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Completed

NCT Number: NCT01122563

A Study to Evaluate Response of Overactive Bladder Symptom Score (OABSS) to Treatment

This study is to evaluate change of overactive bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.

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Key information

Conditions

Overactive Bladder 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 Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bandung, Indonesia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptoms OAB for 3 months or longer
  • At least 3 urgency episode in last 3 days
  • Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
  • Number of micturition ≥8 times/day
  • Number of urgency episodes in 3 days ≥3

Exclusion criteria

  • Significant stress incontinence or mixed stress/urge incontinence
  • Subject with indwelling catheters or practicing intermittent self-catheterization
  • Symptomatic urinary tract infection, chronic inflammation
  • Diabetic neuropathy
  • Subjects who are prohibited from taking solifenacin as contraindications
  • Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks
  • Participation in any clinical trial in 30 days except for Part-1 of RESORT

Treatment and study plan

solifenacin

Drug

oral

Other names: Vesicare

Primary outcomes

  1. OABSS

    Time frame: Weeks 0, 4 and 12

Secondary outcomes

  1. International Prostate Symptom Score (IPSS)

    Time frame: Weeks 0, 4 and 12

  2. Quality of Life (QOL) Score

    Time frame: Weeks 0, 4 and 12

  3. Patient Perception of Bladder Condition (PPBC)

    Time frame: Weeks 0, 4 and 12

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Indonesia Inc.

Registry information

Official study title

Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 2: Responsiveness

Acronym: RESORT-2

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 13, 2010
Registry last updated
Jan 13, 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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