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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01391780
First Posted: July 12, 2011
Last Update Posted: December 11, 2013
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:
UPECLIN HC FM Botucatu Unesp
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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
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): 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 Universidade Estadual Paulista Júlio de Mesquita Filho
  More Information

Responsible Party: Prof. Trajano Sardenberg, Ethical Research Committee
ClinicalTrials.gov Identifier: NCT01391780     History of Changes
Other Study ID Numbers: 2011
First Submitted: July 8, 2011
First Posted: July 12, 2011
Last Update Posted: December 11, 2013
Last Verified: March 2011

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

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Urge
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders