Clinical trial NCT04433715: Identification of the UDI-6 and the IIQ-7 Cutoff Scores in Urinary Incontinent Women
Official title: Identification of the Urogenital Distress Inventory-6 and the Incontinence Impact Questionnaire-7 Cutoff Scores in Urinary Incontinent Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Urinary Incontinence,Stress
Urinary Incontinence
Keywords: Incontinence Impact Questionnaire-7
Urogenital Distress Inventory-6
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 155
Sex: FEMALE
Minimum age (years): 31
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study involved a total of 205 women aged between 31 and 83 years who were recruited from women attending the Gynecological Outpatient Clinic due to UI symptoms.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* UI symptoms

Exclusion Criteria:

* lack of consent, oncological diseases

Primary outcomes:
measure: patients with sympthomatic UI- ICIQ-SF ≥6
timeFrame: 01.03.2016-30.06.2016
measure: asymphomatic patients ICIQ-SF<6
timeFrame: 01.03.2016-30.06.2016
Secondary outcomes:
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: Katarzyna Skorupska
Study officials:
affiliation: Medical University of Lublin
name: Tomasz Rechberger
role: STUDY_DIRECTOR
References:
citation: 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.