NCT04619238

Brief Summary

The aim of this study was to assess the psychometric properties of KHQ and ICIQ-SF in polish women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

1.6 years

First QC Date

November 2, 2020

Last Update Submit

November 5, 2020

Conditions

Urinary IncontinenceOveractive BladderStress Urinary IncontinenceUrge Incontinence

Keywords

king's health questionnairethe International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form

Outcome Measures

Primary Outcomes (2)

  • psychometric properties of KHQ in polish women with urinary incontinence

    psychometric properties of KHQ

    2017-2018

  • psychometric properties of ICIQ-SF in polish women with urinary incontinence

    psychometric properties of ICIQ-SF

    2017-2018

Study Arms (5)

no urinary incontinence

patients without UI

Diagnostic Test: King's Health QuestionnaireDiagnostic Test: the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form

stress urinary incontinence

patients with SUI

Diagnostic Test: King's Health QuestionnaireDiagnostic Test: the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form

overactive bladder

patients with OAB

Diagnostic Test: King's Health QuestionnaireDiagnostic Test: the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form

mix urinary incontinence

patients with MUI

Diagnostic Test: King's Health QuestionnaireDiagnostic Test: the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form

Urge

patients with urge incontinence

Diagnostic Test: King's Health QuestionnaireDiagnostic Test: the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form

Interventions

King's Health QuestionnaireDIAGNOSTIC_TEST

patients fulfilled questionnaire

Urgemix urinary incontinenceno urinary incontinenceoveractive bladderstress urinary incontinence
the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short FormDIAGNOSTIC_TEST

patients fulfilled ICIQ-SF questionnaire

Urgemix urinary incontinenceno urinary incontinenceoveractive bladderstress urinary incontinence

Eligibility Criteria

Age18 Years - 82 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

women age 18-82 years who declared symptoms of urinary incontinence

You may qualify if:

  • informed consent
  • patients with symptoms of urinary incontinence
  • age 18-82 years

You may not qualify if:

  • lack of consent
  • inability to understand the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katarzyna Skorupska

Lublin, 20-059, Poland

Location

MeSH Terms

Conditions

Urinary IncontinenceUrinary Bladder, OveractiveUrinary Incontinence, StressUrinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary Bladder Diseases

Study Officials

  • Tomasz Rechberger, Professor

    Medical University of Lublin

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 6, 2020

Study Start

June 1, 2017

Primary Completion

December 30, 2018

Study Completion

January 10, 2019

Last Updated

November 6, 2020

Record last verified: 2020-11

Locations

PL(1)