Healthy Clinical Trial - Pelvic Floor Displacement in Women With SUI &

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02930720
Study type	Observational
Source	Assuta Hospital Systems
Contact	Iris Sinai, Bpt
Phone	972-54-4468327
Email	Irisinai31@gmail.com
Status	Recruiting
Phase	N/A
Start date	October 2016
Completion date	October 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms