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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)

NCT01747577 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-11-07

No results posted yet for this study

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.

Conditions

  • Overactive Bladder
  • Benign Prostate Hyperplasia
  • Transurethral Resection of Prostate
  • Photoselective Vaporization Prostatectomy

Interventions

DRUG

Solifenacin Succinate

Oral

DRUG

Placebo

Oral

Sponsors & Collaborators

  • Astellas Pharma Korea, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-04
Primary Completion
2013-10-24
Completion
2013-10-24

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01747577 on ClinicalTrials.gov