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Measurement of Vaginal Squeeze Pressure in Incontinent Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00490438
First Posted: June 22, 2007
Last Update Posted: June 22, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital de Clinicas de Porto Alegre
  Purpose
The patients will be submited to a vaginal squeeze pressure measurements before and after surgeries for urinary incontinence.

Condition
Urinary Incontinence

Study Type: Observational
Study Design: Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Study Start Date: January 2007
Estimated Study Completion Date: July 2007
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.

  Eligibility

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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
Information from the National Library of Medicine

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 Submitted: June 20, 2007
First Posted: June 22, 2007
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