Trial Review

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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
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
Secondary ID [1] 311092 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
detrusor overactivity with detrusor underactivity 332245 0
Condition category
Condition code
Surgery 328960 328960 0 0
Other surgery
Renal and Urogenital 329073 329073 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 327542 0
Not applicable
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.
Control group
Active

Outcomes
Primary outcome [1] 336755 0
Clinical presentation
Timepoint [1] 336755 0
at single timepoint of data collection
Secondary outcome [1] 429599 0
Risk factor to cause DO-DU
Timepoint [1] 429599 0
At single timepoint of data collection
Secondary outcome [2] 430034 0
Urodynamics finding
Timepoint [2] 430034 0
At single timepoint of data collection

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A lack data for analysis.
2. Patients who have undergone intravesical botulinum toxin injections within the preceding 9 months.

Study design
Purpose
Duration
Selection
Timing
Retrospective
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/11/2023
Date of last participant enrolment
Anticipated
Actual
30/11/2023
Date of last data collection
Anticipated
Actual
30/11/2023
Sample size
Target
200
Accrual to date
Final
244
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25908 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 41743 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 315351 0
Hospital
Name [1] 315351 0
Austin health
Country [1] 315351 0
Australia
Primary sponsor type
University
Name
Chiang Mai University
Address
239, Huay Kaew Road, Muang District,Chiang Mai Thailand, 50200
Country
Thailand
Secondary sponsor category [1] 317410 0
Hospital
Name [1] 317410 0
Austin health
Address [1] 317410 0
145 Studley Road Heidelberg Victoria Australia, 3084
Country [1] 317410 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314270 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 314270 0
145 Studley Road PO Box 5555 Heidelberg Victoria Australia 3084
Ethics committee country [1] 314270 0
Australia
Date submitted for ethics approval [1] 314270 0
02/11/2023
Approval date [1] 314270 0
16/11/2023
Ethics approval number [1] 314270 0
HREC/103156/Austin-2023

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131002 0
Dr Jaraspong Vuthiwong
Address 131002 0
Austin health, 145 Studley Road HEIDELBERG VIC 3084
Country 131002 0
Australia
Phone 131002 0
+61 0480452162
Fax 131002 0
Email 131002 0
Jaraspong.Vuthiwong@gmail.com
Contact person for public queries
Name 131003 0
Dr Jaraspong Vuthiwong
Address 131003 0
Austin health, 145 Studley Road HEIDELBERG VIC 3084
Country 131003 0
Australia
Phone 131003 0
+61 0480452162
Fax 131003 0
Email 131003 0
Jaraspong.Vuthiwong@gmail.com
Contact person for scientific queries
Name 131004 0
Dr Jaraspong Vuthiwong
Address 131004 0
Austin health, 145 Studley Road HEIDELBERG VIC 3084
Country 131004 0
Australia
Phone 131004 0
+61 0480452162
Fax 131004 0
Email 131004 0
Jaraspong.Vuthiwong@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21115Study 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.