Efficacy and safety of â??tamsulosin and darifenacinâ?? versus â??tamsulosin monotherapyâ?? for â??BPH with accompanying overactive bladderâ??- a randomized clinical study.

niversity College of Medical Sciences0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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.

发起方

niversity College of Medical Sciences