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ConstipationPhase 2CONSTIMODNCT01629303

Efficacy of Sacral Nerve Modulation in Severe Refractory Constipation

A Phase 2 study testing sacral nerve modulation in people with Constipation, run by University Hospital, Bordeaux at 11 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Subjects with refractory chronic constipation are offered two conventional therapeutic strategies: either medical treatment, either surgery (in the case of medication failure). Nevertheless, a procedure less invasive than surgery could be an alternative strategy: the sacral nerve modulation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Constipation
What is being tested?
sacral nerve modulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
11 sitesFrance
Study dates
Jun 2012to Jan 2015
Phase
Phase 2
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old
  • Constipation defined by at least two of the following criteria :
  • Frequency of 2 stools or less per week
  • Severe outlet constipation, i.e. need to use digital extraction or enemas more than 25% of time
  • Sensation of incomplete evacuation more than 25% of time
  • Refractory constipation since at least 1 year to medical treatment (drug treatment and/or biofeedback) conducted in the centre (failure or intolerance to laxative osmotic treatments, stimulants, and prucalopride) for which surgery is discussed
Show all 9Show fewer
  • Patients supported in the centre for at least 3 months before inclusion
  • Patients having social security system
  • Patients having read and signed informed consent form

Who cannot join

  • Constipation secondary to ano-rectal malformation, surgical sequel, colorectal or anal organic lesions, or pelvi-perineal static disorder indicated for surgical treatment
  • Constipation secondary to neurological pathology and/or concomitant treatments intake (opiates, anticholinergic agents)
  • Partial colectomy history
  • Patients in whom implantation of stimulating electrode is impossible due to anatomical reasons (e.g. sacral agenesis)
  • Pregnant female patients or with childbearing potential without adequate contraceptive barrier (oestrogen-progesterone contraceptives or intra-uterine device)
  • Skin disease associated with a risk of infection - in the opinion of the investigator
Show all 12Show fewer
  • Patient with pacemaker or defibrillator
  • Patient exposed to resonance magnetic imaging
  • Psychiatric disease incompatible with use of the treatment - in the opinion of the investigator
  • Patient misunderstanding oral and written French language
  • Patient participating to another study
  • Patients who don't complete the first diary without missing data (concerning items used to define the primary endpoint)

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

France11 sites

  • Service d'hépato-gastroentérologie et oncologie digestive

    Bordeaux, Bordeaux, 33075

  • Service d' Hépato-gastro-entérologie

    CHU de Limoges, Limoges, 87000

  • Service d'hépato-gastroentérologie - CHU estaing

    Clermont-Ferrand, 63000

  • Service de gastroentérologie - AP HP

    Colombes, 92000

  • Service de Chirurgie générale - CHU de Grenoble

    Grenoble, 38000

  • Service d'exploration fonctionnelle digestive -Hospices Civils de Lyon

    Lyon, Lyon, 69000

  • Service de gastroentérologie - hopital nord -AP-HM

    Marseille, 13000

  • : Clinique de chirurgie digestive et endocrinienne. Institut des Maladies de l'Appareil Digestif (IMAD

    Nantes, Nantes, 44000

  • SMAD CHU Pontchaillou -Rennes

    Rennes, 35000

  • Service de physiologie digestive, urinaire, respiratoire et sportive - CHU de rouen

    Rouen, 76000

  • Service d'hépato-gastroentérologie et explorations fonctionnelles digestives - CHU de Tours

    Tours, 37000

Other trials in France

About this study

Subjects with refractory chronic constipation are offered two conventional therapeutic strategies: either medical treatment, either surgery (in the case of medication failure). Nevertheless, a procedure less invasive than surgery could be an alternative strategy: the sacral nerve modulation. This procedure consists in stimulating the nerves which control the contractions of the colon and so the defecation phenomenon. Several open trials have suggested that sacral nerve modulation may be effective in reducing constipation and related symptoms. The aim of this randomized clinical trial is to assess the efficacy of the sacral nerve stimulation in patients with constipation.

Read the detailed description

The prevalence of constipation is 2-27% in Western countries. For patients failing medical treatment (laxatives, biofeedback), a surgical solution may be considered (subtotal colectomy). But results are variable and it puts them at risk of functional sequelae.

