Clinical trial NCT00884104: A Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: Solifenacin
Tamsulosin
OAB
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Korea, Inc.
First posted: 2009-04-20
Enrollment: 307
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with "add-on" solifenacin treatment
timeFrame: Weeks of 12, 24 and 52 of combination therapy
Secondary outcomes:
measure: Change from baseline in micturition efficacy parameters
timeFrame: Weeks of 12, 24 and 52 of combination therapy
Other outcomes:
Locations:
city: Cheon-ju
country: Korea, Republic of
city: Choongju
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Kangneung
country: Korea, Republic of
city: Kwang-ju
country: Korea, Republic of
city: Pusan
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
Study officials:
affiliation: University School of Medicine, Kangnan-ku, Seoul, Korea
name: Kyu-Sung Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.