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

NCT ID: NCT04433715

Last Updated: 2020-06-16

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

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-01

Study Completion Date

2016-07-01

Brief Summary

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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

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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

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Quality of Life Urinary Incontinence,Stress Urinary Incontinence

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with UI symptoms

All participants completed all three questionnaires: ICIQ-SF, UDI-6 and IIQ-7.

ICIQ-SF

Intervention Type DIAGNOSTIC_TEST

All participants completed ICIQ-SF,

UDI-6

Intervention Type DIAGNOSTIC_TEST

All participants completed UDI-6

IIQ-7

Intervention Type DIAGNOSTIC_TEST

All participants completed IIQ-7

patients without UI symptoms

All participants completed all three questionnaires: ICIQ-SF, UDI-6 and IIQ-7.

ICIQ-SF

Intervention Type DIAGNOSTIC_TEST

All participants completed ICIQ-SF,

UDI-6

Intervention Type DIAGNOSTIC_TEST

All participants completed UDI-6

IIQ-7

Intervention Type DIAGNOSTIC_TEST

All participants completed IIQ-7

Interventions

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ICIQ-SF

All participants completed ICIQ-SF,

Intervention Type DIAGNOSTIC_TEST

UDI-6

All participants completed UDI-6

Intervention Type DIAGNOSTIC_TEST

IIQ-7

All participants completed IIQ-7

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* UI symptoms

Exclusion Criteria

* lack of consent, oncological diseases
Minimum Eligible Age

31 Years

Maximum Eligible Age

83 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Lublin

OTHER

Sponsor Role lead

Responsible Party

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Katarzyna Skorupska

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tomasz Rechberger

Role: STUDY_DIRECTOR

Medical University of Lublin

Locations

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Katarzyna Skorupska

Lublin, , Poland

Site Status

Countries

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Poland

References

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Skorupska K, Grzybowska ME, Kubik-Komar A, Rechberger T, Miotla P. Identification of the Urogenital Distress Inventory-6 and the Incontinence Impact Questionnaire-7 cutoff scores in urinary incontinent women. Health Qual Life Outcomes. 2021 Mar 16;19(1):87. doi: 10.1186/s12955-021-01721-z.

Reference Type DERIVED
PMID: 33726776 (View on PubMed)

Other Identifiers

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01/2020

Identifier Type: -

Identifier Source: org_study_id

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