Efficacy of Sacral Nerve Modulation in Severe Refractory Constipation (CONSTIMOD)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Constipation |
Procedure: sacral nerve modulation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy of Sacral Nerve Modulation in Severe Refractory Constipation |
- Percentage of patients showing a positive response to sacral nerve stimulation at 2 months [ Time Frame: 2 months of the stimualtion period ] [ Designated as safety issue: No ]Percentage of patients showing a positive response to sacral nerve stimulation during the period " ON " compared with the period " OFF "
- Clinical characteristics, manometry data, Wexner score of responders to stimulation during the temporary stimulation test (period before the permanent implantation) [ Time Frame: 3 weeks between temporary and permanent implantations ] [ Designated as safety issue: No ]
- Clinical characteristics, manometry data, Wexner score of responders to short-term stimulation [ Time Frame: 2 months after permanent implantation ] [ Designated as safety issue: No ]
- Efficacy of neuromodulation [ Time Frame: 1 year after permanent implantation ] [ Designated as safety issue: No ]Efficacy of neuromodulation (percentage of positive responders) at 1 year
- Manometry data, Wexner, QoL and EVA scores, time of colonic transit of responders to prolonged stimulation [ Time Frame: 1 year after permanent implantation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm on-off
After 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 |
Procedure: sacral nerve modulation
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 |
|
Experimental: Arm off-on
After 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 |
Procedure: sacral nerve modulation
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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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)
Contacts and Locations| Contact: Frank ZERBIB, Professor | +33(0)5 56 79 58 06 | frank.zerbib@chu-bordeaux.fr |
| Contact: Patricia LE PICARD | 33(0)5 56 79 58 06 | patricia.lepicard@chu-bordeaux.fr |
| France | |
| Service d' Hépato-gastro-entérologie | Recruiting |
| CHU de Limoges, Limoges, France, 87000 | |
| Contact: Muriel MATHONNET mathonnet@unilim.fr | |
| Principal Investigator: Muriel Mathonnet | |
| Sub-Investigator: Anne Le Sidaner | |
| Service d'hépato-gastroentérologie et oncologie digestive | Recruiting |
| Bordeaux, France, 33075 | |
| Contact: Frank ZERBIB, PU PH +33(0)5 56 79 58 06 frank.zerbib@chu-bordeaux.fr | |
| Principal Investigator: Frank ZERBIB, PU Ph | |
| Sub-Investigator: Quentin DENOST, MD | |
| Service d'hépato-gastroentérologie - CHU estaing | Not yet recruiting |
| Clermont Ferrand, France, 63000 | |
| Contact: Michel DAPOIGNY mdapoigny@chu-clermontferrand.fr | |
| Principal Investigator: Michel DAPOIGNY | |
| Sub-Investigator: Karem SLIM | |
| Service de gastroentérologie - AP HP | Recruiting |
| Colombes, France, 92000 | |
| Contact: Benoit COFFIN, PUPH benoit.coffin@lmr.aphp.fr | |
| Principal Investigator: Benoit Coffin | |
| Sub-Investigator: Benjamin Castel | |
| Service de Chirurgie générale - CHU de Grenoble | Recruiting |
| Grenoble, France, 38000 | |
| Contact: Jean Luc FAUCHERON JLFaucheron@chu-grenoble.fr | |
| Principal Investigator: Jean Luc Faucheron | |
| Sub-Investigator: Bruno Bonaz | |
| Service d'exploration fonctionnelle digestive -Hospices Civils de Lyon | Recruiting |
| Lyon, France, 69000 | |
| Contact: francois MION, PUPH francois.mion@chu-lyon.fr | |
| Principal Investigator: Francois MION | |
| Sub-Investigator: Sabine ROMAN | |
| Service de gastroentérologie - hopital nord -AP-HM | Recruiting |
| Marseille, France, 13000 | |
| Contact: Véronique VITTON veronique.vitton@ap-hm.fr | |
| Sub-Investigator: Jean-Charles Grimaud | |
| Principal Investigator: Véronique Vitton | |
| : Clinique de chirurgie digestive et endocrinienne. Institut des Maladies de l'Appareil Digestif (IMAD | Recruiting |
| Nantes, France, 44000 | |
| Contact: Paul Antoine LEHUR, PUPH paulantoine.lehur@chu-nantes.fr | |
| Principal Investigator: Paul Antoine LEHUR, PUPH | |
| Sub-Investigator: Stanilas BRULEY DES VARANNES, PUPH | |
| SMAD CHU Pontchaillou -Rennes | Recruiting |
| Rennes, France, 35000 | |
| Contact: Laurent SIPROUDHIS laurent.siproudhis@chu-rennes.fr | |
| Principal Investigator: Laurent SIPROUDHIS | |
| Sub-Investigator: Véronique DESFOURNEAUX | |
| Service de physiologie digestive, urinaire, respiratoire et sportive - CHU de rouen | Recruiting |
| Rouen, France, 76000 | |
| Contact: Anne-Marie LEROI anne-marie.leroi@chu-rouen.fr | |
| Principal Investigator: Anne-Marie Leroi | |
| Sub-Investigator: Guillaume Gourcerol | |
| Service d'hépato-gastroentérologie et explorations fonctionnelles digestives - CHU de Tours | Not yet recruiting |
| Tours, France, 37000 | |
| Contact: Jean-Pierre BARBIEUX barbieux@med.univ-tours.fr | |
| Principal Investigator: Jean-Pierre BARBIEUX | |
| Sub-Investigator: Noel Huten | |
| Principal Investigator: | Frank ZERBIB, Professor | University Hospital, Bordeaux |
| Study Chair: | Genevieve CHENE, Professor | University Hospital, Bordeaux |
More Information
No publications provided
| Responsible Party: | University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT01629303 History of Changes |
| Other Study ID Numbers: | CHUBX 2011/23 |
| Study First Received: | June 11, 2012 |
| Last Updated: | January 10, 2013 |
| Health Authority: | France: Agence Nationale de Sécurité du Médicament et des produits de santé |
Keywords provided by University Hospital, Bordeaux:
|
constipation sacral nerve modulation |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013