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

Healthy Clinical Trial

— SUI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02930720
• Other study ID #: AssutaHS0087-16
• Status: Recruiting
• Phase: N/A
• First received: October 10, 2016
• Last updated: January 12, 2018
• Start date: October 2016
• Est. completion date: October 2018

Study information

• Verified date: January 2018
• Source: Assuta Hospital Systems
• Contact: Iris Sinai, Bpt
• Phone: 972-54-4468327
• Email: Irisinai31[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Healthy
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Locations

Country	Name	City	State
Israel	Macabi hadar yossef	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Hospital Systems

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pelvic floor displacement	in mm	20-30 minutes
Secondary	Incontinence Quality of Life (I-QOL)	score of questionaire	5 minutes