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OpenTrials
Completed

NCT Number: NCT03042351

Pilot Study for the Urinary Incontinence Treatment

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

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Palacios

Madrid, 28009, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Urinary incontinence diagnosis

Exclusion criteria

  • No urinary infection
  • No surgery for urinary incontinence

Treatment and study plan

Magic Kegel app

Device

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

Primary outcomes

  1. Changes in values registered in Magic Kegel App

    Time frame: Six months

Secondary outcomes

  1. Changes in ICIQ-SF questionnaire at month 2 respect to baseline

    Time frame: 60 days

  2. Changes in FSFI questionnaire at month 2 respect to baseline

    Time frame: 60 days

  3. Changes in Sandvick questionnaire at month 2 respect to baseline

    Time frame: 60 days

  4. Changes in PISQ-12 questionnaire at month 2 respect to baseline

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

Instituto Palacios

Other

Collaborators

  • eCareYou Innovation

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 3, 2017
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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