CTRI/2025/09/094209 [Registered on: 03/09/2025] Trial Registered Prospectively
Last Modified On:
09/12/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A Study to Compare the Effectiveness and Safety of Two Combination Medicines Tamsulosin Hydrochloride plus Mirabegron PR vs Silodosin plus Mirabegron ER in Men with Enlarged Prostate and Overactive Bladder Symptoms
Scientific Title of Study
A Multicentric Randomized Double Blind Active Controlled Prospective Parallel Group Comparative Phase III Clinical Study to Evaluate the Efficacy Safety and Tolerability of FDC of Tamsulosin Hydrochloride plus Mirabegron Prolonged Release Tablets versus FDC of Silodosin plus Mirabegron ER Film Coated Bilayered Tablets in Adult Patients Diagnosed with Benign Prostatic Hyperplasia Complicated by Overactive Bladder with Symptoms of Urge Urinary Incontinence Urgency and Frequency
Trial Acronym
NILL
Secondary IDs if Any
Secondary ID
Identifier
Protocol ID : MCR/CT/0224/09 V No: 02 Date : 06 Sep 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Tapan Kumar Mandal
Designation
Principal Investigator
Affiliation
Nil Ratan Sircar Medical College and Hospital
Address
138, Acharya Jagdish Chandra Bose Rd, Sealdah, Raja Bazar, Kolkata, West Bengal 700014
Kolkata WEST BENGAL 700014 India
Phone
9830367795
Fax
Email
study.tkmandal@gmail.com
Details of Contact Person Scientific Query
Name
Dr Ravindra Mote
Designation
Director
Affiliation
Mediclin Clinical Research
Address
107, Prime Trade Center,
BLDG No- 1/A, Vasai East 401208,
Maharashtra, INDIA.
Palghar MAHARASHTRA 401208 India
Phone
8888884024
Fax
Email
ravindra.mote@mediclincr.com
Details of Contact Person Public Query
Name
Dr Ravindra Mote
Designation
Director
Affiliation
Mediclin Clinical Research
Address
107, Prime Trade Center,
BLDG No- 1/A, Vasai East 401208,
Maharashtra, INDIA.
Palghar MAHARASHTRA 401208 India
Phone
8888884024
Fax
Email
ravindra.mote@mediclincr.com
Source of Monetary or Material Support
Ravenbhel Healthcare Pvt. Ltd
16-17,EPIP,SIDCO,Kartholi,Bari Brahamana,Samba-181133,Jammu and Kashmir,India
Primary Sponsor
Name
Ravenbhel Healthcare Pvt. Ltd.
Address
16-17,EPIP,SIDCO,Kartholi,Bari Brahamana,Samba-181133,Jammu and Kashmir,India
Umang Vasant Utsav CHS, next to Thakur Stadium, Thakur Village, Kandivali East, Mumbai, Maharashtra 400101 Mumbai (Suburban) MAHARASHTRA
9820271476
aniruddhagokhale217@gmail.com
Dr Vinay Kumar
GSVM Medical College
Opd No 30,Ground Floor,GSVM Medical College,Department of Surgery, Swaroop Nagar, Kanpur-208002, UP, India. Kanpur Nagar UTTAR PRADESH
9660640989
vinaysinghkgmc99@gmail.com
Dr Sameer Trivedi
Institute of Medical Sciences Banaras Hindu University
Department of Urology, Institute of Medical Sciences
Banaras Hindu University, Varanasi,U.P-221005,India Varanasi UTTAR PRADESH
9839861656
drsameertrivedi@gmail.com
Dr Anil Samaria
Jawahar Lal Nehru Medical College
Department of General medicine, Ground Flr,Unit 5,Sr Professor room no.1, Jawahar Lal nehru medical college, Kalabaug, ajmer Ajmer RAJASTHAN
8118877284
Clinical.jln@gmail.com
Dr Sunil Palve
Lifeline Multispeciality Hospital
OPD NO. 1,Ground Flr,145/1, Mumbai – Bangalore Highway, Near Hotel Sayaji, Wakad, Pune-411057 Pune MAHARASHTRA
9511845960
sunilpalve01@gmail.com
Dr Prasad HL
Mysore Medical College & Research Institute
2nd Flr,Room No 2,Department of Urology,Princess Krishnajammanni Super Speciality Hospital,Mysore medical College lst cross Rd, Brindavan Extension l st stage, opposite to ESI Hospital, Mysuru Karnataka-570015 Mysore KARNATAKA
9633254370
drprasadhl@gmail.com
Dr Tapan Kumar Mandal
Nil Ratan Sircar Medical College and Hospital
Department of Urology,Ground Flr,138, Acharya Jagdish Chandra Bose Road, Kolkata 700014, West Bengal, India Kolkata WEST BENGAL
9830367795
study.tkmandal@gmail.com
Dr Nipun AC
Rajalakshmi Hospital & Research Center
Department of Urology,Ground Flr, Room No 2,21/1, Lakshmipura Main Road, Vidyaranyapura Post, Lakshmipura, Bengaluru, Karnataka 560097 Bangalore KARNATAKA
One tablet once a day orally, swallowed with water around same time every day for 8 weeks.
