Urinary IncontinenceReedPerineeNCT02899520
Evaluation of Programs of Reeducation for Urinary Incontinence in Woman
A study testing Reference method and CMP ® method in people with Urinary Incontinence, run by Hopital Foch at 1 site in France.
Trial summary
The objective of this study is to compare two methods of pelvic floor muscle training: reference method versus CMP ® method ( (Connaissance et Maîtrise de Périnée : Knowledge and Control of Perineum) Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Reference method and CMP ® method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 10 Nov 2014to 18 Oct 2019
- Phase
- Interventional
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients more than 18 years old and less than 75 years
- Patients presenting an urinary incontinence of effort or mixed symptomatic associated with a pelvic statics disorder
- Patients with a perineale reeducation prescription
- Patients affiliated to a national insurance scheme or benefiting from such a program
- Patients having given her written consent form
Who cannot join
- Nulliparous woman
- Patients already operated for their incontinence
- Patients with a prolapse of higher level at the stage II of the classification POP-Q (Pelvic Organ Prolapse Quantification)
- Pregnant women
- Patients presenting an associated anal incontinence,
- Patients presenting a cancellation (section of marrow, syringomyelia for example) or an inversion of perineum control
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- Patients having given birth less than 6 months before the care
- Patients having benefited from a pelvi-périnéale reeducation in the previous 12 months,
- Patients presenting psychiatric disease
- Patients presenting a vaginismus,
- Patients presenting a contraindication to the practice of the electrostimulation.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to compare two methods of pelvic floor muscle training: reference method versus CMP ® method ( (Connaissance et Maîtrise de Périnée : Knowledge and Control of Perineum)
- Conditions
- Urinary Incontinence
- Being tested
- Reference method, CMP ® method
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference methodOther
Electrostimulation associated to perineal training
CMP ® methodOther
Method based on Knowledge and Control of Perineum
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Reference method Receives: Other: Reference method |
| Group B | Experimental | CMP ® method (Knowledge and Control of Perineum) Receives: Other: CMP ® method |
What is being measured
The primary outcome is the main question the study is designed to answer.
USP (Urinary Symptoms Profile) score
Urinary Symptoms Profile score
Measured: 38 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start10 Nov 2014
- Primary completion18 Oct 2019
- Study completion18 Oct 2019
Why it stopped: Change in the clinical practices
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie FLANDIN-CRETINON, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899520
- Sponsor's protocol ID
- 2014/09
- Other IDs
- 2014-A00709-38
- Acronym
- ReedPerinee
- Status last verified
- Dec 2019
- First submitted
- 9 Sep 2016
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Programs of Reeducation for Urinary Incontinence in Woman
- ClinicalTrials.gov ID
- NCT02899520
- Acronym / sponsor ID
- ReedPerinee / 2014/09
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in the clinical practices
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 10 Nov 2014 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 14 Sep 2016 (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 objective of this study is to compare two methods of pelvic floor muscle training: reference method versus CMP ® method ( (Connaissance et Maîtrise de Périnée : Knowledge and Control of Perineum)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Reference methodReference method |
| Group B | Experimental | Other: CMP ® methodCMP ® method (Knowledge and Control of Perineum) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients more than 18 years old and less than 75 years
- Patients presenting an urinary incontinence of effort or mixed symptomatic associated with a pelvic statics disorder
- Patients with a perineale reeducation prescription
- Patients affiliated to a national insurance scheme or benefiting from such a program
- Patients having given her written consent form
Key exclusion criteria (11 listed)
- Nulliparous woman
- Patients already operated for their incontinence
- Patients with a prolapse of higher level at the stage II of the classification POP-Q (Pelvic Organ Prolapse Quantification)
- Pregnant women
- Patients presenting an associated anal incontinence,
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 |
|---|---|---|
| Reference methodElectrostimulation associated to perineal training | Other | Group A |
| CMP ® methodMethod based on Knowledge and Control of Perineum | Other | Group B |
Primary outcome
USP (Urinary Symptoms Profile) score
Time frame: 38 weeks
Urinary Symptoms Profile score
Results and safety
The study was stopped early (reason given: Change in the clinical practices). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
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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.
Sophie FLANDIN-CRETINON principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reference method and CMP ® method in people with Urinary Incontinence, run by Hopital Foch at 1 site 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Change in the clinical practices). Results are not available in the source record.
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?
USP (Urinary Symptoms Profile) score (time frame: 38 weeks). 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 3 Jan 2020.