Track topics on Twitter Track topics that are important to you
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.
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.
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.
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.
The investigators hope to prove the short term efficacy of the PTNS on anal incontinence patients.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
active stimulation, sham stimulation
Not yet recruiting
University Hospital, Rouen
Published on BioPortfolio: 2014-08-27T03:19:19-0400
The aim of this study is to assess feasibility, acceptability and efficacy of two VRET (Virtual Reality Exposition Therapy)session associated with either active anodal tDCS or sham tDCS on...
In this study the investigators aim to investigate the effects of two different types of non-invasive brain stimulation techniques -- repetitive transcranial magnetic stimulation (rTMS) an...
This study explores the effects of mirror therapy and transcranial Direct Current Stimulation (tDCS, Soterix ©) in a randomized factorial controlled trial in which patients will be assign...
In a double-blinded, randomized, parallel controlled design, patients with schizophrenia spectrum disorder will be exposed to active or sham repetitive transcranial magentic stimulation (T...
This study will be comprised of two Phases. Phase 1 is a randomized, double-blinded study testing repetitive Transcranial Magnetic Stimulation (rTMS) versus sham (20 treatments over 4 week...
Transcranial direct current stimulation (tDCS) has emerged as a promising new treatment for major depression. While recent randomised, sham-controlled studies found tDCS to have antidepressant effects...
Transcutaneous vagus nerve stimulation (TVNS) is a promising treatment for acute and chronic pain. However, experimental studies yielded controversial results. We examined if TVNS reduces the perceive...
The interference effects of transcranial magnetic stimulation (TMS) on several electroencephalographic (EEG) measures in both temporal and frequency domains have been reported. We tested the hypothesi...
Median Nerve Stimulation (MNS) has been shown to change brain metaplasticity over the somatosensory networks, based on a bottom-up mechanism and may improve motor learning. This exploratory study aime...
Brain stimulation modulates the excitability of neural circuits and drives neuroplasticity. While the local effects of stimulation have been an active area of investigation, the effects on large-scale...
Stimulation of the brain, which is self-administered. The stimulation may result in negative or positive reinforcement.
Stimulation at an intensity below that where a differentiated response can be elicited.
The electrical response evoked in a muscle or motor nerve by electrical or magnetic stimulation. Common methods of stimulation are by transcranial electrical and TRANSCRANIAL MAGNETIC STIMULATION. It is often used for monitoring during neurosurgery.
Abnormal descent of a pelvic organ resulting in the protrusion of the organ beyond its normal anatomical confines. Symptoms often include vaginal discomfort, DYSPAREUNIA; URINARY STRESS INCONTINENCE; and FECAL INCONTINENCE.
A technique of brain electric stimulation therapy which uses constant, low current delivered via ELECTRODES placed on various locations on the scalp.
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...