A Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks

Overactive Bladder Clinical Trial

Official title:

A Prospective, Open-label, Observational, Multi-center Study for the Identification of Predictive Factors for the Solifenacin Treatment in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks and Evaluation of Efficacy and Persistency of Add on Solifenacin in Men With Residual Overactive Bladder Symptoms After Previous Monotherapy With Tamsulosin.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884104
• Other study ID #: SMK-3
• Status: Completed
• Phase: Phase 4
• First received: March 25, 2009
• Last updated: January 6, 2016
• Start date: March 2009
• Est. completion date: December 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 evaluate the rate of "add-on" solifenacin treatment and its persistency in men with over active bladder symptoms after tamsulosin monotherapy for 4 weeks.

Description:

This is a multi-center study to evaluate the efficacy, safety, and persistency of solifenacin treatment in male patients with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence who are receiving tamsulosin monotherapy for LUTS at a stable dose for 4 weeks in real life practice. Also proportion of patients and predictive factors with persistent OAB symptoms after tamsulosin monotherapy will be investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• IPSS = 12

• Symptoms of OAB as verified by the V8 (=8)

• Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:

• Mean urinary frequency =8 times/24 hours

• Mean number of micturition-related urgency episodes =3 episode/24 hours (with a Urinary Sensation Scale rating of =3 marked for the corresponding micturition in the bladder diary)

Exclusion Criteria:

• Treatment within the 14 days preceding treatment with any alpha blocker drugs

• A known history of bladder outlet obstruction due to: bladder neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• 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	Percentage of patients with "add-on" solifenacin treatment		Weeks of 12, 24 and 52 of combination therapy	No
Secondary	Change from baseline in micturition efficacy parameters		Weeks of 12, 24 and 52 of combination therapy	No