Reliability of Polish-Version Overactive Bladder Syndrom Scores (OABSS)
1 other identifier
observational
822
1 country
1
Brief Summary
The aim of this study was to develop and assess the effectiveness of a Polish version of OABSS and to correlate the OABSS with urodynamic study results and UDI-6, IIQ-7 questionnaires
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFirst Submitted
Initial submission to the registry
January 9, 2019
CompletedFirst Posted
Study publicly available on registry
January 11, 2019
CompletedJanuary 11, 2019
January 1, 2019
1.6 years
January 9, 2019
January 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation of OABSS questionnaire and Urodynamic study
Results of polish version of OABSS are correlated with Urodynamic study results
2 weeks
Secondary Outcomes (2)
Correlation of OABSS questionnaire with UDI-6 results
2 weeks
Correlation of OABSS questionnaire with IIQ-7 results
2 weeks
Study Arms (3)
patients with Overactive Bladder (OAB)
Patients completed the Polish version of the OABSS on two separate visits: Week 0 and Week 2 and additionally UDI-6, IIQ-7 during visit- Week 2.
patients with Mixed Urinary incontinence (MUI)
Patients completed the Polish version of the OABSS on two separate visits: Week 0 and Week 2 and additionally UDI-6, IIQ-7 during visit- Week 2.
patients with Stress Urinary Incontinence (SUI)
Patients completed the Polish version of the OABSS on two separate visits: Week 0 and Week 2 and additionally UDI-6, IIQ-7 during visit- Week 2.
Interventions
during visit Week 0 patients had urodynamic study
during visit Week 0 and Week 2 patients fulfilled OABSS
during visit Week 2 patients fulfilled UDI-6 questionnaire
during visit Week 2 patients fulfilled IIQ-7 questionnaire
Eligibility Criteria
All patients were recruited from women attending the Outpatient Clinic of the 2nd Gynecology Department of the Medical University in Lublin. SUI was observed in 290 cases; OAB in 283 patients and 249 had MUI
You may qualify if:
- confirmed Urinary Incontinence in Urodynamic study (SUI, OAB, MUI)
- female aged 18-75 years old
You may not qualify if:
- malignant disorders
- uncontrolled diabetes
- inability to understand informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Lublin
Lublin, Lublin Voivodeship, 20-954, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, MD associated professor
Study Record Dates
First Submitted
January 9, 2019
First Posted
January 11, 2019
Study Start
June 1, 2017
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
January 11, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share