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Measurement of Vaginal Squeeze Pressure in Incontinent Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00490438
First received: June 20, 2007
Last updated: NA
Last verified: September 2006
History: No changes posted
  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: Additional Descriptors: Convenience Sample
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   30 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00490438     History of Changes
Other Study ID Numbers: 06-123
Study First Received: June 20, 2007
Last Updated: June 20, 2007
Health Authority: Brazil: National Committee of Ethics in Research

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
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013