A clinical study of the effects of the three licensed drugs alfuzosin, tamsulosin and silodosin in patients with benign prostatic hyperplasia, a disease predominantly causing urinary problems in aging men.
- Conditions
- Health Condition 1: null- Benign Prostatic hyperplasia
- Registration Number
- CTRI/2013/07/003805
- 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 more than or equal to 45 years with BPH and associated LUTS;
IPSS more than or equal to 8.
QLS more than or equal to 3.
Qmax less than 15ml but more than 4ml with a voided volume of more than 100ml.
willingness to give written informed consent and comply with the study procedure, and available for regular follow up.
Patients already on 5 alpha reductase inhibitors.
Severe hepatic or renal insufficiency.
Patients concomitantly receiving strong CYP3A4 inhibitors.
UTI.
Urethral stricture.
Neurogenic bladder.
PSA more than or equal to 5ng/ml.
History of urethral or prostatic operation.
Likely to need catheterization within next 3 months.
Hypotension or severe untreated hypertension.
History of esophageal or intestinal obstruction.
Patients receiving drugs that may interfere with the response to study medications within previous 6 months like verapamil, androgens, anti-androgens, diuretics, cholinergics, anti-cholinergics and 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 Change in total INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS) from baseline.Timepoint: 2, 4, 8 and 12 weeks
- Secondary Outcome Measures
Name Time Method Change in peak urinary flow rate (Qmax) and evaluation of subjective symptoms namely IPSS voiding and storage scores and quality of life (QOL) score compared to baseline.Timepoint: 2, 4, 8 and 12 weeks.