Sacral nerve modulation is a minimally invasive procedure compared with the standard surgical support (colectomy) and reversible, which consists in two stages. First, a 3-week temporary stimulation test allows verifying the efficacy of neuromodulation. If the test is positive, the stimulating electrode is definitely implanted. Risks related to the procedure (infection, pain) are much smaller than those associated with a conventional surgical support.

Non comparative studies conducted with 19 and 62 patients showed that 40-73% of implanted patients have an improvement of their constipation and could benefit of permanent implantation with good results in medium term.

The primary objective of the investigators study is to evaluate the short-term efficacy (percentage of responders at 2 months) of sacral nerve modulation in the treatment of severe chronic constipation.

This is a cross-over designed, double-blinded, French multicenter clinical trial, including two periods: 2 months of stimulation ON and 2 months of stimulation OFF. Between these two periods, a 15-days period of "wash-out" will be respected during which all patients will be in OFF mode (4.5 months in total). This period of 4.5 months will be extended by a follow-up period of 7 months during which all patients will be treated (stimulation ON).

If this trial showed efficiency of this procedure, patients with severe refractory constipation could benefit of a sacral nerve modulation test before considering a surgical treatment.

Conditions
Constipation
Being tested
sacral nerve modulation
Keywords
constipation, sacral nerve modulation
Medical subject headings
Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sacral nerve modulationProcedure or surgery

    After the definitive implantation, stimulators are placed in position ON (arm on-off) or OFF (arm off-on) for the first arm and in position OFF for the second arm during 8 weeks.

    Then all the stimulators are switched OFF (both first and second arms) for 15 days.

    Finally stimulators are maintained in position OFF for the first arm and switched ON for the second arm during 8 weeks

Study groups in NCT01629303
Study groupRoleWhat they receive
Arm on-offExperimentalAfter the definitive implantation, stimulators are placed in position OFF during 8 weeks. Then all the stimulators are switched OFF for 15 days. Finally stimulators are switched ON for the second arm during 8 weeks
Receives: Procedure: sacral nerve modulation
Arm off-onExperimentalAfter the definitive implantation, stimulators are placed in position ON during 8 weeks. Then all the stimulators are switched OFF for 15 days. Finally stimulators are maintained in position OFF during 8 weeks
Receives: Procedure: sacral nerve modulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients showing a positive response to sacral nerve stimulation at 2 months

    Percentage of patients showing a positive response to sacral nerve stimulation during the period " ON " compared with the period " OFF " based on an objective assessment of the number of feces and their characteristics

    Measured: 2 months of the stimualtion period

Secondary outcomes (5)

  1. Clinical characteristics, manometry data, Wexner score of responders to stimulation during the temporary stimulation test (period before the permanent implantation)

    Measured: 3 weeks between temporary and permanent implantations

  2. Clinical characteristics, manometry data, Wexner score of responders to short-term stimulation

    Measured: 2 months after permanent implantation

  3. Efficacy of neuromodulation

    Efficacy of neuromodulation (percentage of positive responders) at 1 year

    Measured: 1 year after permanent implantation

  4. Manometry data, Wexner, QoL and EVA scores, time of colonic transit of responders to prolonged stimulation

    Measured: 1 year after permanent implantation

  5. To evaluate the investigator opinion about the neuromodulation response, using the patient diary.

    Measured: 1 year after permanent implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionNov 2013
  4. Study completionJan 2015

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01629303
Sponsor's protocol ID
CHUBX 2011/23
Acronym
CONSTIMOD
Status last verified
Jul 2015
First submitted
11 Jun 2012
Last updated
23 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Zerbib F, Siproudhis L, Lehur PA, Germain C, Mion F, Leroi AM, Coffin B, Le Sidaner A, Vitton V, Bouyssou-Cellier C, Chene G; CONSTIMOD study investigators. Randomized clinical trial of sacral nerve stimulation for refractory constipation. Br J Surg. 2017 Feb;104(3):205-213. doi: 10.1002/bjs.10326. Epub 2016 Oct 25.

    PubMed 27779312

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sacral nerve modulation in people with Constipation, run by University Hospital, Bordeaux at 11 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 9 inclusion and 12 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 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Percentage of patients showing a positive response to sacral nerve stimulation at 2 months (time frame: 2 months of the stimualtion period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01629303, which also lists 1 linked publication.

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 23 Jul 2015.

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