The Effect of Pelvic Floor Physiotherapy on Vaginal Elasticity

• ClinicalTrials.gov Identifier: NCT04114019
• Recruitment Status: Withdrawn
• First Posted: October 3, 2019
• Last Update Posted: July 27, 2020
• Sponsor: Rambam Health Care Campus
• Information provided by (Responsible Party): ROY LAUTERBACH MD, Rambam Health Care Campus

Tracking Information

• First Submitted Date: October 1, 2019
• First Posted Date: October 3, 2019
• Last Update Posted Date: July 27, 2020
• Estimated Study Start Date: July 1, 2020
• Estimated Primary Completion Date: December 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 1, 2019)

Vaginal Elasticity [ Time Frame: From the treatment cessation up to 6 months post-treatment ]

Changes in vaginal elasticity post physiotherapy

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 13, 2019)

Stress urinary incontinence [ Time Frame: From the treatment cessation up to 6 months post-treatment ]

Improvement in the urogenital distress inventory questionnaire score (range 0-15)

Original Secondary Outcome Measures (submitted: October 1, 2019)

Stress urinary incontinence [ Time Frame: From the treatment cessation up to 6 months post-treatment ]

Improvement in stress urinary incontinence symptoms on a numeric scale

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Pelvic Floor Physiotherapy on Vaginal Elasticity
• Official Title: The Effect of Pelvic Floor Physiotherapy on Vaginal Elasticity as Measured by a Vaginal Tactile Imager
• Brief Summary: Women suffering from stress urinary incontinence are offered pelvic floor physiotherapy as an optional treatment. Strengthening of the pelvic floor is measured to date by manual examination and lacks precise evaluation. The vaginal tactile imager assists in evaluation of the changes in the pelvic floor after physiotherapy.
• Detailed Description: Women with stress urinary incontinence will undergo 6-10 pelvic floor strengthening physiotherapy sessions. The participants will undergo a short examination of vaginal elasticity using a vaginal tactile imager prior to beginning physiotherapy and additional examinations after 6 treatments, 10 treatments and 3 and 6 months post-treatment cessation.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Women between 18-70 years of age, suffering from stress urinary incontinence, referred to pelvic floor physiotherapy.
• Condition: Stress Urinary Incontinence

Intervention

Diagnostic Test: Vaginal tactile imager

Vaginal elasticity evaluation using a vaginal tactile imager

Study Groups/Cohorts

Stress urinary incontinence

Women suffering from stress urinary incontinence

Intervention: Diagnostic Test: Vaginal tactile imager

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: July 24, 2020): 0
• Original Estimated Enrollment (submitted: October 1, 2019): 30
• Estimated Study Completion Date: April 1, 2021
• Estimated Primary Completion Date: December 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• women suffering from stress urinary incontinence.

Exclusion Criteria:

• women suffering from urge urinary incontinence.
• women suffering of mixed urinary incontinence.

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Female

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04114019
• Other Study ID Numbers: 0327-19-RMB
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: ROY LAUTERBACH MD, Rambam Health Care Campus
• Original Responsible Party: Same as current
• Current Study Sponsor: Rambam Health Care Campus
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Roy Lauterbach, MD; Rambam Health Care Campus

• PRS Account: Rambam Health Care Campus
• Verification Date: July 2020