Tamsulosin and Solifenacin taken together compared with Tamsulosin alone for Benign Prostatic Enlargement patients who have features of overactive bladder

Phase 4

• Conditions: Health Condition 1: null- Benign prostatic hyperplasia with overactive bladder symptoms

• Registration Number: CTRI/2017/07/008984
• Lead Sponsor: Cipla Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Lower Urinary Tract Symptoms for more than 3 months, that are

Attributable to Benign Prostatic Hyperplasia (BPH), as confirmed with

International Prostate Symptom Score of greater than 8, and who have

Maximum urine flow rate of less than 12 ml/second, with voided volume more than 120 ml and

Post-void residue measured by Ultrasound (USG) of less than 120 ml,

Overactive bladder symptoms of more than 8 voids in 24 hours, more than 2 voids at night, and more than 1 episode of urgency in 24 hours

Exclusion Criteria

History of

Urinary retention in preceding 12 months, or

Treatment of BPH with alpha-receptor antagonists, plant extracts, and or 5-alpha-reductase inhibitors, or

Other causes of LUTS e.g., urethral stricture, or

Neurogenic bladder

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes from baseline to end-of-treatment in patient reported symptoms of <br/ ><br>Total IPSS scores <br/ ><br>Total Urgency and Frequency Scores <br/ ><br>Timepoint: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Changes from baseline to end-of-treatment in patient reported symptoms of <br/ ><br>Storage subscore of IPSS <br/ ><br>Voiding subscore of IPSS <br/ ><br>Voiding episodes in 24 hours <br/ ><br>Nocturnal voids in 24 hours <br/ ><br>Urgency episodes in 24 hours <br/ ><br>Timepoint: After 12 weeks