Pilot Study for the Urinary Incontinence Treatment | NCT03042351

Studies
Pilot Study for the Urinary Incontinence Treatment

NCT03042351

Sponsor

Instituto Palacios

Status

Completed

Last Update Posted

Feb 3, 2017Estimated

Enrollment

36Actual

Phase

Not Applicable

Conditions

Urinary Incontinence

Interventions

Magic Kegel app

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Mar 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Oct 4, 2016

First Submission Date that Met QC Criteria

Feb 1, 2017

First Posted Date

Feb 3, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2017

Last Update Posted Date

Feb 3, 2017Estimated

Name	Class
eCareYou Innovation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Unique arm	Other	Magic Kegel app	Device: Magic Kegel app

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magic Kegel app	Device	Pelvic floor muscles recover exercises with a specific device and Magic Kegel App	Unique arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in values registered in Magic Kegel App		Six months

Secondary Outcomes

Measure	Description	Time Frame
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 Sandvick questionnaire at month 2 respect to baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Urinary incontinence diagnosis

Exclusion Criteria:

No urinary infection
No surgery for urinary incontinence

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Santiago Palacios, MD	Instituto Palacios	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Palacios		Madrid	Madrid	28009	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014549	Urinary Incontinence

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided