Does Patient Activity Level Affect 24-Hour Pad Test Resul... | NCT01749527

Studies
Does Patient Activity Level Affect 24-Hour Pad Test Results in Stress-Incontinent Women

NCT01749527

Sponsor

St George Hospital, Australia

Status

Completed

Last Update Posted

Dec 13, 2012Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

24-hour Pad Test Weight Gain With and Without Activity

Interventions

minimal activity

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Dec 11, 2012

First Submission Date that Met QC Criteria

Dec 12, 2012

First Posted Date

Dec 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2012

Last Update Posted Date

Dec 13, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We hypothesised that in women with stress urinary incontinence, the severity of leakage on a 24 hour pad test was affected by activity.

Detailed Description

We asked women to perform two separate pad tests, one with normal activity, and another with decreased activity.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
24-hour pad test	Other	decreased activity	Behavioral: minimal activity

Interventions

Name	Type	Description	Arm Group Labels	Other Names
minimal activity	Behavioral	Pad test with minimal activity	24-hour pad test

Measure	Description	Time Frame
24-hour pad test weight gain (mls)		24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stress urinary incontinence

Exclusion Criteria:

language other than english

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009043	Motor Activity
D014550	Urinary Incontinence, Stress

Ancestor Terms

ID	Term
D001519	Behavior
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided