ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02930720
Recruitment Status : Recruiting
First Posted : October 12, 2016
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Iris sinai, Assuta Hospital Systems

Brief Summary:
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.

Condition or disease
Healthy Stress Urinary Incontinence

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
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: 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
Study Start Date : October 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. pelvic floor displacement [ Time Frame: 20-30 minutes ]
    in mm


Secondary Outcome Measures :
  1. Incontinence Quality of Life (I-QOL) [ Time Frame: 5 minutes ]
    score of questionaire



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

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): NCT02930720


Contacts
Contact: Iris Sinai, Bpt 972-54-4468327 Irisinai31@gmail.com
Contact: Vered Eisenberg, Md

Locations
Israel
Macabi hadar yossef Recruiting
Tel Aviv, Israel
Sponsors and Collaborators
Assuta Hospital Systems

Responsible Party: Iris sinai, Director, Assuta Hospital Systems
ClinicalTrials.gov Identifier: NCT02930720     History of Changes
Other Study ID Numbers: AssutaHS0087-16
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Iris sinai, Assuta Hospital Systems:
TAUS
breathing protocols and cough
pelvic floor displacement
women
SUI

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