Measurement of Vaginal Squeeze Pressure in Incontinent Patients

Urinary Incontinence Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00490438
• Other study ID #: 06-123
• Status: Recruiting
• Phase: N/A
• First received: June 20, 2007
• Last updated: June 20, 2007
• Start date: January 2007
• Est. completion date: July 2007

Study information

• Verified date: September 2006
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

The patients will be submited to a vaginal squeeze pressure measurements before and after surgeries for urinary incontinence.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Urinary Incontinence

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil,