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

• ClinicalTrials.gov Identifier: NCT00699049
• Recruitment Status: Completed
• First Posted: June 17, 2008
• Last Update Posted: January 7, 2016
• Sponsor: KYU-SUNG LEE
• Collaborator: Astellas Pharma Korea, Inc.
• Information provided by (Responsible Party): KYU-SUNG LEE, Samsung Medical Center

Tracking Information

• First Submitted Date: June 16, 2008
• First Posted Date: June 17, 2008
• Last Update Posted Date: January 7, 2016
• Study Start Date: June 2008
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 16, 2008): Achievement level of patients' individual satisfaction [ Time Frame: At weeks 4 and 12 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 16, 2008)

• Changes in urgency episodes [ Time Frame: At weeks 4 and 12 ]
• Changes in OAB symptom scores [ Time Frame: At weeks 4 and 12 ]
• Changes in QoL score by OAB-q [ Time Frame: At weeks 4 and 12 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder
• 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
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Urinary Bladder, Overactive

Intervention

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

  • Vesicare
  • YM905

Study Arms

• Placebo Comparator: Alpha blocker and placebo
  Interventions:

  • Drug: Alpha blocker
  • Drug: placebo
• Experimental: Alpha blocker and solifenacin
  Interventions:

  • Drug: Alpha blocker
  • Drug: solifenacin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 8, 2010): 94
• Original Estimated Enrollment (submitted: June 16, 2008): 103
• Actual Study Completion Date: March 2010
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT00699049
• Other Study ID Numbers: SMK-1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: KYU-SUNG LEE, Samsung Medical Center
• Study Sponsor: KYU-SUNG LEE
• Collaborators: Astellas Pharma Korea, Inc.

Investigators

• Study Chair: Central Contact; Astellas Pharma Inc

• PRS Account: Samsung Medical Center
• Verification Date: January 2016