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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04094753
Enrollment
202
Registered
2019-09-19
Start date
2014-01-01
Completion date
2024-08-01
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTCystometry

This technique provide the most precise measurement of bladder and urethral sphincter behaviour during bladder filling and during voiding.

DIAGNOSTIC_TESTBlood Sample

A sober blood sample is taken to observe the following parameters: creatinin, ureum, sodium, potassium, osmolality, HDL cholesterol, LDL cholesterol, triglycerides)

DIAGNOSTIC_TESTRenal 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_TESTFrequency Volume Chart

Every patient complets a frequency volume chart during 24 of 72 hours

DIAGNOSTIC_TESTQuestionaires

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_TESTFlow 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_TESTClinical Examination

Clinical examination of the genital region. For women, coeles are described using the POPQ

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Decreasing the amount of necessary technical investigations to diagnose incontinence1 monthBased 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.

Countries

Belgium

Contacts

Primary ContactKim Pauwaert, MD
kim.pauwaert@uzgent.be+32 093321182
Backup ContactVeerle Decalf
veerle.decalf@uzgent.be+32 09332 2207

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026