Pelvic Floor Muscle Evaluation in Women With Stress Urinary and Urgency Urinary Incontinence

December 10, 2013 updated by: UPECLIN HC FM Botucatu Unesp

Pelvic Floor Muscle Evaluation in Women With Stress Urinary and Urgency Urinary Incontinence. A Prospective Trial

Aims: To assess pelvic floor muscle (PFM) strength in women with stress urinary incontinence (SUI) and urgency urinary incontinence (UUI).

Methods: 51 women were prospectively divided into two groups, according to the symptoms as SUI (G1 = 22) or UUI (G2 = 29). Demographic data, such as number of Pads/ 24 hours, number of micturitions/ 24 hours and nocturia, delay time of urgent void (i.e., the time period for which an urgent void could be voluntarily postponed), number of parity and vaginal deliveries were obtained using a clinical questionnaire. Objective urine loss was evaluated by 60-min Pad Test. Subjective [urine stream interruption test (UST), visual survey of perineal contraction and transvaginal digital palpation] and objective (vaginal manometry) evaluations of PFM were performed in all patients.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-970
        • São Paulo State University - Medical School of Botucatu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The sample size was established considering a significance level of 5%, the test power of 80%, and the estimated error of 10%. According to these results and considering the range between percentages of answers as the casual error, each group was established with approximately 20 participants.

Description

Inclusion Criteria:

  • presence of stress urinary or urgency incontinence

Exclusion Criteria:

  • neurological diseases
  • previous pelvic surgeries
  • diabetes
  • cognitive difficulties
  • vaginal and urinary infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1
Patients with stress urinary incontinence
Group 2
Patients with urgency urinary incontinence.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: João L. Amaro, PhD, MD, Universidade Estadual Paulista Julio de Mesquita Filho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1997

Study Completion (Actual)

December 1, 1998

Study Registration Dates

First Submitted

July 8, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

March 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Incontinence, Stress

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