The Effect of Pelvic Floor Physiotherapy on Vaginal Elasticity

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Diagnostic test: Vaginal tactile imager

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women between 18-70 years of age, suffering from stress urinary incontinence, referred to pelvic floor physiotherapy.

Description

Inclusion Criteria:

• women suffering from stress urinary incontinence.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stress urinary incontinence; Women suffering from stress urinary incontinence	Diagnostic test: Vaginal tactile imager; Vaginal elasticity evaluation using a vaginal tactile imager

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal Elasticity	Changes in vaginal elasticity post physiotherapy	From the treatment cessation up to 6 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress urinary incontinence	Improvement in the urogenital distress inventory questionnaire score (range 0-15)	From the treatment cessation up to 6 months post-treatment

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: 0327-19-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No