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Completed

NCT Number: NCT04288648

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Haifa University, Department of PHysical Therapy

Haifa, 31905, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound examination

Diagnostic Test

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

Primary outcomes

  1. direction of urinary bladder displacement during contraction

    Time frame: baseline

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

Secondary outcomes

  1. urinary bladder displacement in millimeters

    Time frame: baseline

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

  2. pelvic floor muscles endurance of contraction in seconds

    Time frame: baseline

    time of muscle contraction will be measured during the last contraction

  3. questioned about the degree of difficulty contracting the pelvic floor.

    Time frame: baseline

    Each participant will grade on a scale of 1-10 (10 most difficult) the subjective difficulty of contraction in each position

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 28, 2020
Registry last updated
Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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