Clinical trial NCT02667470: Reproducibility Study of OABSS and Its Response to Treatment
Official title: Overactive Bladder Symptom Scores (OABSS) Responsiveness Before and After Anticholinergic Treatment in Women With Overactive Bladder (OAB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: Solifenacin
Overactive bladder
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2016-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in OABSS scores from prior to treatment and after treatment
timeFrame: Prior to treatment and after treatment (up to 12 weeks)
Secondary outcomes:
measure: Correlation of change between OABSS scores and number of micturitions per day
timeFrame: Prior to treatment and after treatment (up to 12 weeks)
measure: Correlation of change between OABSS scores and number of incontinence episodes per day
timeFrame: Prior to treatment and after treatment (up to 12 weeks)
measure: Correlation of change between OABSS scores and number of urgency episodes per day
timeFrame: Prior to treatment and after treatment (up to 12 weeks)
measure: Correlation of change between OABSS scores and number of nocturia episodes per day
timeFrame: Prior to treatment and after treatment (up to 12 weeks)
measure: Correlation of change between OABSS scores and number of total voided volume per day
timeFrame: Prior to treatment and after treatment (up to 12 weeks)
measure: Correlation of change between OABSS scores and number of pads per day
timeFrame: Prior to treatment and after treatment (up to 12 weeks)
measure: Correlation of change between OABSS scores and total International Prostate Symptom Score (IPSS) score
timeFrame: Prior to treatment and after treatment (up to 12 weeks)
measure: Correlation of change between OABSS scores and IPSS Quality of Life (QoL) score
timeFrame: Prior to treatment and after treatment (up to 12 weeks)
measure: Correlation of change between OABSS scores and Patient Perception of Bladder Condition (PPBC) total score
timeFrame: Prior to treatment and after treatment (up to 12 weeks)
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Site: 1
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: