Back to results

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

Primary Purpose

Constipation

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

sacral nerve modulation

About this trial

This is an interventional treatment trial for Constipation focused on measuring constipation, sacral nerve modulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Service d' Hépato-gastro-entérologie
Service d'hépato-gastroentérologie et oncologie digestive
Service d'hépato-gastroentérologie - CHU estaing
Service de gastroentérologie - AP HP
Service de Chirurgie générale - CHU de Grenoble
Service d'exploration fonctionnelle digestive -Hospices Civils de Lyon
Service de gastroentérologie - hopital nord -AP-HM
: Clinique de chirurgie digestive et endocrinienne. Institut des Maladies de l'Appareil Digestif (IMAD
SMAD CHU Pontchaillou -Rennes
Service de physiologie digestive, urinaire, respiratoire et sportive - CHU de rouen
Service d'hépato-gastroentérologie et explorations fonctionnelles digestives - CHU de Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm on-off

Arm off-on

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Efficacy of neuromodulation

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

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

Full Information

NCT ID

NCT01629303

First Posted

June 11, 2012

Last Updated

July 22, 2015

Sponsor

University Hospital, Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT01629303

Brief Title

Efficacy of Sacral Nerve Modulation in Severe Refractory Constipation

Acronym

CONSTIMOD

Official Title

Efficacy of Sacral Nerve Modulation in Severe Refractory Constipation

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

Keywords

constipation, sacral nerve modulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm on-off

Arm Type

Experimental

Arm Description

Arm Title

Arm off-on

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

sacral nerve modulation

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

2 months of the stimualtion period

Secondary Outcome Measure Information:

Title

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

Title

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

Time Frame

2 months after permanent implantation

Title

Efficacy of neuromodulation

Description

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

Time Frame

1 year after permanent implantation

Title

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

Time Frame

1 year after permanent implantation

Title

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

Time Frame

1 year after permanent implantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frank ZERBIB, Professor

Organizational Affiliation

University Hospital, Bordeaux

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Genevieve CHENE, Professor

Organizational Affiliation

University Hospital, Bordeaux

Official's Role

Study Chair

Facility Information:

Facility Name

Service d' Hépato-gastro-entérologie

City

CHU de Limoges

State/Province

Limoges

ZIP/Postal Code

87000

Country

France

Facility Name

Service d'hépato-gastroentérologie et oncologie digestive

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

Service d'hépato-gastroentérologie - CHU estaing

City

Clermont Ferrand

ZIP/Postal Code

63000

Country

France

Facility Name

Service de gastroentérologie - AP HP

City

Colombes

ZIP/Postal Code

92000

Country

France

Facility Name

Service de Chirurgie générale - CHU de Grenoble

City

Grenoble

ZIP/Postal Code

38000

Country

France

Facility Name

Service d'exploration fonctionnelle digestive -Hospices Civils de Lyon

City

Lyon

ZIP/Postal Code

69000

Country

France

Facility Name

Service de gastroentérologie - hopital nord -AP-HM

City

Marseille

ZIP/Postal Code

13000

Country

France

Facility Name

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

City

Nantes

ZIP/Postal Code

44000

Country

France

Facility Name

SMAD CHU Pontchaillou -Rennes

City

Rennes

ZIP/Postal Code

35000

Country

France

Facility Name

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

City

Rouen

ZIP/Postal Code

76000

Country

France

Facility Name

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

City

Tours

ZIP/Postal Code

37000

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

27779312

Citation

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.

Results Reference

derived

Learn more about this trial

Efficacy of Sacral Nerve Modulation in Severe Refractory Constipation

We'll reach out to this number within 24 hrs