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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04288648
Enrollment
42
Registered
2020-02-28
Start date
2020-05-17
Completion date
2021-11-01
Last updated
2021-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Stress Incontinence

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.

Interventions

DIAGNOSTIC_TESTultrasound examination

ultrasound examination of pelvic floor muscle will be conducted. In addition questionnaires regarding demographic characteristics and SUI will be performed.

Sponsors

University of Haifa
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
direction of urinary bladder displacement during contractionbaselineupward or downward displacement of urinary bladder will be measured via diagnostic ultrasound

Secondary

MeasureTime frameDescription
urinary bladder displacement in millimetersbaselinebladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
pelvic floor muscles endurance of contraction in secondsbaselinetime of muscle contraction will be measured during the last contraction
questioned about the degree of difficulty contracting the pelvic floor.baselineEach participant will grade on a scale of 1-10 (10 most difficult) the subjective difficulty of contraction in each position

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026