Reproducibility Study of OABSS and Its Response to Treatment

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02667470

Acronym

RESORT part 2

Enrollment

Registered

2016-01-29

Start date

2009-09-30

Completion date

2013-05-31

Last updated

2016-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

Solifenacin, Overactive bladder

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.

Interventions

DRUGSolifenacin

Oral

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in OABSS scores from prior to treatment and after treatment	Prior to treatment and after treatment (up to 12 weeks)

Secondary

Measure	Time frame
Correlation of change between OABSS scores and number of incontinence episodes per day	Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of urgency episodes per day	Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of nocturia episodes per day	Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of total voided volume per day	Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of micturitions per day	Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and total International Prostate Symptom Score (IPSS) score	Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and IPSS Quality of Life (QoL) score	Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and Patient Perception of Bladder Condition (PPBC) total score	Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of pads per day	Prior to treatment and after treatment (up to 12 weeks)

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026