Trial record 4 of 103 for:    Open Studies | "Constipation"

Efficacy of Sacral Nerve Modulation in Severe Refractory Constipation (CONSTIMOD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01629303
First received: June 11, 2012
Last updated: March 19, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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 " based on an objective assessment of the number of feces and their characteristics


Secondary Outcome Measures:
  • 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 ]
  • To evaluate the investigator opinion about the neuromodulation response, using the patient diary. [ 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629303

Contacts
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

Locations
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         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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: March 19, 2014
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 September 18, 2014