Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
Intervention1: Tadalafil: Tadalafil 5mg one tablet/capsule orally, once daily 30 minutes before bed.
Control Intervention1: Tamsulosin: Tamsulosin hydrochloride 0.4mg one capsule/tablet orally, once d
Sponsors
All India Institute of Medical Sciences Raipur Chhattisgarh
Eligibility
Inclusion criteria
Inclusion criteria: (1) Men between ages 45-65 years, diagnosed with BPH-LUTS without any h/o medical or surgical intervention for BPH and International Prostate Symptom Score (IPSS) >=8 i.e. moderate to severe (having difficulty in managing LUTS). (2) No absolute indication for surgical intervention. (3) Prostate Specific Antigen (PSA) (4) Quality of Life Score (QoL) >= 3. (5) Maximum Urinary Flow Rate (Qmax) â?? between 4 to 15 mL/s. (6) Patients willing to participate in the study giving â??Written Informed Consentâ??.
Exclusion criteria
Exclusion criteria: (1) Patients who need surgical intervention for their prostatic problem. (2) Prior exposure to 5-Alpha reductase inhibitor and/or Phosphodiesterase type 5 inhibitor within one month. (3) H/o surgical procedure for their prostatic problem (4) H/o pelvic surgery, radiotherapy, lower urinary tract malignancy, recent urinary retention, neurological condition affecting bladder function (Spinal Cord Injury). (5) Person receiving nitrates, α-blockers or any other vasodilator, cancer chemotherapy, antiandrogens, potent cytochrome P450 3A4 inhibitors. (6) Alcoholics. (7) Patients having ocular disorder. (8) Patients with h/o episode of priapism. (9) Patients planned or planning for cataract surgery in next 4-6 months. (10) Patient with h/o Hypersensitivity to study drugs. (11) Known case of hepatic or renal disorders. (12) H/o Myocardial Infarction within the last 90 days. (13) Unstable angina or angina occurring during sexual intercourse. (14) New York Heart Association Class 2 or greater heart failure in the last 6 months. (15) Uncontrolled arrhythmias, hypotension ( (16) Stroke within the last 6 months. (17) Urinary tract stone. (18) Active urinary tract infection. (19) Hematuria. (20) Prostate Cancer. (21) Urethral Stricture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in International Prostate Symptom Score (IPSS) at the end of 12-week follow-up.Timepoint: First Visit (Baseline, 0 week) Second Visit (4th week) Third Visit (12th week) | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition to above outcome measures, we will evaluate erectile dysfunction (ED) by International Index of Erectile Function (IIEF-5) questionnaire irrespective of presence or absence of ED.Timepoint: First Visit (Baseline, 0 week) Second Visit (4th week) Third Visit (12th week);Proportion of patients discontinued due to treatment emergent adverse drug reactions.Timepoint: First Visit (Baseline, 0 week) Second Visit (4th week) Third Visit (12th week);Proportion of patients with improvement in maximum urine flow rate (Qmax).Timepoint: First Visit (Baseline, 0 week) Second Visit (4th week) Third Visit (12th week);Proportion of patients with improvement in Quality of Life Score (QoL).Timepoint: First Visit (Baseline, 0 week) Second Visit (4th week) Third Visit (12th week) | — |
Countries
India
Contacts
Public ContactDr Vikas Katiyara
All India Institute of Medical Sciences, Raipur (Chhattisgarh)
Outcome results
None listed