Efficacy and safety of tadalafil in men with lower urinary tract symptoms associated with enlarged prostate.

Phase 4

• Conditions: Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

• Registration Number: CTRI/2018/10/015963
• Lead Sponsor: All India Institute of Medical Sciences Raipur Chhattisgarh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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) < 4ng/dL.

(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

(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 ( <90/50 mm Hg), or uncontrolled hypertension.

(16) Stroke within the last 6 months.

(17) Urinary tract stone.

(18) Active urinary tract infection.

(19) Hematuria.

(20) Prostate Cancer.

(21) Urethral Stricture

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in International Prostate Symptom Score (IPSS) at the end of 12-week follow-up.Timepoint: First Visit (Baseline, 0 week) <br/ ><br>Second Visit (4th week) <br/ ><br>Third Visit (12th week)

Secondary Outcome Measures

Name	Time	Method
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)