- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00490438
Measurement of Vaginal Squeeze Pressure in Incontinent Patients
Study Overview
Status
Conditions
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 Type
Contacts and Locations
Study Locations
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RS
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Porto Alegre, RS, Brazil, 90035-903
- Recruiting
- Hospital de Clinicas de Porto Alegre
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Contact:
- José G Lopes Ramos, Dr
- Phone Number: 55 51 21018129
- Email: ramosjg@terra.com.br
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Principal Investigator:
- José G Lopes Ramos, Dr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Stress, urge or mixed stress and urge urinary incontinence.
- Understanding and signing a letter of informed consent
Exclusion Criteria:
- Urinary tract infection.
- Genitourinary surgery during the previous six months.
- Pregnancy or in puerperal period.
- BMI > 40
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: José G Lopes ramos, Dr, Hospital de Clnicas de Porto Alegre
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-123
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