Clinical Trials Directory

Trials / Completed

CompletedNCT01747577

Post Marketing Study to Evaluate the Efficacy and Safety of Solifenacin in Patients With OAB (Overactive Bladder) After TURP (Trans-urethral Resection of Prostate) or PVP (Photoselective Vaporization of Prostate)

A Randomized, Double-blind, Placebo-controlled, Parallel-group, and Phase IV Study of Efficacy and Safety of Solifenacin Succinate in Patients With Overactive Bladder After TURP or PVP

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
68 (actual)
Sponsor
Astellas Pharma Korea, Inc. · Industry
Sex
Male
Age
50 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to demonstrate superiority of the solifenacin succinate (treatment) over the placebo (control) based on the change from the baseline in the mean number of urgency episodes per 24 hours after 2 weeks.

Detailed description

The BPH (benign prostate hyperplasia) patients who have OAB (overactive bladder) after TURP (trans-urethral resection of prostate) or PVP (photoselective vaporization of prostate) will participate in this study. The subjects will be randomized 1:1 to the solifenacin succinate group or to the placebo treatment group. The subjects shall take investigational product each night before sleeping from for four weeks and complete voiding diary. At Week-2 and Week-4 of the treatment, the subjects will be asked to complete the following activities: physical exam, vital signs test, IPSS, OABSS, post-void residual (PVR) test, and uroflowmetry, and will be asked to answer the BSW, (Benefit, Satisfaction and Willingness to Continue Questions) questionnaire.

Conditions

Interventions

TypeNameDescription
DRUGSolifenacin SuccinateOral
DRUGPlaceboOral

Timeline

Start date
2012-12-04
Primary completion
2013-10-24
Completion
2013-10-24
First posted
2012-12-11
Last updated
2024-11-07

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01747577. Inclusion in this directory is not an endorsement.