24-hour Pad Test Weight Gain With and Without ActivityNCT01749527
Does Patient Activity Level Affect 24-Hour Pad Test Results in Stress-Incontinent Women
A study testing minimal activity in people with 24-hour Pad Test Weight Gain With and Without Activity, run by St George Hospital, Australia.
Trial summary
We hypothesised that in women with stress urinary incontinence, the severity of leakage on a 24 hour pad test was affected by activity. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- 24-hour Pad Test Weight Gain With and Without Activity
- What is being tested?
- minimal activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stress urinary incontinence
Who cannot join
- language other than english
About this study
Official title: Does Patient Activity Level Affect 24-Hour Pad Test Results in Stress-Incontinent Women?
We hypothesised that in women with stress urinary incontinence, the severity of leakage on a 24 hour pad test was affected by activity.
Read the detailed description
We asked women to perform two separate pad tests, one with normal activity, and another with decreased activity.
- Being tested
- minimal activity
- Keywords
- 24-hour pad test, Activity, Stress urinary incontinence
- Medical subject headings
- Motor Activity, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimal activityBehavioural
Pad test with minimal activity
| Study group | Role | What they receive |
|---|---|---|
| 24-hour pad test | Other | decreased activity Receives: Behavioral: minimal activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour pad test weight gain (mls)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startMar 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 24-hour Pad Test Weight Gain With and Without ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George Hospital, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmanuel Karantanis, St George Hospital, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749527
- Sponsor's protocol ID
- Activity Study
- Status last verified
- Dec 2012
- First submitted
- 11 Dec 2012
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Patient Activity Level Affect 24-Hour Pad Test Results in Stress-Incontinent Women?
- ClinicalTrials.gov ID
- NCT01749527
- Acronym / sponsor ID
- Activity Study
- Keywords
- 24-hour pad test, Activity, Stress urinary incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St George Hospital, AustraliaUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 24-hour pad test | Other | Behavioral: minimal activitydecreased activity |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stress urinary incontinence
Key exclusion criteria (1 listed)
- language other than english
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| minimal activityPad test with minimal activity | Behavioural | 24-hour pad test |
Primary outcome
24-hour pad test weight gain (mls)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing minimal activity in people with 24-hour Pad Test Weight Gain With and Without Activity, run by St George Hospital, Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour pad test weight gain (mls) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2012.