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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Stress Incontinence
• Intervention / Treatment: Diagnostic test: ultrasound examination

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 Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31905
    • Haifa University, Department of PHysical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women, between ages 18-45 with and without USI.

Description

Inclusion Criteria (general):

• willing to participate in the study
• being able to squat for over 10 seconds.
• inclusion for study group - participants suffering from SUI that received a grade>0 in sections 3+4 (how frequent does urinary leakage appear, the amount of urine leakage and does the participant use pads for leakage absorption) and a grade>0 in section 5 (how much does SUI interrupt the participant's daily life) in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF).
• Inclusion for control group - healthy participants (grade 0 in the ICIQ- SF questionnaire).

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SUI group; 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.	Diagnostic test: ultrasound examination; ultrasound examination of pelvic floor muscle will be conducted. In addition questionnaires regarding demographic characteristics and SUI will be performed.; Other Names: transabdominal ultrasound assessment
control group; 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.	Diagnostic test: ultrasound examination; ultrasound examination of pelvic floor muscle will be conducted. In addition questionnaires regarding demographic characteristics and SUI will be performed.; Other Names: transabdominal ultrasound assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
direction of urinary bladder displacement during contraction	upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound	baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Haifa

Publications and helpful links

General Publications

• Sapsford RR, Richardson CA, Stanton WR. Sitting posture affects pelvic floor muscle activity in parous women: an observational study. Aust J Physiother. 2006;52(3):219-22. doi: 10.1016/s0004-9514(06)70031-9.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2020
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: HU 26/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: following study completion, a paper will be submitted to international professional journal
• IPD Sharing Time Frame: 6 months following end of study
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No