CClinicalTrials.gg
Status unknownNCT02381665CON-COURUpdated Mar 6, 2015

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

An interventional study of Flexstim IF and Flexstim IF faked in Chronic Constipation Symptoms, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-06.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Constipation Symptoms

Browse trials for

03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's planned enrollment of 200 is above the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Group A

    Patient enrolled in this group will receive a device for effective interferential current stimulation.

    Device: Flexstim IF

  • Placebo comparator
    Group B

    Patient enrolled in this group will receive a device that does not deliver current stimulation

    Device: Flexstim IF faked

Interventions

  • DeviceFlexstim IF

    Patient enrolled will receive a device for effective interferential current stimulation

  • DeviceFlexstim IF faked

    Patient enrolled will receive a sham device.

06

What researchers measure

Primary outcomes

  1. Number of stool

    Assessing the short-term efficacy of interferential therapy in adult patients with severe chronic constipation.

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Vitton V, Benezech A, Honore 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. PubMed 26012788 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02381665
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Mar 6, 2015
Start date
Mar 2015
Primary completion
Mar 2018 (estimated)
Completion
Mar 2019 (estimated)
Last update
Mar 6, 2015

Study contacts

Véronique VITTON, MD PhD
Contact
veronique.vitton@ap-hm.fr
+33431964349
Urielle DESALBRES
study director · Assistance Publique Hopitaux De Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion