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Think Dry: Optimalisation of Diagnostic Process of Urinary Incontinence in Older People

Sponsor
University Hospital, Ghent (Other)
Overall Status
Recruiting
CT.gov ID
NCT04094753
Collaborator
(none)
202
Enrollment
1
Location
127
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Urinary incontinence is an increasing medical and socio-economical problem. 44% of the elderly (>65 years) women and 28% of the elderly men suffer from unwilling urine loss. Moreover, this percentages increase with age. Incontinence is a problem with multiple physical, psychological, and financial effects. In addition incontinence has a important impact on the family and healthcare professionals surrounding the elderly.

The problem of urinary incontinence is complex and multifactorial. Moreover, diagnostic guidelines are inconsistent leading to a high amount of technical interventions to diagnose and to specify the type of incontinence.

Aim of this study is to create a short form of necessary technical investigations to diagnose and evaluate urinary incontinence.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Blood Sample
  • Diagnostic Test: Renal Function Profile
  • Diagnostic Test: Frequency Volume Chart
  • Diagnostic Test: Cystometry
  • Diagnostic Test: Questionaires
  • Diagnostic Test: Flow rate measurement + Observation of the post-void residual urine volume
  • Diagnostic Test: Clinical Examination

Study Design

Study Type:
Observational
Anticipated Enrollment :
202 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Think Dry: Optimalisation of Diagnostic Process of Urinary Incontinence in Older People
Actual Study Start Date :
Jan 1, 2014
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Decreasing the amount of necessary technical investigations to diagnose incontinence [1 month]

    Based on international guidelines different technical investigations are used and approved to observe the type of urinary incontinence individually. Nevertheless, based on expert opinion all technical investigations schould be done together. However this combination of different technical investigations (urodynamics, questionaires, voiding dairy and clinical examination) is not evidence based and time consuming. We want to develop a statistical model to decrease the need of technical investigations to obtain a correct diagnose of stress urinary incontinence, urge urinary incontinence or mixed incontinence.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • = 65 years

  • Every type of incontinence: stress, urge, mixed.

Exclusion Criteria:

  • Patients with an indwelling urinary catheter are doing clean intermittent catheterization are excluded from the study protocol

  • Patients with dementia are excluded from the study, based on N-Cog evaluation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Urology, Ghent University Hospital Gent Belgium 8300

Sponsors and Collaborators

  • University Hospital, Ghent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT04094753
Other Study ID Numbers:
  • EC/2013/950
First Posted:
Sep 19, 2019
Last Update Posted:
Jan 24, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Urge
Urinary Incontinence, Stress
Nocturnal Enuresis
Diurnal Enuresis

Study Results

No Results Posted as of Jan 24, 2022