Skip to main content
OpenTrials
Completed

NCT Number: NCT03801239

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Medical University of Lublin

Lublin, Lublin Voivodeship, 20-954, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urodynamic study

Diagnostic Test

during visit Week 0 patients had urodynamic study

OABSS questionnaire fulfilment

Diagnostic Test

during visit Week 0 and Week 2 patients fulfilled OABSS

UDI-6 questionnaire fulfilment

Diagnostic Test

during visit Week 2 patients fulfilled UDI-6 questionnaire

IIQ-7 questionnaire fulfilment

Diagnostic Test

during visit Week 2 patients fulfilled IIQ-7 questionnaire

Primary outcomes

  1. Correlation of OABSS questionnaire and Urodynamic study

    Time frame: 2 weeks

    Results of polish version of OABSS are correlated with Urodynamic study results

Secondary outcomes

  1. Correlation of OABSS questionnaire with UDI-6 results

    Time frame: 2 weeks

    Results of polish version of OABSS are correlated with UDI-6 results

  2. Correlation of OABSS questionnaire with IIQ-7 results

    Time frame: 2 weeks

    Results of polish version of OABSS are correlated with IIQ-7 results

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 11, 2019
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.