Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence (TENSIA)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Anne Marie LEROI, University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00977652
First received: September 15, 2009
Last updated: August 22, 2011
Last verified: August 2011
  Purpose

Fecal incontinence is a major public health issue since 10% of the French population aged 45 has to deal with it. Different treatments exist and have already been evaluated, like the sacral nerve stimulation (SNS) which has proved to be efficient in 75 to 100% of the anal incontinence patients without significant sphincteric lesions or rectal prolapse. However, the treatment is expensive and can have side effects. Moreover, about 20 to 30% of the patients can develop a resistance to the SNS only a few months following the definite implantation. Yet the development of the posterior tibial nerve stimulation (PNTS) offers a new perspective. It consists in stimulating the same metameric area as the sacral nerves. It is regularly used for the treatment of urinary incontinence caused by overactive bladder. It is a non-invasive technique, causing but a few side effects. A preliminary study showed that 7 in 10 incontinent patients saw an improvement when treated with PTNS.

Purpose:

The aim of this study is to analyse and evaluate the PTNS technique in the short term as a treatment of anal incontinence. It is done through the means of a multi-centric prospective randomized study.

Patients:

Will be included: all patients followed for anal incontinence (either with liquid or solid stools) having at least one accident a month for 3months, and who are not diagnosed with colorectal lesions and who are without anal or rectal significant anatomic anomalies, without rectal prolapse, and who have failed to respond to medical treatment (such as medicine or perineal reeducation). The main criterium to analyze the efficiency will be the number of fecal incontinence episodes on a bowel diary. The investigators aim to incorporate 144 patients, that is 72 in each group. 12 centers will take part in this study, that will last 2 years and 3 months. They are the centers of: Bordeaux, Clermont-Ferrand, Grenoble, Lyon, Marseille, Nancy, Nantes, Paris, Diaconesses-Croix,Paris Rothschild, Rennes, Rouen, and Toulouse.

Method:

The PTNS consists in setting two electrodes on the posterial tibial nerve pathway. The electrodes are connected to an external stimulator. After having drawn lots, patients will be treated for 3months either with effective stimulation (frequency: 14hz; impulse duration: 210usec;intensity:sensibility threshold), or with shame stimulation (intensity: 0mAmp). There will be two daily sessions of stimulation (effective, or shame), 20 min each. A pre-treatment assessment will be established, composed of a stool diary, a Cleveland Clinic score, a Fecal Incontinence Quality of Life scale and an anorectal manomety, that will all be repeated by the end of the treatment.

Expected Results:

The investigators hope to prove the short term efficacy of the PTNS on anal incontinence patients.


Condition Intervention Phase
Fecal Incontinence
Procedure: active stimulation
Procedure: sham stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Short Term Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence:Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • fecal incontinence episode per week [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cleveland clinic score FIQL score analogic visual scale urinary score and anorectal manometry [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: October 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active stimulation
Percutaneous posterior tibial nerve stimulation
Procedure: active stimulation
percutaneous posterior tibial nerve stimulation with following parameters: frequency: 14hz; impulse duration: 210usec;intensity:sensibility threshold during 3 months
Sham Comparator: sham stimulation
Inefficient percutaneous posterior tibial nerve stimulation
Procedure: sham stimulation
Same location with the same device than active stimulation but amplitude of stimulation = 0

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • fecal incontinence, refractory to medical treatment,for more than 3 months,with at least one episode of anal incontinence and/or urgency per month
  • patient with no knowledge of cutaneous stimulation
  • patients with NHS

Exclusion Criteria:

  • older than 18 years old
  • pregnancy
  • implanted stimulator
  • cutaneous lesion
  • cutaneous anesthesia
  • patients without oral contraception
  • Guardianship and curatorship
  • fecal incontinence secondary to anorectal malformation, surgical sequelae, significative sphincteric lesion leading to repair at a first time, rectal prolapse, active neurological disease
  • patient already treated by sacral nerve stimulation or stimulated graciloplasty, artificial bowel sphincter, radiofrequency
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00977652

Locations
France
Leroi
Rouen, France, 76000
Sponsors and Collaborators
University Hospital, Rouen
Ministry of Health, France
  More Information

No publications provided

Responsible Party: Anne Marie LEROI, Head of the department, University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00977652     History of Changes
Other Study ID Numbers: 2008/070/HP, CPP-2008/032, RCB-2008-A01227-48
Study First Received: September 15, 2009
Last Updated: August 22, 2011
Health Authority: France: Institutional Ethical Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
fecal incontinence

Additional relevant MeSH terms:
Fecal Incontinence
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 29, 2014