Pilot Study for the Urinary Incontinence Treatment

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042351
• Other study ID #: IP-ENNA-2015
• Status: Completed
• Phase: N/A
• First received: October 4, 2016
• Last updated: February 1, 2017
• Start date: March 2016
• Est. completion date: September 2016

Study information

• Verified date: February 2017
• Source: Instituto Palacios
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Urinary incontinence diagnosis

Exclusion Criteria:

• No urinary infection

• No surgery for urinary incontinence

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Device:
• Magic Kegel app
Pelvic floor muscles recover exercises with a specific device and Magic Kegel App

Locations

Country	Name	City	State
Spain	Instituto Palacios	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Palacios	eCareYou Innovation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in values registered in Magic Kegel App		Six months
Secondary	Changes in ICIQ-SF questionnaire at month 2 respect to baseline		60 days
Secondary	Changes in FSFI questionnaire at month 2 respect to baseline		60 days
Secondary	Changes in Sandvick questionnaire at month 2 respect to baseline		60 days
Secondary	Changes in PISQ-12 questionnaire at month 2 respect to baseline		60 days