Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
Intervention1: FDC of Tamsulosin Hydrochloride 0.4 mg + Mirabegron 25 mg Prolonged Release Tablets.: One tablet once a day orally, swallowed with water around same time every day for 8 weeks.
Interve
Sponsors
Ravenbhel Healthcare Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Total Overactive Bladder Symptom Score (OABSS) from baseline to week 8. Change in International Prostate Symptom Score (IPSS) from baseline to week 8Timepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Ravindra Mote
Mediclin Clinical Research
Outcome results
None listed