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: December 10, 2013
Last verified: March 2011
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: December 10, 2013
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 July 22, 2014