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

Incontinence, Urge Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04094753
• Other study ID #: EC/2013/950
• Status: Recruiting
• Start date: January 1, 2014
• Est. completion date: August 1, 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Ghent
• Contact: Kim Pauwaert, MD
• Phone: +32 093321182
• Email: kim.pauwaert[@]uzgent.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diurnal Enuresis
• Enuresis
• Incontinence Stress
• Incontinence, Daytime Urinary
• Incontinence, Nighttime Urinary
• Incontinence, Urge
• Nocturnal Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence, Urge

Intervention

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)
• 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.
• Frequency Volume Chart
Every patient complets a frequency volume chart during 24 of 72 hours
• Cystometry
This technique provide the most precise measurement of bladder and urethral sphincter behaviour during bladder filling and during voiding.
• 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
• 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.
• Clinical Examination
Clinical examination of the genital region. For women, coeles are described using the POPQ

Locations

Country	Name	City	State
Belgium	Department of Urology, Ghent University Hospital	Gent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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