A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder

Urinary Bladder, Overactive Clinical Trial

Official title:

A Randomized, Double Blind, Placebo-Controlled, Parallel Group Comparison of the Efficacy and Safety of Any Alpha Blocker Monotherapy and Any Alpha Blocker Plus Solifenacin in Men With Residual Overactive Bladder Symptoms of Urinary Frequency and Urgency With/Without Urgency Incontinence After Previous Monotherapy With Any Alpha Blocker

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699049
• Other study ID #: SMK-1
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2008
• Last updated: January 6, 2016
• Start date: June 2008
• Est. completion date: March 2010

Study information

• Verified date: January 2016
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore additional benefit of solifenacin after 12-week treatment, compared with alpha blocker monotherapy in men with residual OAB symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Persistent symptoms of OAB as verified by the 3 day voiding diary, defined by:

• symptoms of urinary urgency (defined as a level of >=3 in a 5 point urgency scale) at least two episode per 24 hours and

• symptoms of urinary frequency ( >8 micturitions per 24 hours)

• On a stable dose of tamsulosin for at least 1 month

Exclusion Criteria:

• Previous history of acute urinary retention

• Patients have a baseline post-void residual (PVR) which exceeded 50% of voided urine volume

• Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention

• Symptomatic acute urinary tract infection (UTI) during the screening period

• Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs and drug treatment for overactive bladder

• A 5-alpha reductase inhibitor if started less than 3 months prior to screening

• Patients with previous urethral, prostate or bladder neck surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Drug:
• Alpha blocker
oral
• placebo
oral
• solifenacin
oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
KYU-SUNG LEE	Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement level of patients' individual satisfaction		At weeks 4 and 12	No
Secondary	Changes in urgency episodes		At weeks 4 and 12	No
Secondary	Changes in OAB symptom scores		At weeks 4 and 12	No
Secondary	Changes in QoL score by OAB-q		At weeks 4 and 12	No