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

This study has been completed.
Sponsor:
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT01391780
First received: July 8, 2011
Last updated: July 27, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition
Urinary Incontinence, Stress
Urge Incontinence

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pelvic Floor Muscle Evaluation in Women With Stress Urinary and Urgency Urinary Incontinence. A Prospective Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Enrollment: 51
Study Start Date: March 1997
Study Completion Date: December 1998
Groups/Cohorts
Group 1
Patients with stress urinary incontinence
Group 2
Patients with urgency urinary incontinence.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • presence of stress urinary or urgency incontinence

Exclusion Criteria:

  • neurological diseases
  • previous pelvic surgeries
  • diabetes
  • cognitive difficulties
  • vaginal and urinary infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01391780

Locations
Brazil
São Paulo State University - Medical School of Botucatu
Botucatu, São Paulo, Brazil, 18618-970
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Investigators
Principal Investigator: João L. Amaro, PhD, MD Sao Paulo State University - UNESP
  More Information

No publications provided

Responsible Party: Prof. Trajano Sardenberg, Ethical Research Committee
ClinicalTrials.gov Identifier: NCT01391780     History of Changes
Other Study ID Numbers: 2011
Study First Received: July 8, 2011
Last Updated: July 27, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by UPECLIN HC FM Botucatu Unesp:
pelvic floor evaluation,
women,
stress urinary incontinence;
urgency urinary incontinence.

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urinary Incontinence, Urge
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013