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

NCT ID: NCT03801239

Last Updated: 2019-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

822 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Overactive Bladder Urinary Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Urodynamic Study

Intervention Type DIAGNOSTIC_TEST

during visit Week 0 patients had urodynamic study

OABSS questionnaire fulfilment

Intervention Type DIAGNOSTIC_TEST

during visit Week 0 and Week 2 patients fulfilled OABSS

UDI-6 questionnaire fulfilment

Intervention Type DIAGNOSTIC_TEST

during visit Week 2 patients fulfilled UDI-6 questionnaire

IIQ-7 questionnaire fulfilment

Intervention Type DIAGNOSTIC_TEST

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.

Urodynamic Study

Intervention Type DIAGNOSTIC_TEST

during visit Week 0 patients had urodynamic study

OABSS questionnaire fulfilment

Intervention Type DIAGNOSTIC_TEST

during visit Week 0 and Week 2 patients fulfilled OABSS

UDI-6 questionnaire fulfilment

Intervention Type DIAGNOSTIC_TEST

during visit Week 2 patients fulfilled UDI-6 questionnaire

IIQ-7 questionnaire fulfilment

Intervention Type DIAGNOSTIC_TEST

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.

Urodynamic Study

Intervention Type DIAGNOSTIC_TEST

during visit Week 0 patients had urodynamic study

OABSS questionnaire fulfilment

Intervention Type DIAGNOSTIC_TEST

during visit Week 0 and Week 2 patients fulfilled OABSS

UDI-6 questionnaire fulfilment

Intervention Type DIAGNOSTIC_TEST

during visit Week 2 patients fulfilled UDI-6 questionnaire

IIQ-7 questionnaire fulfilment

Intervention Type DIAGNOSTIC_TEST

during visit Week 2 patients fulfilled IIQ-7 questionnaire

Interventions

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Urodynamic Study

during visit Week 0 patients had urodynamic study

Intervention Type DIAGNOSTIC_TEST

OABSS questionnaire fulfilment

during visit Week 0 and Week 2 patients fulfilled OABSS

Intervention Type DIAGNOSTIC_TEST

UDI-6 questionnaire fulfilment

during visit Week 2 patients fulfilled UDI-6 questionnaire

Intervention Type DIAGNOSTIC_TEST

IIQ-7 questionnaire fulfilment

during visit Week 2 patients fulfilled IIQ-7 questionnaire

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lublin

OTHER

Sponsor Role lead

Responsible Party

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Andrzej Wróbel

PhD, MD associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Lublin

Lublin, Lublin Voivodeship, Poland

Site Status

Countries

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Poland

Other Identifiers

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01/2019

Identifier Type: -

Identifier Source: org_study_id

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