Pelvic Floor Contraction in Different Positions Among Women With and Without Stress Urinary Incontinence
1 other identifier
observational
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2020
CompletedFirst Posted
Study publicly available on registry
February 28, 2020
CompletedStudy Start
First participant enrolled
May 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedNovember 15, 2021
November 1, 2021
1.5 years
February 26, 2020
November 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
direction of urinary bladder displacement during contraction
upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound
baseline
Secondary Outcomes (3)
urinary bladder displacement in millimeters
baseline
pelvic floor muscles endurance of contraction in seconds
baseline
questioned about the degree of difficulty contracting the pelvic floor.
baseline
Study Arms (2)
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.
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.
Interventions
ultrasound examination of pelvic floor muscle will be conducted. In addition questionnaires regarding demographic characteristics and SUI will be performed.
Eligibility Criteria
Women, between ages 18-45 with and without USI.
You may qualify if:
- willing to participate in the study
- being able to squat for over 10 seconds.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Haifa University, Department of PHysical Therapy
Haifa, 31905, Israel
Related Publications (1)
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.
PMID: 16942457RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gali Dar, PhD
Gali Dar, Department of Physical Therapy, University of Haifa
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
February 26, 2020
First Posted
February 28, 2020
Study Start
May 17, 2020
Primary Completion
November 1, 2021
Study Completion
November 1, 2021
Last Updated
November 15, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 6 months following end of study
following study completion, a paper will be submitted to international professional journal