Health Condition 1: null- benign prostatic hyperplasia
Conditions
Interventions
Intervention1: capsule silodosin 8 mg: 1 capsule daily after meal at night for 12 weeks
Control Intervention1: capsule TAMSULOSIN 0.4 mg: 1 capsule daily after meal at night for 12 weeks
Sponsors
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: • 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 ( • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| effectiveness of silodosin in benign prostatic hyperplasia assessed by symptom relief as assessed by IPS scoring. The total score was taken as the sum of the seven individual symptom scores. a quality of life (QoL) assessment was done on a 7-point scale . quality of sexual life assessed by a 6-item questionnaire that formed part of the broader symptom scoring. Timepoint: Screening visit, baseline visit, follow up visit at 4th, 8th and 12th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects who become completely or relatively symptom free (IPS score less than 8) after 12 weeks of treatment. Change in prostate size, in terms of weight / volume, as assessed by USG. Changes in peak urine flow rate and allied uroflowmetry parameters. Safety profile of silodosinTimepoint: Screening visit, baseline visit, follow up visit at 4th, 8th and 12th week | — |
Countries
India
Contacts
Public ContactSATABDI PANDE
Institute of Postgraduate Medical Education and Research
Outcome results
None listed