Reproducibility Study of Overactive Bladder Symptom Score [OABSS]

Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 1: Reproducibility -

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01122550

Acronym

RESORT-1

Enrollment

Registered

2010-05-13

Start date

2009-09-30

Completion date

2010-08-31

Last updated

2010-08-24

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

Conditions

Overactive Bladder

Keywords

OABSS, IPSS, PPBC, 3-day micturition diary

Brief summary

The purpose of this study is to evaluate its reproducibility of overactive bladder symptom score (OABSS) and to evaluate its correlation to other measures of OAB symptoms.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Symptoms OAB for 3 months or longer * At least 1 urgency episode in last 3 days * Symptoms of OAB as verified by 3-day micturition diary prior to Visit 1, defined by: * Number of micturition per day ≥8 * Number of urgency episodes in 3 days ≥1

Exclusion criteria

* Significant stress incontinence or mixed stress/urge incontinence * Subjects with indwelling catheters or practicing intermittent self-catheterization * Symptomatic urinary tract infection, chronic inflammation * Diabetic neuropathy * Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks * Participation in any clinical trial in 30 days

Design outcomes

Primary

Measure	Time frame
OABSS	Weeks 0 and 2

Secondary

Measure	Time frame
International Prostate Symptom Score (IPSS)	Weeks 0 and 2
Quality of Life (QOL) score	Weeks 0 and 2
Patient Perception of Bladder Condition (PPBC)	Weeks 0 and 2

Countries

Indonesia

Outcome results