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OpenTrials
Completed

NCT Number: NCT00699049

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

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.

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Key information

Conditions

Urinary Bladder, Overactive Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Cheonan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alpha blocker

Drug

oral

Placebo

Drug

oral

solifenacin

Drug

oral

Other names: Vesicare, YM905

Primary outcomes

  1. Achievement level of patients' individual satisfaction

    Time frame: At weeks 4 and 12

Secondary outcomes

  1. Changes in urgency episodes

    Time frame: At weeks 4 and 12

  2. Changes in OAB symptom scores

    Time frame: At weeks 4 and 12

  3. Changes in QoL score by OAB-q

    Time frame: At weeks 4 and 12

Sponsors and collaborators

Lead sponsor

KYU-SUNG LEE

Other

Collaborators

  • Astellas Pharma Korea, Inc.

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 17, 2008
Registry last updated
Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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