Pelvic Floor Muscle Function Among Running Women

Urinary Stress Incontinence Clinical Trial

Official title:

Pelvic Floor Muscle Function Among Running Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05961241
• Other study ID #: 170/22
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2024
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

Other:
• runnin training program
gradual training program

Locations

Country	Name	City	State
Israel	Haifa University, Department of PHysical Therapy	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
University of Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	direction of urinary bladder displacement during contraction	upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound	baseline
Primary	urinary bladder displacement in millimeters	bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool	baseline
Primary	pelvic floor muscles endurance of contraction in seconds	time of muscle contraction will be measured during the last contraction	baseline
Primary	urinary incontinence	International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF).	baseline