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Trial registered on ANZCTR
Registration number
ACTRN12624000008527
Ethics application status
Approved
Date submitted
4/12/2023
Date registered
9/01/2024
Date last updated
9/01/2024
Date data sharing statement initially provided
9/01/2024
Date results information initially provided
9/01/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Comparison of demographics, clinical symptoms, and urodynamic findings between detrusor overactivity with detrusor underactivity patients under the age of 70 and those aged 70 or older
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Scientific title
Comparison of demographics, clinical symptoms, and urodynamic findings between detrusor overactivity with detrusor underactivity patients under the age of 70 and those aged 70 or older
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Secondary ID [1]
311092
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
detrusor overactivity with detrusor underactivity
332245
0
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Condition category
Condition code
Surgery
328960
328960
0
0
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Other surgery
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Renal and Urogenital
329073
329073
0
0
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This research retrospectively attempts to compare demographic characteristics, clinical presentations, and urodynamic findings between two age groups of detrusor overactivity with detrusor underactivity (DO-DU) patients: those younger than 70 years and those aged 70 years or older. This research is collecting data using a retrospective approach from medical records, absent any direct patient involvement. An approximate total of 250 patients diagnosed with DO-DU, who underwent multichannel urodynamic testing at a single center from 2012 to 2023, were included in this study. Patients were divided into two groups: the “Younger” group (aged less than 70 years) and the “Older” group (aged 70 years or older). We compared demographics, number of risk factors considered to affect bladder function, clinical presentations, and urodynamic findings between these two groups using univariate statistical analysis.
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Intervention code [1]
327542
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Not applicable
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Comparator / control treatment
A comparison is being made between the “Younger” group (aged less than 70 years) and the “Older” group (aged 70 years or older). The comparator is the “Older” group (aged 70 years or older) diagnosed with DO-DU.
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Control group
Active
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Outcomes
Primary outcome [1]
336755
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Clinical presentation
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Assessment method [1]
336755
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Assessed by lower urinary tract symptoms, including voiding and storage symptoms from electronic medical records.
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Timepoint [1]
336755
0
at single timepoint of data collection
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Secondary outcome [1]
429599
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Risk factor to cause DO-DU
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Assessment method [1]
429599
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All measures will be assessed as a composite secondary outcome. Demographic information and past medical history components include diabetes mellitus, stroke, multiple sclerosis, spinal disease, Parkinson’s disease, neurogenic disorders, prior pelvic surgeries, prior incontinence surgery, and a history of pelvic radiation. Data were collected from medical records.
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Timepoint [1]
429599
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At single timepoint of data collection
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Secondary outcome [2]
430034
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Urodynamics finding
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Assessment method [2]
430034
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Data were collected from medical records. All the following urodynamic parameter measures will be assessed as a composite secondary outcome, including volume at first sensation of bladder filling, volume at normal desire to void, volume at strong desire to void, maximum cystometric capacity, bladder compliance, maximum flow rate during voiding (Qmax), detrusor pressure at the point of maximum flow (PdetQmax), voided volume (VV), postvoid residual urine (PVR), voiding efficiency (VE), calculated as the voided volume divided by the bladder capacity multiplied by 100, bladder contractility index (BCI), calculated as the PdetQmax plus five times Qmax, and presence of urodynamic abdominal straining during voiding.
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Timepoint [2]
430034
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At single timepoint of data collection
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Eligibility
Key inclusion criteria
1. Over the age of 18 years underwent urodynamic study between 2012 and 2022.
2. Patient diagnosed with DO-DU from urodynamic study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. A lack data for analysis.
2. Patients who have undergone intravesical botulinum toxin injections within the preceding 9 months.
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
The distribution of baseline characteristics, clinical symptoms, and urodynamic parameters were compared between patients under the age of 70 years and those greater than or equal to 70 years. Chi-square test was used for comparing proportions, and Wilcoxon rank sums were calculated for continuous and ordinal data. Statistics were conducted using STATA version 15.1, developed by StataCorp in College Station, TX, USA. P-value of 0.05 was used to denote statistical significance.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
16/11/2023
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Date of last participant enrolment
Anticipated
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Actual
30/11/2023
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Date of last data collection
Anticipated
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Actual
30/11/2023
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Sample size
Target
200
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Accrual to date
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Final
244
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
25908
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
41743
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
315351
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Hospital
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Name [1]
315351
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Austin health
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Address [1]
315351
0
145 Studley Road Heidelberg Victoria Australia, 3084
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Country [1]
315351
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Australia
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Primary sponsor type
University
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Name
Chiang Mai University
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Address
239, Huay Kaew Road, Muang District,Chiang Mai Thailand, 50200
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Country
Thailand
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Secondary sponsor category [1]
317410
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Hospital
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Name [1]
317410
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Austin health
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Address [1]
317410
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145 Studley Road Heidelberg Victoria Australia, 3084
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Country [1]
317410
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314270
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
314270
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145 Studley Road PO Box 5555 Heidelberg Victoria Australia 3084
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Ethics committee country [1]
314270
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Australia
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Date submitted for ethics approval [1]
314270
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02/11/2023
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Approval date [1]
314270
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16/11/2023
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Ethics approval number [1]
314270
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HREC/103156/Austin-2023
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Summary
Brief summary
Detrusor overactivity with detrusor underactivity (DO-DU) is classically described in frail institutionalized elderly patients, but we have also observed this diagnosis in younger populations. This research attempts to retrospectively compare demographic characteristics, clinical presentations, and urodynamic findings between two age groups of DO-DU patients: those younger than 70 years and those aged 70 years or older. Our hypothesis predicts that the younger group would exhibit a higher prevalence of risk factors in their demographic data, while the elderly group will demonstrate a greater incidence of urgency and urge incontinence, likely attributed to limited mobility. Additionally, the urodynamic findings are expected to reveal less bladder contraction in the elderly group, which can be attributed to the effects of advanced age.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
131002
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Dr Jaraspong Vuthiwong
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Address
131002
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Austin health, 145 Studley Road HEIDELBERG VIC 3084
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Country
131002
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Australia
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Phone
131002
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+61 0480452162
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Fax
131002
0
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Email
131002
0
[email protected]
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Contact person for public queries
Name
131003
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Dr Jaraspong Vuthiwong
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Address
131003
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Austin health, 145 Studley Road HEIDELBERG VIC 3084
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Country
131003
0
Australia
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Phone
131003
0
+61 0480452162
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Fax
131003
0
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Email
131003
0
[email protected]
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Contact person for scientific queries
Name
131004
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Dr Jaraspong Vuthiwong
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Address
131004
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Austin health, 145 Studley Road HEIDELBERG VIC 3084
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Country
131004
0
Australia
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Phone
131004
0
+61 0480452162
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Fax
131004
0
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Email
131004
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
21115
Study protocol
386986-(Uploaded-04-12-2023-09-55-18)-Study-related document.docx
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF