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Measurement of Vaginal Squeeze Pressure in Incontinent Patients

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ClinicalTrials.gov Identifier: NCT00490438
Recruitment Status : Unknown
Verified September 2006 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : June 22, 2007
Last Update Posted : June 22, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
The patients will be submited to a vaginal squeeze pressure measurements before and after surgeries for urinary incontinence.

Condition or disease
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

Study Type : Observational
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Study Start Date : January 2007
Estimated Study Completion Date : July 2007

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Groups and Cohorts


Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490438


Locations
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-903
Contact: José G Lopes Ramos, Dr    55 51 21018129    ramosjg@terra.com.br   
Principal Investigator: José G Lopes Ramos, Dr         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: José G Lopes ramos, Dr Hospital de Clnicas de Porto Alegre
More Information

ClinicalTrials.gov Identifier: NCT00490438     History of Changes
Other Study ID Numbers: 06-123
First Posted: June 22, 2007    Key Record Dates
Last Update Posted: June 22, 2007
Last Verified: September 2006

Keywords provided by Hospital de Clinicas de Porto Alegre:
perineometry
Modified Oxford Score
pelvic muscles evaluation
urinary incontinence
vaginal palpation

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders