NCT03042351

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 4, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

Same day

First QC Date

October 4, 2016

Last Update Submit

February 1, 2017

Conditions

Urinary Incontinence

Keywords

Urinary IncontinencePelvic Floor

Outcome Measures

Primary Outcomes (1)

  • Changes in values registered in Magic Kegel App

    Six months

Secondary Outcomes (4)

  • 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

    60 days

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

    60 days

Study Arms (1)

Unique arm

OTHER

Magic Kegel app

Device: Magic Kegel app

Interventions

Magic Kegel appDEVICE

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

Unique arm

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Urinary incontinence diagnosis

You may not qualify if:

  • No urinary infection
  • No surgery for urinary incontinence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Palacios

Madrid, Madrid, 28009, Spain

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Santiago Palacios, MD

    Instituto Palacios

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2016

First Posted

February 3, 2017

Study Start

March 1, 2016

Primary Completion

March 1, 2016

Study Completion

September 1, 2016

Last Updated

February 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)