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NCT03801239 Clinical Trial

Reliability of Polish-Version Overactive Bladder Syndrom Scores (OABSS)

Urinary Incontinence Clinical Trial

Official title:
Reliability of Polish-Version Overactive Bladder Syndrom Scores (OABSS) Questionnaire and the Correlation of OABSS With the Results of UDI-6 and IIQ-7 Questionnaires

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03801239
Other study ID # 01/2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2017
Est. completion date December 31, 2018

Study information
Verified date January 2019
Source Medical University of Lublin
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Description:

The translation into Polish followed standardized procedures. Women aged between 18-75 years were included into the study. 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 (confirmed by medical history, and urodynamic investigation). All 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.

Recruitment information / eligibility
Status Completed
Enrollment 822
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- confirmed Urinary Incontinence in Urodynamic study (SUI, OAB, MUI)

- female aged 18-75 years old

Exclusion Criteria:

- malignant disorders

- uncontrolled diabetes

- inability to understand informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Urodynamic Study
during visit Week 0 patients had urodynamic study
• OABSS questionnaire fulfilment
during visit Week 0 and Week 2 patients fulfilled OABSS
• UDI-6 questionnaire fulfilment
during visit Week 2 patients fulfilled UDI-6 questionnaire
• IIQ-7 questionnaire fulfilment
during visit Week 2 patients fulfilled IIQ-7 questionnaire

Locations
Country Name City State
Poland Medical University of Lublin Lublin Lubelskie

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation of OABSS questionnaire and Urodynamic study Results of polish version of OABSS are correlated with Urodynamic study results 2 weeks
Secondary Correlation of OABSS questionnaire with UDI-6 results Results of polish version of OABSS are correlated with UDI-6 results 2 weeks
Secondary Correlation of OABSS questionnaire with IIQ-7 results Results of polish version of OABSS are correlated with IIQ-7 results 2 weeks
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