Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms Health Condition 2: N328- Other specified disorders of bladder
Conditions
Interventions
Intervention1: Cap Tamsulosin Hydrochloride and Tab Mirabegron: One CAP TAMSULOSIN HCL 0.4mgs to be given once daily at bed time after meals with sips of water for eight weeks. Along with One Tab Mira
Sponsors
University College of Medical Sciences
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline to week 8 in the overall overactive bladder symptom score(OABSS)Timepoint: Eight weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 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 | — |
Countries
India
Contacts
Public ContactDr Dibya Priyadarsini Behera
University College of Medical Sciences University of Delhi GTBH
Outcome results
None listed