Identification of the UDI-6 and the IIQ-7 Cutoff Scores i... | NCT04433715

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

NCT04433715

Sponsor

Medical University of Lublin

Status

Completed

Last Update Posted

Jun 16, 2020Actual

Enrollment

155Actual

Phase

Not provided

Conditions

Quality of Life
Urinary Incontinence,Stress
Urinary Incontinence

Interventions

ICIQ-SF
UDI-6
IIQ-7

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2016Actual

Primary Completion Date

Jun 30, 2016Actual

Completion Date

Jul 1, 2016Actual

First Submitted Date

Jun 11, 2020

First Submission Date that Met QC Criteria

Jun 12, 2020

First Posted Date

Jun 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2020

Last Update Posted Date

Jun 16, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Katarzyna Skorupska, Principal Investigator, Medical University of LublinPrincipal Investigator

Lead Sponsor

Medical University of LublinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

155Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ICIQ-SF	Diagnostic Test	All participants completed ICIQ-SF,	patients with UI symptoms patients without UI symptoms

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

UI symptoms

Exclusion Criteria:

lack of consent, oncological diseases

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

31 Years

Maximum Age

83 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tomasz Rechberger	Medical University of Lublin	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Katarzyna Skorupska		Lublin		20-059	Poland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33726776	Derived	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.

ID	Term
D014550	Urinary Incontinence, Stress
D014549	Urinary Incontinence

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications