Health Condition 1: null- Benign prostate hypertrophy (BPH) with accompanying overactive bladder (OAB). Health Condition 2: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
Intervention1: Tab Tamsulosin Hydrochloride
Cap Darifenacin Hydrobromide: Tab Tamsulosin Hydrochloride 0.4mg given orally once a day at bed time after meals with sips of water for period of eight week
Sponsors
University College of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male patients aged 40-80 years diagnosed as symptomatic BPH with accompanying OAB 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 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, medical disorders etc. 2.Patients of BPH presenting with acute urinary retention (AUR- risk of AUR as ascertained by MFR 150 ml/s and/or progressively rising PVR) , renal failure, untreated urinary tract infection and vesical stones. 3.Patients with diabetes mellitus, polyuria, orthostatic hypotension, allergy / hypersensitivity / contraindications to one or more alpha-adrenoceptor antagonists / antimuscarinics/anticholinergics. Patients receiving any drugs known to interfere with pharmacodynamics of tamsulosin/darifenacin. 4.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 number of urinary frequencies in 24 hours and mean change in number of incontinence episodes per day that resulted in change in clothing.Timepoint: Mean change from baseline to week 8 in number of urinary frequencies in 24 hours and mean change in number of incontinence episodes per day that resulted in change in clothing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline to week 8 in number of voiding episodes per night, mean change in PVR and total IPSS.Timepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Gaurav Garg
University College of Medical Sciences University of Delhi GTBH
Outcome results
None listed