Clinical Trials Directory

Trials / Completed

CompletedNCT04288648

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

Status
Completed
Phase
Study type
Observational
Enrollment
42 (actual)
Sponsor
University of Haifa · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

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

Timeline

Start date
2020-05-17
Primary completion
2021-11-01
Completion
2021-11-01
First posted
2020-02-28
Last updated
2021-11-15

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT04288648. Inclusion in this directory is not an endorsement.