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NCT04433715 Clinical Trial

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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04433715
Other study ID # 01/2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2016
Est. completion date July 1, 2016

Study information
Verified date June 2020
Source Medical University of Lublin
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 155
Est. completion date July 1, 2016
Est. primary completion date June 30, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 31 Years to 83 Years
Eligibility Inclusion Criteria:

- UI symptoms

Exclusion Criteria:

- lack of consent, oncological diseases

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• ICIQ-SF
All participants completed ICIQ-SF,
• UDI-6
All participants completed UDI-6
• IIQ-7
All participants completed IIQ-7

Locations
Country Name City State
Poland Katarzyna Skorupska Lublin

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary patients with sympthomatic UI- ICIQ-SF =6 symptomatic ICIQ-SF =6 01.03.2016-30.06.2016
Primary asymphomatic patients ICIQ-SF<6 ICIQ<6 01.03.2016-30.06.2016
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