Urinary IncontinenceNCT00765622
Assessment of Pelvic Floor Function in Elderly
An observational study of Urinary Incontinence, run by Catholic University of Brasília at 1 site in Brazil.
Trial summary
The purpose of this study is to demonstrate the importance of functional assessment of the pelvic floor (AFA) in older women, as prognostic factor for Urinary Incontinence (UI). Read more about this study
- Who is it for?
- Ages 58 to 87 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- How many people
- 153 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2007to Nov 2007
- Phase
- Observational
- 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 58 to 87 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: elderly women
Who may be able to join
- Elderly women
- Urinary incontinence
Who cannot join
- Cesarean surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Pelvic Floor Function in Women With Urinary Incontinence
The purpose of this study is to demonstrate the importance of functional assessment of the pelvic floor (AFA) in older women, as prognostic factor for Urinary Incontinence (UI).
Read the detailed description
Incontinence elderly assessment
- Conditions
- Urinary Incontinence
- Keywords
- Urinary incontinence, pelvic floor, functional evaluation
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| G2 | G2 = control group (no incontinence) | |
| G1 | G1 = urinary incontinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
All patients were submitted for review physiotherapeutic through palpation bidigital and quantification of contraction pelvic, was performed using a my feedback of pressure
Measured: Only one measure at the begging of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startApr 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of Brasília
- Sponsor type
- University, hospital or other
- Investigators
- Claudia EC Souza, Ms, Principal investigator, Catholic University of brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765622
- Sponsor's protocol ID
- ucb123cestari
- Status last verified
- Aug 2008
- First submitted
- 2 Oct 2008
- Last updated
- 3 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pelvic Floor Function in Women With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT00765622
- Acronym / sponsor ID
- ucb123cestari
- Conditions
- Urinary Incontinence
- Keywords
- Urinary incontinence, pelvic floor, functional evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Catholic University of BrasíliaUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 3 Oct 2008 (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.
The purpose of this study is to demonstrate the importance of functional assessment of the pelvic floor (AFA) in older women, as prognostic factor for Urinary Incontinence (UI).
Detailed description
Incontinence elderly assessment
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G2 | – | –G2 = control group (no incontinence) |
| G1 | – | –G1 = urinary incontinence |
Who may qualify
- Ages
- 58 to 87 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- elderly women
Key inclusion criteria (2 listed)
- Elderly women
- Urinary incontinence
Key exclusion criteria (1 listed)
- Cesarean surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All patients were submitted for review physiotherapeutic through palpation bidigital and quantification of contraction pelvic, was performed using a my feedback of pressure
Time frame: Only one measure at the begging of the study
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 3 Oct 2008.
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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.
Claudia EC Souza, Ms principal investigator
Catholic University of brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by Catholic University of Brasília at 1 site in Brazil.
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 2 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 3 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
All patients were submitted for review physiotherapeutic through palpation bidigital and quantification of contraction pelvic, was performed using a my feedback of pressure (time frame: Only one measure at the begging of the study). 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 3 Oct 2008.