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Completed

NCT Number: NCT04433715

Identification of the UDI-6 and the IIQ-7 Cutoff Scores in Urinary Incontinent Women

Purpose Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7) and The International Consultation on Incontinence (ICIQ-SF) Short Form are used to diagnose individuals with urinary incontinence (UI) and to assess the impact of the dysfunction on patient quality of life. While ICIQ-SF has fixed cutoff values - UDI-6 and IIQ-7 do not. We aimed to find the cutoff scores for UDI-6 and IIQ-7 in women with UI.

Methods The study involved 205 women aged between 31 and 83 years - 155 with, and 50 without UI symptoms. All participants completed all three questionnaires: ICIQ-SF, UDI-6 and IIQ-7. Patients were categorized according to their ICIQ-SF scores, as symptomatic ICIQ-SF ≥6 (n=134) and asymptomatic ICIQ < 6 (n=60). The Receiver Operating Characteristics (ROC) curve was used to test how well UDI-6 allowed a discrimination between patients suffering from UI and those who do not. AUC (Area under Curve) statistic was calculated to measure the UDI-6 and IIQ-7 Total Score efficiency.

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Key information

Conditions

Quality of Life 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 Incontinence Urinary Incontinence, Stress Urinary Incontinence,Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

31 year–83 year

Sex eligibility

Female

Study type

Observational

Primary location

Katarzyna Skorupska

Lublin, 20-059, Poland

About this study

Purpose Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7) and The International Consultation on Incontinence (ICIQ-SF) Short Form are used to diagnose individuals with urinary incontinence (UI) and to assess the impact of the dysfunction on patient quality of life. While ICIQ-SF has fixed cutoff values - UDI-6 and IIQ-7 do not. We aimed to find the cutoff scores for UDI-6 and IIQ-7 in women with UI.

Methods The study involved 205 women aged between 31 and 83 years - 155 with, and 50 without UI symptoms. All participants completed all three questionnaires: ICIQ-SF, UDI-6 and IIQ-7. Patients were categorized according to their ICIQ-SF scores, as symptomatic ICIQ-SF ≥6 (n=134) and asymptomatic ICIQ < 6 (n=60). The Receiver Operating Characteristics (ROC) curve was used to test how well UDI-6 allowed a discrimination between patients suffering from UI and those who do not. AUC (Area under Curve) statistic was calculated to measure the UDI-6 and IIQ-7 Total Score efficiency.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • UI symptoms

Exclusion criteria

  • lack of consent, oncological diseases

Treatment and study plan

ICIQ-SF

Diagnostic Test

All participants completed ICIQ-SF,

UDI-6

Diagnostic Test

All participants completed UDI-6

IIQ-7

Diagnostic Test

All participants completed IIQ-7

Primary outcomes

  1. patients with sympthomatic UI- ICIQ-SF ≥6

    Time frame: 01.03.2016-30.06.2016

    symptomatic ICIQ-SF ≥6

  2. asymphomatic patients ICIQ-SF<6

    Time frame: 01.03.2016-30.06.2016

    ICIQ<6

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Official study title

Identification of the Urogenital Distress Inventory-6 and the Incontinence Impact Questionnaire-7 Cutoff Scores in Urinary Incontinent Women

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 16, 2020
Registry last updated
Jun 16, 2020

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.

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