Inclusion Criteria
Age From
45.00 Year(s)
Age To
65.00 Year(s)
Gender
Male
Details
1.Male patients aged 45 to 65 years (both inclusive) with confirmed diagnosis of benign prostatic hyperplasia complicated by overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency (including micturitions greater than equal to 8 per day and urinary urgency episodes greater than equal to 1 per day).
2.Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
3.Patients willing to comply with the protocol requirements.
ExclusionCriteria
Details
1. Patients with known or suspected hypersensitivity to investigational products or any other component of the formulation.
2. Patients having a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction.
3. Patients having urinary retention requiring catheterization.
4. Patients having symptomatic, untreated urinary tract infection not resolved prior to starting of investigational products.
5. Patients taking Botulinum toxin injection for urgency urinary incontinence (UUI) in the last year.
6. Patients current therapy with peripheral or sacral neuromodulation.
7. Patients with neurologic conditions that may affect urinary function like stroke, multiple sclerosis, spinal cord injury, Parkinsons disease.
8. Patient with clinically significant bladder outflow obstruction other than BPH (except large median lobe) due to calculi, tumor or stricture.
9. Patients with glycosylated hemoglobin (HbA1c) greater than equal to 07 percent at screening.
10. Patients with significant cardiac disorder (e.g., cardiac valve disease requiring a specific treatment, pericardial constriction, life-threatening arrhythmia, uncontrolled hypertension, acute myocardial infarction, permanent atrial fibrillation).
11. Patients with severe renal insufficiency or ongoing/planned dialysis.
12. Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 2X the UNL) at screening.
13. Patients who are unwilling to use contraception while receiving investigational product.
14. Patients with failure to control systemic fungal, bacterial or viral infection.
15. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
16. Patients with a history of neurological or psychiatric disorders, including epilepsy or dementia.
17. Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
18. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
19. Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
20. Patients with suspected inability or unwillingness to comply with the study procedures.
21. Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Change in Total Overactive Bladder Symptom Score (OABSS) from baseline to week 8.
Change in International Prostate Symptom Score (IPSS) from baseline to week 8
8 weeks
Secondary Outcome
Outcome
TimePoints
Number of Micturition Per 24 Hours a week 2, week 4 and week 8 and compare to baseline (Micturition include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI)).
Number of micturition Urgency Episodes per 24 Hours at week 2, week 4 and week 8.
Number of UUI Episodes Per 24 Hours at week 2, week 4 and week 8.
Number of Night-time Micturition Per 24 Hours at week 2, week 4 and week 8.
8 weeks
Target Sample Size
Total Sample Size="228" Sample Size from India="228" 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 3
Date of First Enrollment (India)
15/09/2025
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)
Open to Recruitment
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
Benign prostatic hyperplasia (BPH) is the most common benign disease in men with various lower urinary tract symptoms (LUTS) and is the fourth most common disease among men aged 50 years and older; the prevalence of BPH in men aged 70 years and older is more than 80%.17 BPH results in LUTS clinically, and symptoms can be classified as storage, voiding, and postmicturition, and often affect patients’ quality of life (QoL). Patients with BPH may have one predominant type of symptom rather than other symptoms, and symptoms often appear in different forms as the disease progresses. According to the EPIC study, the prevalence of storage (men, 51.3%; women, 59.2%), voiding (men, 25.7%; women, 19.5%), and postmicturition LUTS (men, 16.9%; women, 14.2%) are generally similar between men and women, and prevalence increases with age. According to Silva et al.,18 it is difficult to aim for newer effective and well-tolerated selective treatments for BPH/LUTS due to an incomplete understanding of the mechanism of the cause and progression of the disease. Overactive bladder (OAB) is classified as a symptom syndrome presenting with urinary urgency with or without urgency incontinence, and usually with frequency and nocturia. In addition, it worsens patients’ QoL.4 The European Association of Urology offers practical evidence-based guidelines on the assessment and treatment of men aged 40 years and older who present with LUTS.19 They also recommend that medical history, validated symptom score questionnaires, voiding diary, physical examination, including digital rectal examination, urinalysis, prostate-specific antigen (PSA), and frequency volume chart are helpful as an initial assessment of BPH. The International Prostatic Symptom Score (IPSS) is used to assess urinary symptom severity and QoL.20 It is also used to document subjective responses to treatment. Measurement of urinary flow rates and residual urine is helpful in diagnostic evaluation and treatment response. Many male patients with LUTS do not need medical management or surgical intervention, but patients with moderate-to-severe LUTS require medical or surgical treatment. Alpha-1 adrenoceptor blocker (A1B) is the most commonly used pharmacological agent to treat LUTS in men with BPH.21 However, even after treatment with A1B, storage or OAB symptoms may persist. The 2015 European Urologic Association guideline recommends antimuscarinics or beta-3-adrenoceptor agonists (B3A) in men with BPH to treat moderate-to-severe LUTS with predominant bladder storage symptoms, and when both monotherapies are insufficient to relieve symptoms, a combination therapy of A1B and antimuscarinic agents is recommended.