Comparison of mirabegron versus tamsulosin patients of benign prostate enlargement with overactive bladdder symptoms.

Not Applicable

Conditions: Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptomsHealth Condition 2: N328- Other specified disorders of bladder

Registration Number: CTRI/2018/12/016541

Lead Sponsor: niversity College of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Male patients aged 40-80 years diagnosed as symptomatic BPH with coexisting overactive bladder symptoms (OABS) with an IPSS >8 and not desiring surgery.

2.Symptomatic patients of BPH (determined by LUTS and supplemented by IPSS/focused urological exam/Investigations) associated with any one or more of the following overactive bladder symptoms like; micturition frequency of >8 per 24 hrs, nocturia episodes of > 2 per 24 hrs, urgency episodes of >1 per 24 hrs with or without urge incontinence.

3.Patients should be willing and able to complete a 3 day voiding diary and questionnaires.

Exclusion Criteria

1.Patient not willing for consent for inclusion in the above study and those who cannot comply with the study protocol due to concomitant CVA, CRF, Vesical stones, untreated UTI Diabetic neuropathy ,uncontrolled hypertension (BP >180/100), neurological ds etc.

2.Patients of BPH with absolute indications for surgery

3.Patients with contraindication, hypersensitivity and allergic reaction to components of mirabegron and or tamsulosin hydrochloride.

4.Patients on drugs known to interfere with pharmacodynamics of tamsulosin/mirabegron.

5.Patients with prior history of prostatic/urethral surgery, acute or chronic prostatitis, known prostate cancer, suspected neurogenic bladder, urethral stricture and priapism.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change from baseline to week 8 in the overall overactive bladder symptom score(OABSS)Timepoint: Eight weeks

Secondary Outcome Measures

Name	Time	Method
1. Secondary outcome end points will be mean change in the number of voiding episodes per night, mean change in PVR and changes in IPSS respectively from the baseline to week 8. <br/ ><br>2. Other secondary outcomes will include treatment emergent clinical & laboratory adverse events/side effects (TEAEs) with its end points at all visits.Timepoint: All visits up to eight weeks