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

Completed

• Conditions: Urinary Incontinence; Overactive Bladder
• Interventions: Diagnostic Test: Urodynamic Study; Diagnostic Test: OABSS questionnaire fulfilment; Diagnostic Test: UDI-6 questionnaire fulfilment; Diagnostic Test: IIQ-7 questionnaire fulfilment

• Registration Number: NCT03801239
• Lead Sponsor: Medical University of Lublin

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

Detailed 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.

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-09
• Last Update Submitted: 2019-01-09
• Study First Posted: 2019-01-11
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 822

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with Overactive Bladder (OAB)	Urodynamic Study	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 Overactive Bladder (OAB)	OABSS questionnaire fulfilment	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 Overactive Bladder (OAB)	IIQ-7 questionnaire fulfilment	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)	Urodynamic Study	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 Overactive Bladder (OAB)	UDI-6 questionnaire fulfilment	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)	OABSS questionnaire fulfilment	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)	UDI-6 questionnaire fulfilment	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)	IIQ-7 questionnaire fulfilment	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)	Urodynamic Study	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)	UDI-6 questionnaire fulfilment	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)	IIQ-7 questionnaire fulfilment	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)	OABSS questionnaire fulfilment	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.

Primary Outcome Measures

Name	Time	Method
Correlation of OABSS questionnaire and Urodynamic study	2 weeks	Results of polish version of OABSS are correlated with Urodynamic study results

Secondary Outcome Measures

Name	Time	Method
Correlation of OABSS questionnaire with UDI-6 results	2 weeks	Results of polish version of OABSS are correlated with UDI-6 results
Correlation of OABSS questionnaire with IIQ-7 results	2 weeks	Results of polish version of OABSS are correlated with IIQ-7 results

Trial Locations

Locations (1)

Medical University of Lublin; 🇵🇱 Lublin, Lubelskie, Poland