Clinical Trials Directory

Trials / Completed

CompletedNCT04433715

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
155 (actual)
Sponsor
Medical University of Lublin · Academic / Other
Sex
Female
Age
31 Years – 83 Years
Healthy volunteers
Accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTICIQ-SFAll participants completed ICIQ-SF,
DIAGNOSTIC_TESTUDI-6All participants completed UDI-6
DIAGNOSTIC_TESTIIQ-7All participants completed IIQ-7

Timeline

Start date
2016-03-01
Primary completion
2016-06-30
Completion
2016-07-01
First posted
2020-06-16
Last updated
2020-06-16

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT04433715. Inclusion in this directory is not an endorsement.