Head to head trial between silodosin and tamsulosin in benign prostatic hyperplasia.
- Conditions
- Health Condition 1: null- benign prostatic hyperplasia
- Registration Number
- CTRI/2014/01/004366
- Lead Sponsor
- INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Male subjects above 50 years age
History of prostate symptoms for at least 6 months
International prostate symptom score (IPSS) at presentation > 7
Diagnosis of BPH confirmed by a baseline ultrasonographic scan.
Willing to provide written informed consent
Willing to comply with the trial protocol.
•Subject judged to have severe bladder neck obstruction, in imminent need of surgery.
•History of carcinoma prostate.
• History of urethral stricture.
•History of acute retention of urine.
• History of active urinary tract disease or history of cystoscopy or biopsy from the urinary
•tract within past 2 weeks.
• History of failed surgery for BPH (including failed transurethral resection of prostate) for
•any reason.
• History of treatment with any medication known to influence prostate function within
•past 1 month (including estrogenic and androgenic agents).
• History of persistently low blood pressure ( < 90 mmHg systolic and / or < 60 mmHg
•diastolic) or history of syncopal attacks.
• Serious disease of vital organs like heart, liver, kidneys or bone marrow.
• History of alcohol or substance abuse.
• History of treatment with any herbal remedies within past 1 month.
•Participation in any other clinical trial within past 3 months.
• Any other condition, which in the opinion of the investigators, is not conducive to inclusion of the subject in the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method