Clinical trial NCT04288648: Pelvic Floor Contraction in Different Positions Among Women With and Without Stress Urinary Incontinence
Official title: Pelvic Floor Contraction in Different Positions Among Women With and Without Stress Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Stress Incontinence
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women, between ages 18-45 with and without USI.

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.

Eligibility criteria: 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

Primary outcomes:
measure: direction of urinary bladder displacement during contraction
timeFrame: baseline
Secondary outcomes:
measure: urinary bladder displacement in millimeters
timeFrame: baseline
measure: pelvic floor muscles endurance of contraction in seconds
timeFrame: baseline
measure: questioned about the degree of difficulty contracting the pelvic floor.
timeFrame: baseline
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Haifa University, Department of PHysical Therapy
Study officials:
affiliation: Gali Dar, Department of Physical Therapy, University of Haifa
name: Gali Dar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.