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Completed

NCT Number: NCT01122550

Reproducibility Study of Overactive Bladder Symptom Score [OABSS]

The purpose of this study is to evaluate its reproducibility of overactive bladder symptom score (OABSS) and to evaluate its correlation to other measures of OAB symptoms.

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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 1 urgency episode in last 3 days
  • Symptoms of OAB as verified by 3-day micturition diary prior to Visit 1, defined by:
  • Number of micturition per day ≥8
  • Number of urgency episodes in 3 days ≥1

Exclusion criteria

  • Significant stress incontinence or mixed stress/urge incontinence
  • Subjects with indwelling catheters or practicing intermittent self-catheterization
  • Symptomatic urinary tract infection, chronic inflammation
  • Diabetic neuropathy
  • Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks
  • Participation in any clinical trial in 30 days

Treatment and study plan

Primary outcomes

  1. OABSS

    Time frame: Weeks 0 and 2

Secondary outcomes

  1. International Prostate Symptom Score (IPSS)

    Time frame: Weeks 0 and 2

  2. Quality of Life (QOL) score

    Time frame: Weeks 0 and 2

  3. Patient Perception of Bladder Condition (PPBC)

    Time frame: Weeks 0 and 2

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 1: Reproducibility -

Acronym: RESORT-1

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 13, 2010
Registry last updated
Aug 24, 2010

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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