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

NCT02930720 | Unknown

• 1 other identifier: AssutaHS0087-16
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Stress Urinary Incontinence

Keywords

TAUS; breathing protocols and cough; pelvic floor displacement; women; SUI

Outcome Measures

Primary Outcomes (1)

• pelvic floor displacement

  in mm

  20-30 minutes

Secondary Outcomes (1)

• Incontinence Quality of Life (I-QOL)

  5 minutes

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assuta Hospital Systems: lead

Study Sites (1)

Macabi hadar yossef

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress; Cough

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Central Study Contacts

Iris Sinai, Bpt

CONTACT

972-54-4468327; Irisinai31@gmail.com

Vered Eisenberg, Md

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 12, 2016
• Study Start: October 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 16, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)