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Completed

NCT Number: NCT00985387

Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients

The purpose of the study is to assess patient's persistency in maintaining solifenacin treatment for overactive bladder.

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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 Overactive Bladder Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bucheon-si, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Overactive bladder symptoms lasting for more than 3 months
  • The question 3 score of the overactive bladder symptom score(OABSS)≥ 2 and the sum score of OABSS ≥ 3
  • Symptoms of urinary urgency defined as a level of 1 to 2 in a 3-point Urgency Perception Scale (UPS)

Exclusion criteria

  • Any condition that would contraindicate their usage of anticholinergic treatment, including: urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis
  • Symptomatic acute urinary tract infection (UTI)
  • Diagnosed or suspected of interstitial cystitis
  • Treatment with anticholinergic drugs for over 3 months within 12 months prior to the study
  • Pregnant or nursing women
  • Treatment within the 14 days before the study or expected to initiate treatment during the study with any anticholinergic drugs other than solifenacin or treatment for overactive bladder with other drugs
  • Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

Treatment and study plan

solifenacin

Drug

oral

Other names: YM905, Vesicare

Primary outcomes

  1. percentage of patients who are maintaining solifenacin treatment

    Time frame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12

Secondary outcomes

  1. percentage of patients who discontinued solifenacin treatment

    Time frame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12

  2. percentage of patients who switched to other OAB medication

    Time frame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Korea, Inc.

Registry information

Official study title

Persistence of Solifenacin Treatment in Overactive Bladder Patients in Real Life Practice: A 12-month, Prospective, Multicenter, Open-label, Observational Study

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 28, 2009
Registry last updated
Oct 12, 2011

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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