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CTRI Number  CTRI/2021/12/038658 [Registered on: 15/12/2021] Trial Registered Prospectively
Last Modified On: 09/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Benefits of mirabegron as an add-on drug to the previously taking medications in patients suffering from excessive night time urination due to prostate enlargement 
Scientific Title of Study   Comparing outcome of silodosin vs silodosin plus mirabegron for nocturia in patients of BEP/LUTS; a double blinded, randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sathaye Shekhar Ulhas 
Designation  Senior resident Urology 
Affiliation  Post Graduation Institute of Medical Education and Research, Chandigarh 
Address  Departmental office, Department of urology, PGIMER Chandigarh, 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  7798727397  
Fax    
Email  ssathaye2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  AMOL N PATIL 
Designation  Associate professor 
Affiliation  Post Graduation Institute of Medical Education and Research, Chandigarh 
Address  In charge Drug information centre, Associate professor, Department of pharmacology, PGIMER, Sector 12,Chandigarh,

Chandigarh
CHANDIGARH
160012
India 
Phone  9990245973  
Fax    
Email  seeamol83@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sathaye Shekhar Ulhas 
Designation  Senior resident Urology 
Affiliation  Post Graduation Institute of Medical Education and Research, Chandigarh 
Address  Departmental office, Department of urology, PGIMER Chandigarh, 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  7798727397  
Fax    
Email  ssathaye2@gmail.com  
 
Source of Monetary or Material Support  
Post graduate Institute of Medical Education and Research, Chandigarh 
 
Primary Sponsor  
Name  Sathaye Shekhar Ulhas 
Address  Senior resident, Deparmtmental office, Department of Urology, PGIMER, Chandigarh 
Type of Sponsor  Other [Other] 
 
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 
Sathaye Shekhar Ulhas  PGIMER Chandigarh  OPD room number 3081, New OPD block ,PGIMER Chandigarh
Chandigarh
CHANDIGARH 
7798727397

ssathaye2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Silodosin  Silodosin- alpha blocker, dosing of 8mg once a day for 2 months to be taken orally 
Intervention  Silodosin and mirabegron  Silodosin- alpha blocker, dosing of 8 mg once a day for 2 months to be taken orally Mirabegron- Beta 3 agonist, dosing of 50 mg once a day for 2 months to be taken orally 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Male 
Details  1.Patients presenting to urology OPD with complaints of nocturia with documented BEP at PGIMER, Chandigarh.
2.Patients willing to participate in the study.
3.Age greater than 40 years
 
 
ExclusionCriteria 
Details  1.Prostate cancer
2.Any contraindication to use mirabegron
3.Recurrent UTI
4.Patients with H/O AUR or PUC placement or patients who are on PUC.
5.Bladder stones.
6.Stricture urethra.
7.Psychogenic polydipsia
8.Prostate surgery in the past.
9.Spinal cord trauma, spinal disease affecting bladder function.
10.Patient not willing to participate in study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparing outcome of Silodosin vs Silodosin plus Mirabegron for nocturia in patients of BEP/LUTS.
 
Baseline, at 1 month, at 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess difference in improvement of overall IPSS score between the two arms.
2. To compare change in sleep quality using ICIQ-NQoL score
3. To compare the adverse events in the two groups.
 
Baseline, at 1 month, at 2 months 
 
Target Sample Size   Total Sample Size="152"
Sample Size from India="152" 
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)   17/12/2021 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Benign Enlargement of prostate (BEP) is a common condition affecting most elderly men, and patients with BEP present with various lower urinary tract symptoms (LUTS). LUTS are commonly divided into three types: Storage symptoms (urinary daytime frequency, nocturia, urgency, incontinence), voiding symptoms (urinary hesitancy, slow stream, straining, splitting or spraying, intermittent stream, terminal dribbling) and post micturition symptoms (feeling of incomplete emptying, post micturition dribbling). Nocturia, defined as waking because of the desire to void during intended sleep, is a storage symptom. Treating bladder outlet obstruction (BOO) is thought to improve nocturia by lowering postvoid residual (PVR) volume, increasing functional bladder capacity, and reducing global urinary frequency. Alpha blockers are medications which act by reducing the BOO. Studies have shown that uro-selective alpha blockers like tamsulosin and silodosin have a significant effect in decreasing nocturia by the above mechanisms. Mirabegron, a selective beta-3 agonist approved for the treatment of OAB symptoms by the US Food and Drug Administration in 2012, acts on the detrusor muscle and relaxes it. Studies have shown that mirabegron helps in reducing nocturia. There have been various studies showing the effectiveness of alpha blockers on treating nocturia. Studies have also shown that mirabegron helps in reducing nocturia. However, there are no randomized studies comparing alpha blocker monotherapy with alpha blocker and beta 3 agonist combination therapy in management of nocturia. This study aims to compare these two groups in the treatment of nocturia. The study is a prospective RCT study, to be done in the Department of Urology and Department of Pharmacology at PGIMER, Chandigarh. The patients will be called back after 4 weeks. The IPSS and the ICIQ-NQoL questionnaires will be repeated at this time along with a 3 day FVC, uroflometry and a USG KUB with PVRU. The patients will then be given medications for 4 more weeks and will be followed up at the end of 8 weeks with IPSS, ICIC-NQoL, FVC, Uroflometry and USG KUB with PVRU. The data collected will be then analyzed.

 
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