Pelvic Floor Contraction in Different Positions Among Women With and Without Stress Urinary Incontinence

Completed

• Conditions: Urinary Stress Incontinence
• Interventions: Diagnostic Test: ultrasound examination

• Registration Number: NCT04288648
• Lead Sponsor: University of Haifa

Brief Summary

Examination of pelvic floor contraction in different positions among women with and without stress urinary incontinence (SUI) will be conducted via diagnostic ultrasound. This will enable clinicians and researchers to establish an appropriate protocol for pelvic floor muscle examination and treatment.

Detailed Description

The main goal of this study is to compare the ability of the pelvic floor muscles to contract in different positions among women suffering from SUI to healthy women. Secondary objectives: is to compare subjective reports of the difficulty to contract the pelvic floor muscles between the two groups, and to examine the connection between the severity of urinary leakage and the ability to contract pelvic floor muscles.

The study will include 50 female participants in the ages of 18-45. Research group will include 25 participants suffering from SUI in accordance with the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and 25 healthy participants (grade 0 on the ICIQ-SF questionnaire).

The examination will be performed with an abdominal ultrasound device in supine, sitting, standing and squatting. The Height of the bladder base will be measured during rest period and maximal contraction. The extent and direction of bladder base movement would indicate the quality of pelvic floor performance. Next, the length of contraction time will be measured. The participant would hold the maximal contraction as long as possible in order to examine muscular endurance. Rest will be given between tests. After finishing the tests in all four postures, the participants will be questioned about the degree of difficulty contracting the pelvic floor.

Significance of the study: The importance of the research is about granting the clinicians and researchers additional tools in order to help establishing a protocol for pelvic floor muscle activity examination and treatment.

Study Timeline

• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-28
• Study Start: 2020-05-17
• Status Verified: 2021-11
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

• Other types of urinary leakage
• receiving pelvic floor treatments in the past or present
• active urinary or vaginal infections
• neurological diseases
• urologic, gynecologic or abdominal surgery
• pelvic organ prolapse
• pregnancy
• chronic cough
• constipation
• unbalanced diabetes and the use of medication that affects urination

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SUI group	ultrasound examination	Examination will include an abdominal ultrasound assessment of pelvic floor muscle in supine, sitting, standing and squatting. The Height of the bladder base will be measured during rest period and maximal contraction.
control group	ultrasound examination	Examination will include an abdominal ultrasound assessment of pelvic floor muscle in supine, sitting, standing and squatting. The Height of the bladder base will be measured during rest period and maximal contraction.

Primary Outcome Measures

Name	Time	Method
direction of urinary bladder displacement during contraction	baseline	upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound

Secondary Outcome Measures

Name	Time	Method
urinary bladder displacement in millimeters	baseline	bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
pelvic floor muscles endurance of contraction in seconds	baseline	time of muscle contraction will be measured during the last contraction
questioned about the degree of difficulty contracting the pelvic floor.	baseline	Each participant will grade on a scale of 1-10 (10 most difficult) the subjective difficulty of contraction in each position

Trial Locations

Locations (1)

Haifa University, Department of PHysical Therapy; 🇮🇱 Haifa, Israel