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

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

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

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Urinary Incontinence
• Intervention / Treatment: Diagnostic test: Urodynamic Study; Diagnostic test: OABSS questionnaire fulfilment; Diagnostic test: UDI-6 questionnaire fulfilment; Diagnostic test: IIQ-7 questionnaire fulfilment

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 Type: Observational
• Enrollment (Actual): 822

Contacts and Locations

Study Locations

• Poland
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-954
      • Medical University of Lublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Urodynamic Study; during visit Week 0 patients had urodynamic study; Diagnostic test: OABSS questionnaire fulfilment; during visit Week 0 and Week 2 patients fulfilled OABSS; Diagnostic test: UDI-6 questionnaire fulfilment; during visit Week 2 patients fulfilled UDI-6 questionnaire; Diagnostic test: IIQ-7 questionnaire fulfilment; during visit Week 2 patients fulfilled IIQ-7 questionnaire
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.	Diagnostic test: Urodynamic Study; during visit Week 0 patients had urodynamic study; Diagnostic test: OABSS questionnaire fulfilment; during visit Week 0 and Week 2 patients fulfilled OABSS; Diagnostic test: UDI-6 questionnaire fulfilment; during visit Week 2 patients fulfilled UDI-6 questionnaire; Diagnostic test: IIQ-7 questionnaire fulfilment; during visit Week 2 patients fulfilled IIQ-7 questionnaire
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.	Diagnostic test: Urodynamic Study; during visit Week 0 patients had urodynamic study; Diagnostic test: OABSS questionnaire fulfilment; during visit Week 0 and Week 2 patients fulfilled OABSS; Diagnostic test: UDI-6 questionnaire fulfilment; during visit Week 2 patients fulfilled UDI-6 questionnaire; Diagnostic test: IIQ-7 questionnaire fulfilment; during visit Week 2 patients fulfilled IIQ-7 questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of OABSS questionnaire and Urodynamic study	Results of polish version of OABSS are correlated with Urodynamic study results	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of OABSS questionnaire with UDI-6 results	Results of polish version of OABSS are correlated with UDI-6 results	2 weeks
Correlation of OABSS questionnaire with IIQ-7 results	Results of polish version of OABSS are correlated with IIQ-7 results	2 weeks

Collaborators and Investigators

• Sponsor: Medical University of Lublin

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Actual): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 9, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Bladder, Overactive; Urinary Incontinence
• Other Study ID Numbers: 01/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No