Urinary IncontinenceNCT01276340
Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation of Female Urinary Incontinence
An observational study of Urinary Incontinence, run by Centre Hospitalier Universitaire de Saint Etienne at 6 sites in France.
Trial summary
The investigators performed a prospective analysis of 450 women with stress, urge and mixed incontinence in order to assess the health-related quality of life (Contilife® questionnaire) and the objective cure rate after two months of electrical stimulation (Keat® stimulator). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- KEAT stimulator
- Type of treatment
- Medical device
- How many people
- 450 participants
- Where
- 6 sitesFrance
- Study dates
- Sep 2010to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women with stress, urge and mixed incontinence with an indication for perineal reeducation follow in gynecology
Who may be able to join
- women
- age > 18 years
- stress, urge or mixed incontinence with indication of perineal reeducation
- follow in gynecology
Who cannot join
- incontinence due to neurological disorders
- younger than 18 years old
- pregnancy
- patient with pace-maker
- patient with gynecological cancer
- patient who don't understand the electrical stimulation procedure
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
CHU Dijon
Dijon, 21000
CHU Grenoble
Grenoble, 38000
CH Issoire
Issoire, 63500
CHU Limoges
Limoges, 87042
Hospices Civils de Lyon
Lyon, 69000
About this study
Official title: Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation
The investigators performed a prospective analysis of 450 women with stress, urge and mixed incontinence in order to assess the health-related quality of life (Contilife® questionnaire) and the objective cure rate after two months of electrical stimulation (Keat® stimulator). Management of urinary incontinence with the Keat® stimulator could given an improvement in the quality of life and a good rate of satisfaction without side effect.
Objective cure is as good as subjective improvement especially in urinary stress incontinence. Keat® stimulator is a non-invasive and simple new technique that could be the bew first-line non surgical treatment for female urinary incontinence.
- Conditions
- Urinary Incontinence
- Being tested
- KEAT stimulator
- Keywords
- Urinary Incontinence, Urinary stress incontinence, Urinary urge incontinence, Women, electrical stimulation, KEAT stimulator, quality of life
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KEAT stimulatorDevice
electrical stimulation with KEAT stimulator : 4 times per week during 2 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | women with urinary incontinence Receives: Device: KEAT stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of quality of life after electrostimulation
Change from baseline in quality of life after 2 months of electrostimulation Measurement of health-related quality of life with "contilife" questionnaire
Measured: 2 months
Secondary outcomes (2)
change of urinary handicap after electrostimulation
Change from baseline in urinary handicap after 2 months of electr-st-imulation. Measurement of urinary handicap with "MHU" questionnaire
Measured: 2 months
satisfaction after electrostimulation
description of patient's satifaction 2 months after electrostimulation by satisfaction questionaire
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gautier CHENE, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276340
- Sponsor's protocol ID
- 1008433
- Status last verified
- May 2012
- First submitted
- 11 Jan 2011
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation
- ClinicalTrials.gov ID
- NCT01276340
- Acronym / sponsor ID
- 1008433
- Conditions
- Urinary Incontinence
- Keywords
- Urinary Incontinence, Urinary stress incontinence, Urinary urge incontinence, Women, electrical stimulation, KEAT stimulator, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators performed a prospective analysis of 450 women with stress, urge and mixed incontinence in order to assess the health-related quality of life (Contilife® questionnaire) and the objective cure rate after two months of electrical stimulation (Keat® stimulator). Management of urinary incontinence with the Keat® stimulator could given an improvement in the quality of life and a good rate of satisfaction without side effect.
Objective cure is as good as subjective improvement especially in urinary stress incontinence. Keat® stimulator is a non-invasive and simple new technique that could be the bew first-line non surgical treatment for female urinary incontinence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: KEAT stimulatorwomen with urinary incontinence |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with stress, urge and mixed incontinence with an indication for perineal reeducation follow in gynecology
Key inclusion criteria (4 listed)
- women
- age > 18 years
- stress, urge or mixed incontinence with indication of perineal reeducation
- follow in gynecology
Key exclusion criteria (6 listed)
- incontinence due to neurological disorders
- younger than 18 years old
- pregnancy
- patient with pace-maker
- patient with gynecological cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KEAT stimulatorelectrical stimulation with KEAT stimulator : 4 times per week during 2 months | Device | 1 |
Primary outcome
change of quality of life after electrostimulation
Time frame: 2 months
Change from baseline in quality of life after 2 months of electrostimulation Measurement of health-related quality of life with "contilife" questionnaire
2 secondary outcomes
change of urinary handicap after electrostimulation
Time frame: 2 months
satisfaction after electrostimulation
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gautier CHENE, MD principal investigator
CHU de Saint-Etienne
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by Centre Hospitalier Universitaire de Saint Etienne at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of quality of life after electrostimulation (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2012.