ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

nil

Universal Trial Number (UTN)

U1111-1119-2268

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

urinary incontinence

Condition category

Condition code

Renal and Urogenital

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]

Not applicable

Comparator / control treatment

NIL

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Prevalence of urinary incontinence in nulligravid women aged 16 to 30 years as assessed by the Questionnaire for Urinary Incontinence Diagnosis.

Timepoint [1]

This is assessed in each participant on a single occasion by way of completion of a questionnaire.

Secondary outcome [1]

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]

This is assessed in each participant on a single occasion by way of completion of a questionnaire.

Secondary outcome [2]

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]

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]

Self funded/Unfunded

Name [1]

NIL

Address [1]

NIL

Country [1]

Primary sponsor type

University

Name

Monash university

Address

Wellington Rd Clayton 3168 Victoria

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human research Ethics Committee

Ethics committee address [1]

Wellington Rd Clayton Vic 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

20/01/2011

Ethics approval number [1]

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

Prof Susan Davis

Address

Women's Health Research Program
Monash University
Level 6/ 99 Commercial Rd
Melbourne Vic 3004

Country

Australia

Phone

+61399030827

Fax

susan.davis@monash.edu

Contact person for public queries

Name

Susan Davis

Address

Women's Health Research Program
Monash University
Level 6/ 99 Commercial Rd
Melbourne Vic 3004

Country

Australia

Phone

+61399030827

Fax

susan.davis@monash.edu

Contact person for scientific queries

Name

Susan Davis

Address

Women's Health Research Program
Monash University
Level 6/ 99 Commercial Rd
Melbourne Vic 3004

Country

Australia

Phone

+61399030827

Fax

susan.davis@monash.edu

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

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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