- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04094753
Think Dry: Optimalisation of Diagnostic Process of Urinary Incontinence in Older People
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kim Pauwaert, MD
- Phone Number: +32 093321182
- Email: kim.pauwaert@uzgent.be
Study Contact Backup
- Name: Veerle Decalf
- Phone Number: +32 09332 2207
- Email: veerle.decalf@uzgent.be
Study Locations
-
-
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Gent, Belgium, 8300
- Recruiting
- Department of Urology, Ghent University Hospital
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Principal Investigator:
- Karel Everaert, MD, PhD
-
Contact:
- Kim Pauwaert, MD
- Phone Number: 093321182
- Email: kim.pauwaert@uzgent.be
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Contact:
- Veerle Decalf
- Phone Number: 093322207
- Email: veerle.decalf@uzgent.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decreasing the amount of necessary technical investigations to diagnose incontinence
Time Frame: 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.
|
1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Elimination Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Urinary Incontinence
- Enuresis
- Urinary Incontinence, Stress
- Urinary Incontinence, Urge
- Nocturnal Enuresis
- Diurnal Enuresis
Other Study ID Numbers
- EC/2013/950
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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