Incontinence, UrgeNCT04094753
Think Dry: Optimalisation of Diagnostic Process of Urinary Incontinence in Older People
An observational study of Incontinence, Urge and Incontinence Stress, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Incontinence, Urge, Incontinence Stress, Incontinence, Daytime Urinary
- What is being tested?
- Blood Sample, Renal Function Profile and Frequency Volume Chart
- How many people
- 202 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2014to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older, cognitive intact people (>= 65 years) of both sexes with all types of urinary incontinence
Who may be able to join
- >= 65 years
- Every type of incontinence: stress, urge, mixed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Department of Urology, Ghent University Hospital
Ghent, 8300
Kim Pauwaert, MD, 093321182, kim.pauwaert@uzgent.be
Veerle Decalf, 093322207, veerle.decalf@uzgent.be
About this study
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
- Being tested
- Blood Sample, Renal Function Profile, Frequency Volume Chart, Cystometry, Questionaires
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Incontinence, Stress, Diurnal Enuresis, Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SampleDiagnostic test
A sober blood sample is taken to observe the following parameters: creatinin, ureum, sodium, potassium, osmolality, HDL cholesterol, LDL cholesterol, triglycerides)
Renal Function ProfileDiagnostic 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 ChartDiagnostic test
Every patient complets a frequency volume chart during 24 of 72 hours
CystometryDiagnostic test
This technique provide the most precise measurement of bladder and urethral sphincter behaviour during bladder filling and during voiding.
QuestionairesDiagnostic 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 volumeDiagnostic 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 ExaminationDiagnostic test
Clinical examination of the genital region. For women, coeles are described using the POPQ
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Jan 2014
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incontinence, UrgeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094753
- Sponsor's protocol ID
- EC/2013/950
- Status last verified
- Jan 2024
- First submitted
- 13 Aug 2019
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Think Dry: Optimalisation of Diagnostic Process of Urinary Incontinence in Older People
- ClinicalTrials.gov ID
- NCT04094753
- Acronym / sponsor ID
- EC/2013/950
- Conditions
- Incontinence, Urge, Incontinence Stress, Incontinence, Daytime Urinary, Incontinence, Nighttime Urinary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older, cognitive intact people (>= 65 years) of both sexes with all types of urinary incontinence
Key inclusion criteria (2 listed)
- >= 65 years
- Every type of incontinence: stress, urge, mixed.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood SampleA sober blood sample is taken to observe the following parameters: creatinin, ureum, sodium, potassium, osmolality, HDL cholesterol, LDL cholesterol, triglycerides) | Diagnostic test | – |
| Renal Function ProfileA 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 ChartEvery patient complets a frequency volume chart during 24 of 72 hours | Diagnostic test | – |
| CystometryThis technique provide the most precise measurement of bladder and urethral sphincter behaviour during bladder filling and during voiding. | Diagnostic test | – |
| QuestionairesPatients 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 volumeA 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 ExaminationClinical examination of the genital region. For women, coeles are described using the POPQ | Diagnostic test | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incontinence, Urge and Incontinence Stress, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim Pauwaert, MD (+32 093321182, kim.pauwaert@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreasing the amount of necessary technical investigations to diagnose incontinence (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.