Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000997651
Ethics application status
Approved
Date submitted
1/09/2014
Date registered
16/09/2014
Date last updated
18/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the prevalence of Urinary Incontinence in young women
Scientific title
Investigating the prevalence of Urinary Incontinence in young women
Secondary ID [1] 253479 0
nil
Universal Trial Number (UTN)
U1111-1119-2268
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urinary incontinence 261029 0
Condition category
Condition code
Renal and Urogenital 259169 259169 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
The prevalence of urinary incontinence (UI) in healthy nulliparous women aged 16 to 30 years is being investigated in the general community using a questionnaire survey. We will also look at risk factors and the impact on daily living, including physical activity and Psychological General Well Being. Questionnaires were administered for each participant on a single occasion.
Intervention code [1] 290152 0
Not applicable
Comparator / control treatment
NIL
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293077 0
Prevalence of urinary incontinence in nulligravid women aged 16 to 30 years as assessed by the Questionnaire for Urinary Incontinence Diagnosis.
Timepoint [1] 293077 0
This is assessed in each participant on a single occasion by way of completion of a questionnaire.
Secondary outcome [1] 310293 0
Potential risk factors pf urinary incontinence in nulliparous women aged between 16 and 30 years as assessed by the The King’s Health Questionnaire, The International Physical Activity Questionnaire-Short Form and The Psychological General Well Being Index.
Timepoint [1] 310293 0
This is assessed in each participant on a single occasion by way of completion of a questionnaire.
Secondary outcome [2] 310402 0
The impact of urinary incontinence on nulliparous women aged between 16 and 30 years on quality of life as assessed by the The King’s Health Questionnaire, The International Physical Activity Questionnaire-Short Form and The Psychological General Well Being Index.
Timepoint [2] 310402 0
This is assessed in each participant on a single occasion by way of completion of a questionnaire.

Eligibility
Key inclusion criteria
Aged 16- 30 years, nulligravid and willing to complete an English questionnaire
Minimum age
16 Years
Maximum age
30 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current urinary tract infection

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2011
Actual
1/03/2011
Date of last participant enrolment
Anticipated
8/07/2011
Actual
8/07/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
1002
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289889 0
Self funded/Unfunded
Name [1] 289889 0
NIL
Country [1] 289889 0
Primary sponsor type
University
Name
Monash university
Address
Wellington Rd Clayton 3168 Victoria
Country
Australia
Secondary sponsor category [1] 288569 0
None
Name [1] 288569 0
Address [1] 288569 0
Country [1] 288569 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291612 0
Monash University Human research Ethics Committee
Ethics committee address [1] 291612 0
Wellington Rd Clayton Vic 3168
Ethics committee country [1] 291612 0
Australia
Date submitted for ethics approval [1] 291612 0
Approval date [1] 291612 0
20/01/2011
Ethics approval number [1] 291612 0

Summary
Brief summary
Background Whilst pregnancy is a risk factor for urinary incontinence (UI), this condition may precede pregnancy. The prevalence of UI in nulligravid women has not been reported.
Objective To investigate the prevalence of UI in young nulligravid women, potential risk factors and the impact on quality of life.
Design Single centre, cross-sectional, self-administered questionnaire-based study.
Setting University clinical research department
Participants Nulligravid Australian women aged 16 to 30 years. Measurements The Questionnaire for Urinary Incontinence Diagnosis, the Psychological General Wellbeing Index (PGWB), the King’s Health Questionnaire and the International Physical Activity Questionnaire. Demographic variables and potential risk factors were also documented.
Results 1002 women, mean age 22.4 (SD 3.2) years, provided data. The rate of any UI was 12.6% (95% confidence interval (CI), 10.5-14.7%). The rate of stress-only UI was 6.2% (95% CI, 4.7-7.7%), urge-only UI 4.5% (95% CI, 3.2-5.8%) and mixed UI 1.9% (95% CI, 1.1-2.7%). In logistic regression analyses, ever being sexually active (OR 2.33, 95%CI 1.40 to 3.88) was associated with an increased likelihood of UI, whereas current use of the combined oral contraceptive (COC) was associated with a reduced likelihood of UI (OR 0.38 95% CI 0.24 to 0.61). Women with UI had significantly lower wellbeing than women without UI (mean difference in total PGWB score 5.3 (95% CI 2.3-8.3). Statistically significant lower scores were seen for the PGWB domains of for anxiety (P<0.001), depression (P<0.001), positive well-being (P=0.02) and self-control (P=0.001).
Limitations The findings relate to a relatively healthy and active cohort.
Conclusions UI was common in this sample of healthy, nulligravid young women and was significantly associated with lower general psychological wellbeing. Further study is required to understand the pathophysiology of UI in young women and management options.
Trial website
Trial related presentations / publications
Annals of Internal Medicine O'Halloran T et al, Urinary incontinence in young nulligravid women: a cross-sectional analysis. 2012;157:87-93
Public notes
Study Published in Annals of Internal Medicine O'Halloran T et al, Urinary incontinence in young nulligravid women: a cross-sectional analysis. 2012;157:87-93

Contacts
Principal investigator
Name 32133 0
Prof Susan Davis
Address 32133 0
Women's Health Research Program
Monash University
Level 6/ 99 Commercial Rd
Melbourne Vic 3004
Country 32133 0
Australia
Phone 32133 0
+61399030827
Fax 32133 0
Email 32133 0
[email protected]
Contact person for public queries
Name 15380 0
Susan Davis
Address 15380 0
Women's Health Research Program
Monash University
Level 6/ 99 Commercial Rd
Melbourne Vic 3004
Country 15380 0
Australia
Phone 15380 0
+61399030827
Fax 15380 0
Email 15380 0
[email protected]
Contact person for scientific queries
Name 6308 0
Susan Davis
Address 6308 0
Women's Health Research Program
Monash University
Level 6/ 99 Commercial Rd
Melbourne Vic 3004
Country 6308 0
Australia
Phone 6308 0
+61399030827
Fax 6308 0
Email 6308 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.