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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01318837

Acronym

RESORT-2

Enrollment

100

Registered

2011-03-21

Start date

2010-04-30

Completion date

2011-09-30

Last updated

2014-07-10

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

Conditions

Over Active Bladder

Keywords

OABSS, IPSS, PPBC, Solifenacin

Brief summary

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

Interventions

DRUGsolifenacin

oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS)	week 0 (baseline) and week 4
Changes from baseline to week 12 in OABSS	week 0 (baseline) and week 12

Secondary

Measure	Time frame
Changes from baseline in Quality of Life (QoL) Score at week 4	week 0 (baseline) and week 4
Changes from baseline in QoL Score at week 12	week 0 (baseline) and week 12
Changes from baseline in International Prostate Symptom Score (IPSS) at week 4	week 0 (baseline) and week 4
Changes from baseline in PPBC at week 12	week 0 (baseline) and week 12
Changes from baseline in Patient Perception of Bladder Condition (PPBC) at week 4	week 0 (baseline) and week 4
Changes from baseline in IPSS at week 12	week 0 (baseline) and week 12

Countries

South Korea

Outcome results

None listed

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