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Clinical Trials/NCT03042351
NCT03042351
Completed
Not Applicable

Pilot Study for the Urinary Incontinence Treatment by Using a Pelvic Floor Muscles Restorative Device (E-NNA®)

Instituto Palacios1 site in 1 country36 target enrollmentMarch 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Incontinence
Sponsor
Instituto Palacios
Enrollment
36
Locations
1
Primary Endpoint
Changes in values registered in Magic Kegel App
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Non invasive study to improve the urinary incontinence, through pelvic floor muscles exercises

Detailed Description

A non invasive study to improve the urinary incontinence performed in 36 women from two groups: 18 menopausal women and 18 fertile women. The participants have to do pelvic floor muscles exercises with a restorative pelvic floor device every day for two months using the Magic Kegel app download in their mobile devices

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
September 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Urinary incontinence diagnosis

Exclusion Criteria

  • No urinary infection
  • No surgery for urinary incontinence

Outcomes

Primary Outcomes

Changes in values registered in Magic Kegel App

Time Frame: Six months

Secondary Outcomes

  • Changes in ICIQ-SF questionnaire at month 2 respect to baseline(60 days)
  • Changes in Sandvick questionnaire at month 2 respect to baseline(60 days)
  • Changes in FSFI questionnaire at month 2 respect to baseline(60 days)
  • Changes in PISQ-12 questionnaire at month 2 respect to baseline(60 days)

Study Sites (1)

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