Back to resultsPelvic Floor Muscle Function Among Running Women
Primary Purpose
Urinary Stress Incontinence
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
runnin training program
Sponsored by
About this trial
This is an interventional screening trial for Urinary Stress Incontinence focused on measuring Urinary incontinence, pelvic diaphragm, women's health
Eligibility Criteria
Inclusion Criteria: at least six months after giving birth or who have not given birth at all, The running group will recruit healthy women who run at least 3 times a week, 30 minutes, for two consecutive years. The control group will recruit healthy women who do not physical active on a daily basis Exclusion Criteria: pregnancy grade 3 or higher of pelvic organ prolapse.
Sites / Locations
- Haifa University, Department of PHysical TherapyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
running group
control
Arm Description
women who run on a regular basis
women who do not run
Outcomes
Primary Outcome Measures
direction of urinary bladder displacement during contraction
upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound
urinary bladder displacement in millimeters
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
pelvic floor muscles endurance of contraction in seconds
time of muscle contraction will be measured during the last contraction
urinary incontinence
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05961241
Brief Title
Pelvic Floor Muscle Function Among Running Women
Official Title
Pelvic Floor Muscle Function Among Running Women
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Haifa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will examine pelvic floor muscles function amongst women who run on a regular basis compared to controls. Women who do not run, will begin running protocol, and second evaluation will be performed following 2 months of training. Urinary incontinence will also be assessed.
Detailed Description
The study will include women who have been running on a regular basis over two years, at least 3 times a week for half an hour (research group) and women who do not run at all (control group). The participants will answer a personal information questionnaire (including birth and exercise background), and the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF). Outcome measures will include an evaluation of the PFM function using Vaginal palpation and abdominal ultrasound examination.
Women who do not run at all, will begin running training protocol, and second evaluation will be performed following 2 months of training.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stress Incontinence
Keywords
Urinary incontinence, pelvic diaphragm, women's health
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
running group
Arm Type
Active Comparator
Arm Description
women who run on a regular basis
Arm Title
control
Arm Type
Experimental
Arm Description
women who do not run
Intervention Type
Other
Intervention Name(s)
runnin training program
Other Intervention Name(s)
running
Intervention Description
gradual training program
Primary Outcome Measure Information:
Title
direction of urinary bladder displacement during contraction
Description
upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound
Time Frame
baseline
Title
urinary bladder displacement in millimeters
Description
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
Time Frame
baseline
Title
pelvic floor muscles endurance of contraction in seconds
Description
time of muscle contraction will be measured during the last contraction
Time Frame
baseline
Title
urinary incontinence
Description
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF).
Time Frame
baseline
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study examines pelvic floor function among women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
at least six months after giving birth or who have not given birth at all, The running group will recruit healthy women who run at least 3 times a week, 30 minutes, for two consecutive years.
The control group will recruit healthy women who do not physical active on a daily basis
Exclusion Criteria:
pregnancy
grade 3 or higher of pelvic organ prolapse.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gali Dar, Prof
Phone
972505662054
Email
galidar@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gali Dar, Prof.
Organizational Affiliation
University of Haifa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haifa University, Department of PHysical Therapy
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gali Dar, PhD
Phone
972-50-5662054
Email
galidar@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Pelvic Floor Muscle Function Among Running Women
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