Study comparing the effectiveness of new drug Tadalafil vs Tamsulosin for medical treatment of Benign Prostatic Hyperplasia

Not Applicable

Completed

• Conditions: Health Condition 1: null- Benign Prostatic HyperplasiaHealth Condition 2: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

• Registration Number: CTRI/2018/08/015344
• Lead Sponsor: Dr Sai Vijay Boya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-10-09
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1.Patients with Lower Urinary Tract Symptoms for at least or more than 6 months at screening

2.Patients with a total International Prostate Symptom Score (IPSS) greater than or equal to 13.

3.Patients who agree not to use any other approved or experimental pharmacologic BPH, overactive bladder (OAB), or erectile dysfunction (ED) treatments anytime during the study.

4.Patients who have not taken other BPH therapy (including herbal preparations), OAB therapy, ED therapy for at least 4 weeks prior to study drug is dispensed. Subjects reporting use of BPH, overactive bladder, or ED therapy underwent a 4-week treatment-free washout period.

Exclusion Criteria

1.Prostate-specific antigen (PSA) >10.0 ng/ml (if �4.0 to �10.0 ng/ml, malignancy has to be ruled out)

2.Post void residual (PVR) volume �300 ml at screening.

3.Subjects with the use of finasteride or dutasteride within the recent 3 or 6 months respectively.

4.Recent lower urinary tract instrumentation (within 30 days)

5.Subjects with history of urinary retention or lower urinary tract stones within the last 6 months.

6.Subjects with history of urethral and/or proven bladder neck obstruction secondary to reasons other than BPH.

7.Patients with the diagnosis or features suggestive of neurogenic bladder.

8.Creatinine clearance < 30 ml/min.

9.Severe hepatic impairment.

10.Cardiovascular conditions with the risk of hypotension and the patients who require or are on current nitrate therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (IPSS)Timepoint: At the commencement, at every two weeks during study and at the end of study period

Secondary Outcome Measures

Name	Time	Method
1.Post Void residue (PVR) at the completion of study <br/ ><br>2.IPSS Voiding sub score <br/ ><br>3.IPSS Storage sub score <br/ ><br>4.Benign Prostatic Hyperplasia Index <br/ ><br>5.Patient Global Impression of Improvement (PGI-I) index questionnaire <br/ ><br>Timepoint: PVR and PGI index will be assessed at the end of study and others will be assessed <br/ ><br>at the commencement, at every two weeks during study and at the end of study period