Fecal Incontinence Clinical Trial
— SNSOfficial title:
Treatment of Idiopathic Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Implantation and Stimulation of Permanent Electrodes Bilaterally - a Double-blinded Randomized Cross-over Trial
Faecal incontinence is a devastating condition causing psychological stress, affecting daily living and influences quality of life. Faecal incontinence affects 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated, because most patients don't discuss this affliction with their general practitioner. A new treatment, sacral nerve stimulation (SNS), has over the last decade given hope to these patients. The treatment is divided in two; first a test operation (PNE-test) has to reveal if the patient will benefit from treatment with permanent sacral nerve stimulation. Second if the patient benefit from the PNE-test, they proceed to final implant. 75-80% of the patients with idiopathic fecal incontinence benefit from the PNE-test, 70% of those get satisfactory functional results and the remaining 30% get suboptimal improvement in continence after permanent unilateral sacral nerve stimulation. The aim of this project is to investigate if bilateral sacral nerve stimulation can produce better fecal continence results than standard unilateral stimulation, through a double blind, randomized crossover study.
Status | Terminated |
Enrollment | 29 |
Est. completion date | July 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Informed Consent - Diagnosed with idiopathic faecal incontinence and planned sacral nerve stimulation - Age> 40 years normal sigmoid/colonoscopic prior to operation Exclusion Criteria: - Pregnant or breastfeeding - Patients who are not deemed able to follow the planned testing program, including mental illness or mentally unstable patients - Medication with known effects on gastrointestinal motility, thyroid disease, diabetes, coeliaki, neurological disorders. - Irritable Bowel Syndrome |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital | Aarhus | Aarhus C |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | MEDTRONIC DANMARK A/S Arne Jacobsens Alle 17 DK-2300 København S Danmark |
Denmark,
Jarrett ME, Mowatt G, Glazener CM, Fraser C, Nicholls RJ, Grant AM, Kamm MA. Systematic review of sacral nerve stimulation for faecal incontinence and constipation. Br J Surg. 2004 Dec;91(12):1559-69. Review. — View Citation
Matzel KE, Stadelmaier U, Hohenfellner M, Gall FP. Electrical stimulation of sacral spinal nerves for treatment of faecal incontinence. Lancet. 1995 Oct 28;346(8983):1124-7. — View Citation
Michelsen HB, Buntzen S, Krogh K, Laurberg S. Rectal volume tolerability and anal pressures in patients with fecal incontinence treated with sacral nerve stimulation. Dis Colon Rectum. 2006 Jul;49(7):1039-44. — View Citation
Rasmussen OØ, Christiansen J. [Sacral nerve stimulation in fecal incontinence]. Ugeskr Laeger. 2002 Aug 12;164(33):3866-8. Danish. — View Citation
Vaizey CJ, Kamm MA, Turner IC, Nicholls RJ, Woloszko J. Effects of short term sacral nerve stimulation on anal and rectal function in patients with anal incontinence. Gut. 1999 Mar;44(3):407-12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of faecal incontinence episodes per week. | 1, 2, and 3 months after enrolment to the project | No | |
Secondary | Days with faecal soiling. | 1, 2, and 3 months after enrolment to the project | No | |
Secondary | Days with faecal urgency. | 1, 2, and 3 months after enrolment to the project | No | |
Secondary | Wexner incontinence score. | 1, 2, and 3 months after enrolment to the project | No | |
Secondary | Anal physiological changes during SNS bilateral versus unilateral. | 1, 2, and 3 months after enrolment to the project | No | |
Secondary | Quality of life assessment (Rockwood - Fecal incontinence quality of life) | 1, 2, and 3 months after enrolment to the project | No |
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