Pilot Study for the Urinary Incontinence Treatment

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Device: Magic Kegel app

• Registration Number: NCT03042351
• Lead Sponsor: Instituto Palacios

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

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-09
• Study First Submitted: 2016-10-04
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-01
• Last Update Submitted: 2017-02-01
• Study First Posted: 2017-02-03
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• Urinary incontinence diagnosis

Exclusion Criteria

• No urinary infection
• No surgery for urinary incontinence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Unique arm	Magic Kegel app	Magic Kegel app

Primary Outcome Measures

Name	Time	Method
Changes in values registered in Magic Kegel App	Six months

Secondary Outcome Measures

Name	Time	Method
Changes in Sandvick questionnaire at month 2 respect to baseline	60 days
Changes in ICIQ-SF 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

Trial Locations

Locations (1)

Instituto Palacios; 🇪🇸 Madrid, Spain