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Pilot Study for the Urinary Incontinence Treatment

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Magic Kegel app
Sponsored by
Instituto Palacios
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary Incontinence, Pelvic Floor

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Urinary incontinence diagnosis

Exclusion Criteria:

  • No urinary infection
  • No surgery for urinary incontinence

Sites / Locations

  • Instituto Palacios

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Unique arm

Arm Description

Magic Kegel app

Outcomes

Primary Outcome Measures

Changes in values registered in Magic Kegel App

Secondary Outcome Measures

Changes in ICIQ-SF questionnaire at month 2 respect to baseline
Changes in FSFI questionnaire at month 2 respect to baseline
Changes in Sandvick questionnaire at month 2 respect to baseline
Changes in PISQ-12 questionnaire at month 2 respect to baseline

Full Information

First Posted
October 4, 2016
Last Updated
February 1, 2017
Sponsor
Instituto Palacios
Collaborators
eCareYou Innovation
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1. Study Identification

Unique Protocol Identification Number
NCT03042351
Brief Title
Pilot Study for the Urinary Incontinence Treatment
Official Title
Pilot Study for the Urinary Incontinence Treatment by Using a Pelvic Floor Muscles Restorative Device (E-NNA®)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Palacios
Collaborators
eCareYou Innovation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Urinary Incontinence, Pelvic Floor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unique arm
Arm Type
Other
Arm Description
Magic Kegel app
Intervention Type
Device
Intervention Name(s)
Magic Kegel app
Intervention Description
Pelvic floor muscles recover exercises with a specific device and Magic Kegel App
Primary Outcome Measure Information:
Title
Changes in values registered in Magic Kegel App
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Changes in ICIQ-SF questionnaire at month 2 respect to baseline
Time Frame
60 days
Title
Changes in FSFI questionnaire at month 2 respect to baseline
Time Frame
60 days
Title
Changes in Sandvick questionnaire at month 2 respect to baseline
Time Frame
60 days
Title
Changes in PISQ-12 questionnaire at month 2 respect to baseline
Time Frame
60 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Urinary incontinence diagnosis Exclusion Criteria: No urinary infection No surgery for urinary incontinence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santiago Palacios, MD
Organizational Affiliation
Instituto Palacios
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Palacios
City
Madrid
ZIP/Postal Code
28009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pilot Study for the Urinary Incontinence Treatment

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