IncontinenceBiofeedbackNCT00653887
Biofeedback and Cortical Excitability
A study testing Biofeedback in people with Incontinence and Constipation, run by University Hospital, Rouen at 1 site in France.
Trial summary
Looking for a modification of the cortical excitability of the motor area corresponding to the external anal sphincter after biofeedback sessions. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Incontinence, Constipation
- What is being tested?
- Biofeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Dec 2009
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers between 18 years old and 35 years old
- Right handed*
Who cannot join
- Pregnancy
- Pace-maker or other metallic piece implanted in the body
- Neurological disease
- Epilepsy
- Digestive disease
- Traumatic delivery
Show all 11Show fewer
- Anorectal surgery
- Biofeedback
- Psychiatric disease
- Treatment anti-epileptic, hypnotic, psychotropic
- Participation to a previous protocol within 1 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training
Looking for a modification of the cortical excitability of the motor area corresponding to the external anal sphincter after biofeedback sessions.
Read the detailed description
Introduction: Nervous control of pelvic floor is not much known. The dysfunction of this musculature, and particularly of the external anal sphincter, is a frequent cause of anal incontinence and/or dyschesia. Biofeedback training is often offered to patients suffering from incontinence or constipation. However, its mechanisms of action is still controversial.
Objective of the study: to compare excitability of the cortical area responsible for control volunteer of the external anal sphincter in healthy subjects before and after 4 biofeedback sessions.
Subjects and methodology: we offer to perform two groups of 12 healthy subjects (one active and one control group) without any neurological or digestive disease and having never performed biofeedback. In each group, cortical excitability will be evaluated by cortical magnetic stimulation (curve intensity/amplitude, silent period, inter-stimulus period, motor threshold) before and after 4 biofeedback sessions (one session by week) in active group or 4 placebo sessions (placebo group).
We hope to show a modification of cortical excitability in subjects performing biofeedback compared to others.
- Conditions
- Incontinence, Constipation
- Being tested
- Biofeedback, Placebo
- Keywords
- Biofeedback, anal sphincter, cortical excitability, magnetic stimulation, incontinence, constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackOther
4 sessions of biofeedback one session each week
PlaceboOther
4 sessions, one each week, of discussion about anorectal disease
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | biofeedback (active group) Receives: Other: Biofeedback |
| B | Placebo comparator | discussion about digestive tract (placebo group) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction
Measured: final
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2009
- Study completionDec 2009
Why it stopped: Procedure needs to be changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- Coloplast A/S
- Investigators
- Anne-Marie LEROI, PhD, Principal investigator, CHU Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653887
- Sponsor's protocol ID
- 2007/054/HP
- Other IDs
- 2007- A00652-51
- Acronym
- Biofeedback
- Status last verified
- Feb 2012
- First submitted
- 2 Apr 2008
- Last updated
- 16 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training
- ClinicalTrials.gov ID
- NCT00653887
- Acronym / sponsor ID
- Biofeedback / 2007/054/HP
- Conditions
- Incontinence, Constipation
- Keywords
- Biofeedback, anal sphincter, cortical excitability, magnetic stimulation, incontinence, constipation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Procedure needs to be changed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Coloplast A/S
- Study start
- Jan 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 7 Apr 2008 (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.
Looking for a modification of the cortical excitability of the motor area corresponding to the external anal sphincter after biofeedback sessions.
Detailed description
Introduction: Nervous control of pelvic floor is not much known. The dysfunction of this musculature, and particularly of the external anal sphincter, is a frequent cause of anal incontinence and/or dyschesia. Biofeedback training is often offered to patients suffering from incontinence or constipation. However, its mechanisms of action is still controversial.
Objective of the study: to compare excitability of the cortical area responsible for control volunteer of the external anal sphincter in healthy subjects before and after 4 biofeedback sessions.
Subjects and methodology: we offer to perform two groups of 12 healthy subjects (one active and one control group) without any neurological or digestive disease and having never performed biofeedback. In each group, cortical excitability will be evaluated by cortical magnetic stimulation (curve intensity/amplitude, silent period, inter-stimulus period, motor threshold) before and after 4 biofeedback sessions (one session by week) in active group or 4 placebo sessions (placebo group).
We hope to show a modification of cortical excitability in subjects performing biofeedback compared to others.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Other: Biofeedbackbiofeedback (active group) |
| B | Placebo comparator | Other: Placebodiscussion about digestive tract (placebo group) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers between 18 years old and 35 years old
- Right handed*
Key exclusion criteria (11 listed)
- Pregnancy
- Pace-maker or other metallic piece implanted in the body
- Neurological disease
- Epilepsy
- Digestive disease
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 |
|---|---|---|
| Biofeedback4 sessions of biofeedback one session each week | Other | A |
| Placebo4 sessions, one each week, of discussion about anorectal disease | Other | B |
Primary outcome
external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction
Time frame: final
Results and safety
The study was stopped early (reason given: Procedure needs to be changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2012.
Related trials for Incontinence
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruiting
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
Faecal Incontinence With Faecal Urgency, Rectal Cancer
RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Active, not recruiting
A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
Stress Urinary Incontinence (SUI)
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.
Anne-Marie LEROI, PhD principal investigator
CHU Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback in people with Incontinence and Constipation, run by University Hospital, Rouen 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 2 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 16 Feb 2012. 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. Some participants in this study may receive a placebo. 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: Procedure needs to be changed). 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?
external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction (time frame: final). 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 16 Feb 2012.