Pelvic Floor Displacement in Women With SUI and Healthy Women: An Ultrasound Study (Stress Urinary Incontinence) (SUI)

January 12, 2018 updated by: Iris sinai, Assuta Hospital Systems

The Influence of Various Breathing Protocols and Cough on the Amount of Pelvic Floor Displacement in Women With Stress Urinary Incontinence and Healthy Women: An Ultrasound Study

Pelvic floor main role is to maintain continence. pelvic floor malfunction could lead to urinary incontinence (UI). The known prevalence of UI among women is 25%-72%, in about 25%-50% it is Stress Urinary Incontinence (SUI), SUI prevalence changes with age and obstetric history. SUI is the complaint of involuntary leakage on activities which involves inter abdominal pressure rase, such as effort or exertion, or sneezing or coughing. pelvic floor movement is coordinated with the diaphragm, it moves caudally while inhaling and cranially while exhaling. it was shown that cranial sagittal displacement of the pelvic floor is correlated to pelvic floor normal and efficient function. in order to maintain continence while internal abdominal pressure rises the pelvic floor as to work in a precise trajectory, timing and force. observing the Urinary bladder by trans abdominal ultra sound (TAUS) was found as a valid and reliable way to estimate pelvic floor sagittal displacement and function.

Study Overview

Status

Unknown

Conditions

Detailed Description

50 women between the age 25-50 with a history of one vaginal delivery will be recruited for the study. 25 women who complain about stress urinary incontinence (research group) and 25 healthy women (control group). all research participants will sign first a participant consent form. all participants will be interviewed about their own delivery, measured for weight and height and follow a trans abdominal ultra sound (TAUS) examination. the research group participants will be asked to fill a quality of life questionaire concerning their SUI complaint.

at the TAUS examination the participant will be asked to perform:

  1. 3 times quiet breathing.
  2. 3 times forced exhalation.
  3. 3 times cough. while doing so an ultra sound image of the urinary bladder will be saved for displacement measurements.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Vered Eisenberg, Md

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Macabi hadar yossef

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

25 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

50 parous women, who performed one vaginal delivey. age 25-50. all women are 'macabi medical services' members. 25 women who complain about stress urinary incontinence. 25 healthy women.

Description

Inclusion Criteria:

  • women after one vaginal delivery on term.
  • women aged 25-50
  • members of 'macabi medical services'

Exclusion Criteria:

  • pregnancy
  • nulliparous women
  • women who had C section delivery
  • known neurologic disease
  • previous history of pelvic or back surgery
  • previous history of pelvic fracture
  • known pulmonary disease
  • active urinary tract 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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pelvic floor displacement
Time Frame: 20-30 minutes
in mm
20-30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incontinence Quality of Life (I-QOL)
Time Frame: 5 minutes
score of questionaire
5 minutes

Collaborators and Investigators

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

Sponsor

Assuta Hospital Systems

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

October 1, 2016

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

October 10, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 12, 2016

Study Record Updates

Last Update Posted (Actual)

January 16, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssutaHS0087-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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