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Clinical Trials/NCT04114019
NCT04114019WithdrawnNot Applicable

The Effect of Pelvic Floor Physiotherapy on Vaginal Elasticity as Measured by a Vaginal Tactile Imager

Rambam Health Care Campus0 sitesStarted: July 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Primary Endpoint
Vaginal Elasticity

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • women suffering from stress urinary incontinence.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Vaginal Elasticity

Time Frame: From the treatment cessation up to 6 months post-treatment

Changes in vaginal elasticity post physiotherapy

Secondary Outcomes

  • Stress urinary incontinence(From the treatment cessation up to 6 months post-treatment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

ROY LAUTERBACH MD

Principal Investigator

Rambam Health Care Campus

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