Think Dry: Optimalisation of Diagnostic Process of Urinary Incontinence in Older People
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|ClinicalTrials.gov Identifier: NCT04094753|
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
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|
|Study Type :||Observational|
|Estimated Enrollment :||202 participants|
|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|
- 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
- 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.
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
|Contact: Kim Pauwaert, MD||+32 email@example.com|
|Contact: Veerle Decalf||+32 09332 firstname.lastname@example.org|