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

NCT04433715 | Completed

• 1 other identifier: 01/2020
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Urinary Incontinence,Stress; Urinary Incontinence

Keywords

Incontinence Impact Questionnaire-7; Urogenital Distress Inventory-6

Outcome Measures

Primary Outcomes (2)

• patients with sympthomatic UI- ICIQ-SF ≥6

  symptomatic ICIQ-SF ≥6

  01.03.2016-30.06.2016

• asymphomatic patients ICIQ-SF<6

  ICIQ\<6

  01.03.2016-30.06.2016

Study Arms (2)

patients with UI symptoms

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

Diagnostic Test: ICIQ-SF; Diagnostic Test: UDI-6; Diagnostic Test: IIQ-7

patients without UI symptoms

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

Diagnostic Test: ICIQ-SF; Diagnostic Test: UDI-6; Diagnostic Test: IIQ-7

Interventions

ICIQ-SF DIAGNOSTIC_TEST

All participants completed ICIQ-SF,

patients with UI symptoms; patients without UI symptoms

UDI-6 DIAGNOSTIC_TEST

All participants completed UDI-6

patients with UI symptoms; patients without UI symptoms

IIQ-7 DIAGNOSTIC_TEST

All participants completed IIQ-7

patients with UI symptoms; patients without UI symptoms

Eligibility Criteria

• Age: 31 Years - 83 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• UI symptoms

You may not qualify if:

• lack of consent, oncological diseases

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

Katarzyna Skorupska

Lublin, 20-059, Poland

Location

Related Publications (1)

• 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.

  PMID: 33726776 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tomasz Rechberger

  Medical University of Lublin

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: March 1, 2016
• Primary Completion: June 30, 2016
• Study Completion: July 1, 2016
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2020
• Access Criteria: email co PI kasiaperzylo@hotmail.com

Locations

PL (1)