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NCT04114019 Clinical Trial

The Effect of Pelvic Floor Physiotherapy on Vaginal Elasticity

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04114019
Other study ID # 0327-19-RMB
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date April 1, 2021

Study information
Verified date July 2020
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 1, 2021
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- women suffering from stress urinary incontinence.

Exclusion Criteria:

- women suffering from urge urinary incontinence.

- women suffering of mixed urinary incontinence.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Vaginal tactile imager
Vaginal elasticity evaluation using a vaginal tactile imager

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Outcome
Type Measure Description Time frame Safety issue
Primary Vaginal Elasticity Changes in vaginal elasticity post physiotherapy From the treatment cessation up to 6 months post-treatment
Secondary Stress urinary incontinence Improvement in the urogenital distress inventory questionnaire score (range 0-15) From the treatment cessation up to 6 months post-treatment
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