIVE To compare the safety and tolerability of mirabegron 50mg monotherapy with combination of mirabegron 50mg plus solifenacin 5mg. METHODOLOGY STUDY DESIGN A randomized prospective comparative open label observational parallel group study. STUDY SITE The study will be conducted in the department of Urology, Sri Venkateswara Institute of Medical Sciences (SVIMS)-Tirupati, Andhra Pradesh. STUDY SUBJECTS All over active bladder patients who comes to urology OPD and who will be started on mirabegron 50mg monotherapy or combination of mirabegron 50mg plus solifenacin 5mg. INCLUSION CRITERIA - Men and women aged 18 - 60 years experiencing symptoms of OAB for ≥ 3 months.
- They should have frequency of micturition on an average ≥ 8 times per 24 h.
- They should have at least three episodes of urgency, with or without incontinence
EXCLUSION CRITERIA - Pregnant / lactating Female
- Clinically significant bladder outflow obstruction
§ Significant post-void residual (PVR) volume (> 1/3rd of full bladder volume- FBV) § Male with prostate volume > 20cc in ultrasound § Patients with predominant stress incontinence § Diabetes Mellitus with uncontrolled blood sugars (HbA1C ≥ 9% ) § Active urinary tract infection § Interstitial cystitis, bladder stones § Previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs § Severe renal impairment or End Stage Renal disease. STUDY DURATION: One year following the Thesis Protocol Approval Committee (TPAC) and Institutional Ethics Committee (IEC) approval. SAMPLE SIZE Total estimated sample size – 100 (50/group including 5% dropouts) EFFICACY PARAMETERS Ø Urgency Severity Scale (USS)21 Ø OAB Symptom Score (OABSS)22 Ø Post void residual (PVR) volume will be evaluated at baseline and end of study.
|