Health Condition 1: N33- Bladder disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Fixed Dose Combination of Silodosin 8 mg and Mirabegron 25/50 mg Tablets: Fixed Dose Combination of Silodosin 8 mg and Mirabegron 25/50 mg Tablets as add on therapy.
Daily one tablet f
Sponsors
M/s. Windlas Biotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male subjects 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 or equal to8 per day and urinary urgency episodes greater than or equal to per day).2. Subjects willing to give voluntary their written informed consent to participate in the study before being screened for the study.3. Able to adhere to study visit schedule and other protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Subject having a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction 2. Subject having Urinary retention requiring catheterization 3. Subject having symptomatic, untreated urinary tract infection not resolved prior to starting of investigational products 4. Subject taking Botulinum toxin injection for Urgency Urinary Incontinence UUI in the last year 5. Current therapy with peripheral or sacral neuromodulation 6. Neurologic conditions that may affect urinary function like stroke,multiple sclerosis, spinal cord injury, Parkinsons disease 7. Subjects 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 8. Subjects with severe renal insufficiency or ongoing or planned dialysis. 9. Subjects with documented severe hepatic impairment with or without cirrhosis according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin greater than 3 times ULN accompanied by AST greater than ULN assessed at screening and or Child Pugh Class C 10. Serum AST and or ALT greater than 3 times ULN assessed at screening 11. Men who are unwilling to use contraception while receiving investigational product 12. Known or suspected hypersensitivity to investigational products or any other component of the formulation 13. Failure to control systemic fungal, bacterial or viral infection 14. Known human immunodeficiency virus HIV or hepatitis B or C classes of active viral infection 15. Subjects with suspected signs and symptoms of COVID19 or confirmed novel coronavirus infection COVID19 or with a recent history of travel or contact with any COVID19 positive subject or isolation or quarantine in the last 14 days 16. Have a history of neurological or psychiatric disorders, including epilepsy or dementia 17. According to the investigators judgment, there are concomitant diseases with a serious safety hazard or affect the subjects participation in the study in subjects 18. Using other experimental drugs or participating in other clinical trials in the prior one month 19. Concomitant life-threatening disease with a life expectancy less than 12 months 20. Any factor or condition likely to affect protocol compliance of the subject as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Change in Total Overactive Bladder Symptom Score (OABSS) from baseline to week 12 Secondary endpoint: Number of Micturitions Per 24 Hours at week 4, week 8 and week 12 and compare to baseline (Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI)). Number of micturition Urgency Episodes per 24 Hours at week 4 and week 8 and week 12 Number of UUI Episodes Per 24 Hours at week 4 and week 8 and week 12 Number of Nighttime Micturitions Per 24 Hours at week 4 and week 8 and week 12Timepoint: Primary endpoint: Change in Total Overactive Bladder Symptom Score (OABSS) from baseline to week 12 Secondary endpoint: Number of Micturitions Per 24 Hours at week 4, week 8 and week 12 and compare to baseline (Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI)). Number of micturition Urgency Episodes per 24 Hours at week 4 and week 8 and week 12 Number of UUI Episodes Per 24 Hours at week 4 and week 8 and week 12 Number of Nighttime Micturitions Per 24 Hours at week 4 and week 8 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Assessments ? Adverse events (AEs) during the study Proportion of subjects with adverse events and serious adverse events during treatment period. Adverse events including medically significant laboratory changesincidence, severity, causality and outcome will be collected from the signing of informed consent form until discontinuation of study treatment due to disease progression, intolerability, withdrawal of consent, death or treatment completionTimepoint: Baseline, Week 4, Week 8 and week 12 | — |
Countries
India
Contacts
Public ContactMr Prashant Dabral
Abiogenesis clinpharm private Limited
Outcome results
None listed