NCT04114019

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

October 1, 2019

Last Update Submit

July 24, 2020

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Vaginal Elasticity

    Changes in vaginal elasticity post physiotherapy

    From the treatment cessation up to 6 months post-treatment

Secondary Outcomes (1)

  • Stress urinary incontinence

    From the treatment cessation up to 6 months post-treatment

Study Arms (1)

Stress urinary incontinence

Women suffering from stress urinary incontinence

Diagnostic Test: Vaginal tactile imager

Interventions

Vaginal tactile imagerDIAGNOSTIC_TEST

Vaginal elasticity evaluation using a vaginal tactile imager

Stress urinary incontinence

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • women suffering from stress urinary incontinence.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Roy Lauterbach, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2019

First Posted

October 3, 2019

Study Start

July 1, 2020

Primary Completion

December 30, 2020

Study Completion

April 1, 2021

Last Updated

July 27, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share