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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04094753
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

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
Incontinence, Urge Incontinence Stress Incontinence, Daytime Urinary Incontinence, Nighttime Urinary 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

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Study Type : Observational
Estimated 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 : January 1, 2014
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Blood Sample
    A sober blood sample is taken to observe the following parameters: creatinin, ureum, sodium, potassium, osmolality, HDL cholesterol, LDL cholesterol, triglycerides)
  • Diagnostic Test: Renal Function Profile
    A Renal Function Profile is a 24 hour-urine collection in which urine samples are collected at fixed time points every 3 hours, starting 3 hours after the first morning void. Daytime samples were taken at 10:00-11:30 (U1), 13:00-15:30 (U2), 16:00-17:30 (U3), 19:00-20:30 (U4), and 22:00-23:30 (U5). The nighttime samples were taken at 1:00-2:30 (U6), 4:00-5:30 (U7) and 7:00-8:30 (U8). The volume of each sample, and of each micturition in between, was noted to calculate the 24h, daytime and nighttime urine volume and diuresis rate.
  • Diagnostic Test: Frequency Volume Chart
    Every patient complets a frequency volume chart during 24 of 72 hours
  • Diagnostic Test: Cystometry
    This technique provide the most precise measurement of bladder and urethral sphincter behaviour during bladder filling and during voiding.
  • Diagnostic Test: Questionaires

    Patients have to fulfill the following questionaires

    • ICIQ-Fluts for female participants or ICIQ-Mluts for male participants
    • TILBURG FRAILTY INDICATOR
    • SF-36 Quality of Life score
    • N- QOL
  • Diagnostic Test: Flow rate measurement + Observation of the post-void residual urine volume
    A measurement of the urinary flow rate is observed to collect the maximum Q/s. Afterwards an observation of the PVR is done using ultrasound.
  • Diagnostic Test: Clinical Examination
    Clinical examination of the genital region. For women, coeles are described using the POPQ


Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Older, cognitive intact people (>= 65 years) of both sexes with all types of urinary incontinence
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04094753


Contacts
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Contact: Kim Pauwaert, MD +32 093321182 kim.pauwaert@uzgent.be
Contact: Veerle Decalf +32 09332 2207 veerle.decalf@uzgent.be

Locations
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Belgium
Department of Urology, Ghent University Hospital Recruiting
Gent, Belgium, 8300
Contact: Kim Pauwaert, MD    093321182    kim.pauwaert@uzgent.be   
Contact: Veerle Decalf    093322207    veerle.decalf@uzgent.be   
Principal Investigator: Karel Everaert, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT04094753    
Other Study ID Numbers: EC/2013/950
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Urge
Urinary Incontinence, Stress
Nocturnal Enuresis
Diurnal Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders