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Completed

NCT Number: NCT01318837

A Study to Evaluate Response of Over Active Bladder Symptom Score to Solifenacin Treatment

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

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Key information

Conditions

Over Active Bladder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul, 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

  • Symptoms of OAB for 3 months or longer
  • At least 1 urgency episode in last 3 days
  • Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
  • a. Number of micturition ≥8 times/day
  • b. 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
  • Diabetic neuropathy

Treatment and study plan

solifenacin

Drug

oral

Other names: Vesicare

Primary outcomes

  1. Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS)

    Time frame: week 0 (baseline) and week 4

  2. Changes from baseline to week 12 in OABSS

    Time frame: week 0 (baseline) and week 12

Secondary outcomes

  1. Changes from baseline in International Prostate Symptom Score (IPSS) at week 4

    Time frame: week 0 (baseline) and week 4

  2. Changes from baseline in IPSS at week 12

    Time frame: week 0 (baseline) and week 12

  3. Changes from baseline in Quality of Life (QoL) Score at week 4

    Time frame: week 0 (baseline) and week 4

  4. Changes from baseline in QoL Score at week 12

    Time frame: week 0 (baseline) and week 12

  5. Changes from baseline in Patient Perception of Bladder Condition (PPBC) at week 4

    Time frame: week 0 (baseline) and week 4

  6. Changes from baseline in PPBC at week 12

    Time frame: week 0 (baseline) and week 12

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Korea, Inc.

Registry information

Official study title

Reproducibility Study of OABSS and Its Response to Solifenacin Treatment (RESORT) and Validity in Korean Populations; Part 2: Responsiveness and Validity

Acronym: RESORT-2

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 21, 2011
Registry last updated
Jul 10, 2014

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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