NCT00884104

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 20, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

1.8 years

First QC Date

March 25, 2009

Last Update Submit

January 6, 2016

Conditions

Overactive Bladder

Keywords

SolifenacinTamsulosinOAB

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with "add-on" solifenacin treatment

    Weeks of 12, 24 and 52 of combination therapy

Secondary Outcomes (1)

  • Change from baseline in micturition efficacy parameters

    Weeks of 12, 24 and 52 of combination therapy

Study Arms (1)

1.tamsulosin + solifenacin

EXPERIMENTAL
Drug: Solifenacin

Interventions

SolifenacinDRUG

Oral

Also known as: Vesicare
1.tamsulosin + solifenacin

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Cheonju, South Korea

Location

Unknown Facility

Choongju, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Kangneung, South Korea

Location

Unknown Facility

Kwangju, South Korea

Location

Unknown Facility

Pusan, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Suwon, South Korea

Location

Related Publications (1)

  • Lee HN, Lee KS, Kim JC, Chung BH, Kim CS, Lee JG, Kim DK, Park CH, Park JK, Hong SJ. Rate and associated factors of solifenacin add-on after tamsulosin monotherapy in men with voiding and storage lower urinary tract symptoms. Int J Clin Pract. 2015 Apr;69(4):444-53. doi: 10.1111/ijcp.12581. Epub 2014 Nov 1.

    PMID: 25363606DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Kyu-Sung Lee, MD

    University School of Medicine, Kangnan-ku, Seoul, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 25, 2009

First Posted

April 20, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

KR(9)