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

NCT04094753 | Unknown

• 1 other identifier: EC/2013/950
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Blood Sample DIAGNOSTIC_TEST

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

Renal Function Profile DIAGNOSTIC_TEST

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 DIAGNOSTIC_TEST

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

Cystometry DIAGNOSTIC_TEST

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

Questionaires DIAGNOSTIC_TEST

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 DIAGNOSTIC_TEST

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 DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older, cognitive intact people (\>= 65 years) of both sexes with all types of urinary incontinence

You may qualify if:

• \>= 65 years
• Every type of incontinence: stress, urge, mixed.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Department of Urology, Ghent University Hospital

Ghent, 8300, Belgium

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Incontinence, Stress; Diurnal Enuresis; Nocturnal Enuresis

Interventions

Blood Specimen Collection; Physical Examination

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Enuresis; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Kim Pauwaert, MD

CONTACT

+32 093321182; kim.pauwaert@uzgent.be

Veerle Decalf

CONTACT

+32 09332 2207; veerle.decalf@uzgent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: September 19, 2019
• Study Start: January 1, 2014
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

BE (1)