NCT01629303

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 27, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

1.4 years

First QC Date

June 11, 2012

Last Update Submit

July 22, 2015

Conditions

Constipation

Keywords

constipationsacral nerve modulation

Outcome Measures

Primary Outcomes (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

    2 months of the stimualtion period

Secondary Outcomes (5)

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

    3 weeks between temporary and permanent implantations

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

    2 months after permanent implantation

  • Efficacy of neuromodulation

    1 year after permanent implantation

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

    1 year after permanent implantation

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

    1 year after permanent implantation

Study Arms (2)

Arm on-off

EXPERIMENTAL

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

Arm off-on

EXPERIMENTAL

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

Interventions

sacral nerve modulationPROCEDURE

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

Arm off-onArm on-off

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 having social security system
  • Patients having read and signed informed consent form

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Service d'hépato-gastroentérologie et oncologie digestive

Bordeaux, Bordeaux, 33075, France

Location

Service d' Hépato-gastro-entérologie

CHU de Limoges, Limoges, 87000, France

Location

Service d'exploration fonctionnelle digestive -Hospices Civils de Lyon

Lyon, Lyon, 69000, France

Location

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

Nantes, Nantes, 44000, France

Location

Service d'hépato-gastroentérologie - CHU estaing

Clermont-Ferrand, 63000, France

Location

Service de gastroentérologie - AP HP

Colombes, 92000, France

Location

Service de Chirurgie générale - CHU de Grenoble

Grenoble, 38000, France

Location

Service de gastroentérologie - hopital nord -AP-HM

Marseille, 13000, France

Location

SMAD CHU Pontchaillou -Rennes

Rennes, 35000, France

Location

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

Rouen, 76000, France

Location

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

Tours, 37000, France

Location

Related Publications (1)

  • 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.

    PMID: 27779312DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Frank ZERBIB, Professor

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Genevieve CHENE, Professor

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 27, 2012

Study Start

June 1, 2012

Primary Completion

November 1, 2013

Study Completion

January 1, 2015

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations

FR(11)