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

NCT ID: NCT04094753

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2024-08-01

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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Blood Sample

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Frequency Volume Chart

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

Intervention Type DIAGNOSTIC_TEST

Cystometry

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

Intervention Type 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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Clinical Examination

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

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Urology, Ghent University Hospital

Ghent, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Kim Pauwaert, MD

Role: CONTACT

+32 093321182

Veerle Decalf

Role: CONTACT

+32 09332 2207

Facility Contacts

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Kim Pauwaert, MD

Role: primary

093321182

Veerle Decalf

Role: backup

093322207

Other Identifiers

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EC/2013/950

Identifier Type: -

Identifier Source: org_study_id

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