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Pilot Study for the Urinary Incontinence Treatment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03042351
Enrollment
36
Registered
2017-02-03
Start date
2016-03-31
Completion date
2016-09-30
Last updated
2017-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Keywords

Urinary Incontinence, Pelvic Floor

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

Interventions

DEVICEMagic Kegel app

Pelvic floor muscles recover exercises with a specific device and Magic Kegel App

Sponsors

eCareYou Innovation
CollaboratorUNKNOWN
Instituto Palacios
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Urinary incontinence diagnosis

Exclusion criteria

* No urinary infection * No surgery for urinary incontinence

Design outcomes

Primary

MeasureTime frame
Changes in values registered in Magic Kegel AppSix months

Secondary

MeasureTime frame
Changes in ICIQ-SF questionnaire at month 2 respect to baseline60 days
Changes in FSFI questionnaire at month 2 respect to baseline60 days
Changes in Sandvick questionnaire at month 2 respect to baseline60 days
Changes in PISQ-12 questionnaire at month 2 respect to baseline60 days

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026