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Efficacy of Interferential Therapy in Chronic Constipation (CON-COUR) (CON-COUR)

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ClinicalTrials.gov Identifier: NCT02381665
Recruitment Status : Unknown
Verified March 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Not yet recruiting
First Posted : March 6, 2015
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date  ICMJE February 13, 2015
First Posted Date  ICMJE March 6, 2015
Last Update Posted Date March 6, 2015
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
Number of stool [ Time Frame: 8 weeks ]
Assessing the short-term efficacy of interferential therapy in adult patients with severe chronic constipation.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Interferential Therapy in Chronic Constipation (CON-COUR)
Official Title  ICMJE INTERFERENTIAL THERAPY IN THE TREATMENT OF CHRONIC CONSTIPATION IN ADULTS: A RANDOMIZED MULTI-CENTER TRIAL
Brief Summary

Chronic constipation is a strong public health problem. Its prevalence is about 15% in Western countries with a significant impact on quality of life and health care costs . Two subtypes of constipation can be identified: slow transit constipation (STC), characterized by impaired propulsion of stool and due to dysfunction of colonic smooth muscle (myopathy) or its innervation (neuropathy), or both; and evacuation disorders, characterized by difficulty or inability with stool expulsion. They include disorders of the anorectal function such as dyssynergic defecation, as well as structural disorders such as rectocele, descending perineum syndrome and rectal prolapse .

The first line therapy of chronic constipation is based on medical treatment combined with laxatives and dietary rules. However, these treatments are often disappointing. In case of failure, few treatment options are currently available. Surgery can sometimes be discussed for intractable chronic constipation. Sub-total colectomy can be proposed in case of STC but is associated with a significant morbidity. In case of pelvic floor disorders, a specific surgical treatment can be indicated. However, surgery is invasive, has a significant morbidity and the results are inconsistent. Recently, some studies have assessed the efficacy of sacral neuromodulation in the treatment of chronic constipation with some success, but this technique is expensive and requires the surgical implantation of a medical device . More recent works, including a randomized trial have showed, in children, the efficacy of interferential current stimulation in the treatment of chronic transit constipation . This treatment is used daily, at home, and uses four adhesive surface electrodes, two abdominal (placed below the costal margin) and two paraspinal (placed between T9 and L2) producing two sinusoidal currents crossing the body, 1 hour per day for 1-3 months. To date, only one open-label study has evaluated this technique in adults and has shown encouraging results in three months with an efficiency on 7/11 patients (63.6%) in the number of stools, severity score of constipation, quality of life's score associated with improved bowel transit time measured by radio-markers.

Interferential therapy is a new treatment that has demonstrated its efficiency in the treatment of chronic constipation in children. Our team has published the first and only pilot study in adults that also demonstrated encouraging results. These data are of particular interest since laxative treatments are often disappointing, are expensive and may have adverse events.

This study would be the first randomized study to evaluate a non-invasive and non-pharmacological treatment of chronic constipation in adults.

If its effectiveness is demonstrated, it will provide, for the first time, a new non-invasive step for patients with laxative treatment failure before considering surgical treatment.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Constipation Symptoms
Intervention  ICMJE
  • Device: Flexstim IF
    Patient enrolled will receive a device for effective interferential current stimulation
  • Device: Flexstim IF faked
    Patient enrolled will receive a sham device.
Study Arms  ICMJE
  • Experimental: Group A
    Patient enrolled in this group will receive a device for effective interferential current stimulation.
    Intervention: Device: Flexstim IF
  • Placebo Comparator: Group B
    Patient enrolled in this group will receive a device that does not deliver current stimulation
    Intervention: Device: Flexstim IF faked
Publications * Vitton V, Benezech A, Honoré S, Sudour P, Lesavre N, Auquier P, Baumstarck K. CON-COUR study: Interferential therapy in the treatment of chronic constipation in adults: study protocol for a randomized controlled trial. Trials. 2015 May 28;16:234. doi: 10.1186/s13063-015-0752-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 2, 2015)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subject with a history of chronic constipation defined as:

  • two or fewer spontaneous, complete bowel movements per week for a minimum of 6 months before the screening visit*
  • or as a sensation of incomplete evacuation or straining during defecation with at least 25% bowel movements*
  • Subject with chronic constipation lasting for more than 6 months
  • Subject with chronic constipation refractory to medical treatment for at least 3 months (failure or intolerance of medical treatment)
  • Subject have to interrupt any laxative treatment but during the study, patients are allowed, in case of absence of bowel movements for 3 or more consecutive days, to take up 15 mg of bisacodyl (Dulcolax, Boerhinger Ingelheim) as rescue medication
  • Subjects affiliated to or beneficiary of a social security system
  • Subjects who have signed written informed consent

Exclusion Criteria:

  • - Minors or pregnant or breast-feeding women
  • Subject with chronic constipation secondary to anorectal malformations, to colorectal or anal organic lesions or to a pelvic floor disorder considered by the investigator as necessitating a surgical treatment (rectal prolapse exteriorized, rectocele, enterocele)
  • Subjects with current implanted cardiac pacemakers, defibrillators, cardiac pumps, spinal stimulators or other implanted electronic devices
  • Subject with chronic constipation secondary to drug, to neurologic, endocrine or metabolic disorders
  • Subject with a history of partial colectomy
  • Subject with megacolon, megarectum, colonic inertia
  • Skin lesions preventing the installation of the electrodes
  • Women without effective contraception (hormonal or intra-uterine device)
  • Subject misunderstanding the written and spoken French
  • Subject participating in another biomedical research protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02381665
Other Study ID Numbers  ICMJE 2014-14
2014-A01359-38 ( Registry Identifier: Ansm )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Urielle DESALBRES Assistance Publique Hopitaux De Marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP