| 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
|
|
|
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
|
|
|
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. |