Urinary IncontinenceNCT00490438
Measurement of Vaginal Squeeze Pressure in Incontinent Patients
An observational study of Urinary Incontinence, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The patients will be submited to a vaginal squeeze pressure measurements before and after surgeries for urinary incontinence. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Urinary Incontinence
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Jan 2007to Jul 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 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stress, urge or mixed stress and urge urinary incontinence.
- Understanding and signing a letter of informed consent
Who cannot join
- Urinary tract infection.
- Genitourinary surgery during the previous six months.
- Pregnancy or in puerperal period.
- BMI > 40
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
José G Lopes Ramos, Dr, 55 51 21018129, ramosjg@terra.com.br
José G Lopes Ramos, Dr
About this study
The patients will be submited to a vaginal squeeze pressure measurements before and after surgeries for urinary incontinence.
Read the detailed description
Several techniques had been proposed for pelvic floor muscles assessment, however none of them were able to measure the two main functions of these muscles: rising and force of compression. Vaginal palpation is frequently used in clinical evaluation routine and especially the modified Oxford score, but some articles question the Oxford scale sensitivity and its correlation with objective force contraction measurements.
Methods: 45 patients with urinary incontinence treated at the Uroginecology Ambulatory Service of the Hospital de Clínicas de Porto Alegre were included. The patients had been submitted to vaginal palpation using the Oxford score, assessed by a skilled physical therapist, and to the compression force measurement by means of an air filled ballonet connected to a pressure transducer. The two evaluations had been carried in the same day.
- Conditions
- Urinary Incontinence
- Keywords
- perineometry, Modified Oxford Score, pelvic muscles evaluation, urinary incontinence, vaginal palpation
- Medical subject headings
- Urinary Incontinence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2007 (estimated)
- Study startJan 2007
- Study completionJul 2007 (estimated)
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.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- José G Lopes ramos, Dr, Principal investigator, Hospital de Clnicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490438
- Sponsor's protocol ID
- 06-123
- Status last verified
- Sep 2006
- First submitted
- 20 Jun 2007
- Last updated
- 22 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Vaginal Squeeze Pressure in Incontinent Patients
- ClinicalTrials.gov ID
- NCT00490438
- Acronym / sponsor ID
- 06-123
- Conditions
- Urinary Incontinence
- Keywords
- perineometry, Modified Oxford Score, pelvic muscles evaluation, urinary incontinence, vaginal palpation
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Jul 2007 (estimated)
- First posted
- 22 Jun 2007 (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 patients will be submited to a vaginal squeeze pressure measurements before and after surgeries for urinary incontinence.
Detailed description
Several techniques had been proposed for pelvic floor muscles assessment, however none of them were able to measure the two main functions of these muscles: rising and force of compression. Vaginal palpation is frequently used in clinical evaluation routine and especially the modified Oxford score, but some articles question the Oxford scale sensitivity and its correlation with objective force contraction measurements.
Methods: 45 patients with urinary incontinence treated at the Uroginecology Ambulatory Service of the Hospital de Clínicas de Porto Alegre were included. The patients had been submitted to vaginal palpation using the Oxford score, assessed by a skilled physical therapist, and to the compression force measurement by means of an air filled ballonet connected to a pressure transducer. The two evaluations had been carried in the same day.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stress, urge or mixed stress and urge urinary incontinence.
- Understanding and signing a letter of informed consent
Key exclusion criteria (4 listed)
- Urinary tract infection.
- Genitourinary surgery during the previous six months.
- Pregnancy or in puerperal period.
- BMI > 40
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2007.
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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.
José G Lopes ramos, Dr principal investigator
Hospital de Clnicas de Porto Alegre
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 Hospital de Clinicas de Porto Alegre 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 4 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: status not confirmed, as of the sponsor's last update on 22 Jun 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 22 Jun 2007.