A study to find out the medication which offers maximum health benefits with minimum spending by the patient among the three commonly used medications in the treatment of benign prostatic hyperplasia, a disease in aging men which results in bothersome urinary problems.
- Conditions
- Health Condition 1: null- Patients of benign prostatic hyperplasia between the age of 45 to 90 years who are otherwise maintaining a good general health.
- Registration Number
- CTRI/2013/10/004112
- Lead Sponsor
- Dr Manjunatha R
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 90
•Male subjects >= 45 years with BPH and associated lower urinary tract symptoms (LUTS).
•International prostate symptom score (IPSS) >= 8
•Quality of life score (QLS) >= 3
•Maximum flow rate (Qmax) < 15ml/s but > 4ml/s with a voided volume of >100 ml
•Willingness to give written informed consent and to comply with the study procedure, and available for regular follow up.
•Patients already on 5 α reductase inhibitors
•Severe hepatic or renal insufficiency
•Patients concomitantly receiving strong CYP3A4 inhibitors
•Urinary tract infections
•Urethral stricture
•Neurogenic bladder
•PSA >= 5ng/ml
•History of urethral or prostatic operation
•Likely to need catheterization within next 3 months
•Hypotension or severe untreated hypertension
•History of oesophageal or intestinal obstruction
•Patients receiving the drugs that may interfere with the response to study medications, within previous 6 months like verapamil, androgens, anti androgens, diuretics, cholinergics, anticholinergics, phytotherapy
•History of alcohol or drug abuse
•Currently suffering from serious disease or malignancy
•Significant psychiatric problems
•Patients at increased risk of QTc prolongation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method