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

Sponsor
University of Haifa (Other)
Overall Status
Completed
CT.gov ID
NCT04288648
Collaborator
(none)
42
1
17.5
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
42 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Pelvic Floor Contraction in Different Positions Among Women With and Without Stress Urinary Incontinence
Actual Study Start Date :
May 17, 2020
Actual Primary Completion Date :
Nov 1, 2021
Actual Study Completion Date :
Nov 1, 2021

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. direction of urinary bladder displacement during contraction [baseline]

      upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound

    Secondary Outcome Measures

    1. urinary bladder displacement in millimeters [baseline]

      bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

    2. pelvic floor muscles endurance of contraction in seconds [baseline]

      time of muscle contraction will be measured during the last contraction

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Haifa University, Department of PHysical Therapy Haifa Israel 31905

    Sponsors and Collaborators

    • University of Haifa

    Investigators

    • Principal Investigator: Gali Dar, PhD, Gali Dar, Department of Physical Therapy, University of Haifa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gali Dar, principal investigator, University of Haifa
    ClinicalTrials.gov Identifier:
    NCT04288648
    Other Study ID Numbers:
    • HU 26/2020
    First Posted:
    Feb 28, 2020
    Last Update Posted:
    Nov 15, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 15, 2021