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OpenTrials
Completed

NCT Number: NCT02667470

Reproducibility Study of OABSS and Its Response to Treatment

The objective of this study is to evaluate change of Overactive Bladder (OAB) Symptom Score (OABSS) scores between before and after Solifenacin treatment to OAB patients and to evaluate correlation between change of OABSS scores and other measures for 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

Interventional

Phase

Phase 4

Primary location

Site: 1

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At screening visit (Week -2):
  • Symptoms of OAB ≥ 3 months
  • Number of urgency episodes in last 3 days ≥ 3
  • Based on the 3-day micturition diary prior to Visit 1 (Week 0):
  • Number of micturition per day ≥ 8
  • Number of urgency episodes in 3 days ≥ 3

Exclusion criteria

  • At screening visit (Week -2):
  • Stress is the predominant factor as determined by the investigator
  • Indwelling catheters or practicing intermittent self-catheterization
  • Symptomatic urinary tract infection, chronic inflammation
  • Treatment for OAB was started, quitted or changed in 4 weeks
  • Diabetic neuropathy
  • At Visit 1 (Week 0):
  • Patient who did not complete the 3-day micturition diary according to the instruction

Treatment and study plan

solifenacin

Drug

Oral

Other names: Vesicare

Primary outcomes

  1. Change in OABSS scores from prior to treatment and after treatment

    Time frame: Prior to treatment and after treatment (up to 12 weeks)

Secondary outcomes

  1. Correlation of change between OABSS scores and number of micturitions per day

    Time frame: Prior to treatment and after treatment (up to 12 weeks)

  2. Correlation of change between OABSS scores and number of incontinence episodes per day

    Time frame: Prior to treatment and after treatment (up to 12 weeks)

  3. Correlation of change between OABSS scores and number of urgency episodes per day

    Time frame: Prior to treatment and after treatment (up to 12 weeks)

  4. Correlation of change between OABSS scores and number of nocturia episodes per day

    Time frame: Prior to treatment and after treatment (up to 12 weeks)

  5. Correlation of change between OABSS scores and number of total voided volume per day

    Time frame: Prior to treatment and after treatment (up to 12 weeks)

  6. Correlation of change between OABSS scores and number of pads per day

    Time frame: Prior to treatment and after treatment (up to 12 weeks)

  7. Correlation of change between OABSS scores and total International Prostate Symptom Score (IPSS) score

    Time frame: Prior to treatment and after treatment (up to 12 weeks)

  8. Correlation of change between OABSS scores and IPSS Quality of Life (QoL) score

    Time frame: Prior to treatment and after treatment (up to 12 weeks)

  9. Correlation of change between OABSS scores and Patient Perception of Bladder Condition (PPBC) total score

    Time frame: Prior to treatment and after treatment (up to 12 weeks)

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Overactive Bladder Symptom Scores (OABSS) Responsiveness Before and After Anticholinergic Treatment in Women With Overactive Bladder (OAB)

Acronym: RESORT part 2

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 29, 2016
Registry last updated
Jan 29, 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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