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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreasing the amount of necessary technical investigations to diagnose incontinence | 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 |