â??Tamsulosin and darifenacinâ?? versus â??tamsulosinâ?? for â??benign prostate hypertrophy with accompanying overactive bladderâ??

Not Applicable

Completed

Conditions: Health Condition 1: null- Benign prostate hypertrophy (BPH) with accompanying overactive bladder (OAB).Health Condition 2: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

Registration Number: CTRI/2014/08/004811

Lead Sponsor: niversity College of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

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

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 < 5 ml/s, voided volume < 50 mls, USG proven PVR >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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures