Pilot Study for the Urinary Incontinence Treatment
February 1, 2017 updated by: Instituto Palacios
Pilot Study for the Urinary Incontinence Treatment by Using a Pelvic Floor Muscles Restorative Device (E-NNA®)
Non invasive study to improve the urinary incontinence, through pelvic floor muscles exercises
Study Overview
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 Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Madrid, Spain, 28009
- Instituto Palacios
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Urinary incontinence diagnosis
Exclusion Criteria:
- No urinary infection
- No surgery for urinary incontinence
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Unique arm
Magic Kegel app
|
Pelvic floor muscles recover exercises with a specific device and Magic Kegel App
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in values registered in Magic Kegel App
Time Frame: Six months
|
Six months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in ICIQ-SF questionnaire at month 2 respect to baseline
Time Frame: 60 days
|
60 days
|
|
Changes in FSFI questionnaire at month 2 respect to baseline
Time Frame: 60 days
|
60 days
|
|
Changes in Sandvick questionnaire at month 2 respect to baseline
Time Frame: 60 days
|
60 days
|
|
Changes in PISQ-12 questionnaire at month 2 respect to baseline
Time Frame: 60 days
|
60 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (ACTUAL)
March 1, 2016
Study Completion (ACTUAL)
September 1, 2016
Study Registration Dates
First Submitted
October 4, 2016
First Submitted That Met QC Criteria
February 1, 2017
First Posted (ESTIMATE)
February 3, 2017
Study Record Updates
Last Update Posted (ESTIMATE)
February 3, 2017
Last Update Submitted That Met QC Criteria
February 1, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IP-ENNA-2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.