Treatment of Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Stimulation Bilaterally?

NCT00913601 | Terminated DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fecal Incontinence

Keywords

Idiopathic Fecal Incontinence; Fecal Incontinence; Sacral Nerve Stimulation; Sacral Nerve Neuromodulation

Outcome Measures

Primary Outcomes (1)

• Number of faecal incontinence episodes per week.

  1, 2, and 3 months after enrolment to the project

Secondary Outcomes (5)

• Days with faecal soiling.

  1, 2, and 3 months after enrolment to the project

• Days with faecal urgency.

  1, 2, and 3 months after enrolment to the project

• Wexner incontinence score.

  1, 2, and 3 months after enrolment to the project

• Anal physiological changes during SNS bilateral versus unilateral.

  1, 2, and 3 months after enrolment to the project

• Quality of life assessment (Rockwood - Fecal incontinence quality of life)

  1, 2, and 3 months after enrolment to the project

Study Arms (3)

Dextra

EXPERIMENTAL

Unilateral sacral nerve stimulation dextra for 4 weeks

Device: Medtronic INTERSIM II - 3058

Sinistra

EXPERIMENTAL

Unilateral sacral nerve stimulation sinistra 4 weeks

Device: Medtronic INTERSIM II - 3058

Bilateral

EXPERIMENTAL

Bilateral sacral nerve stimulation 4 weeks

Device: Medtronic INTERSIM II - 3058

Interventions

Medtronic INTERSIM II - 3058 DEVICE

Medtronic INTERSIM II - 3058 Impuls Generator

Also known as: Impuls Generator

Bilateral; Dextra; Sinistra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent
• Diagnosed with idiopathic faecal incontinence and planned sacral nerve stimulation
• Age\> 40 years normal sigmoid/colonoscopic prior to operation

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• MEDTRONIC DANMARK A/S Arne Jacobsens Alle 17 DK-2300 København S Danmark: collaborator

Study Sites (1)

Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital

Aarhus, Aarhus C, 8000, Denmark

Location

Related Publications (5)

• 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. doi: 10.1016/s0140-6736(95)91799-3.

  PMID: 7475602 BACKGROUND

• 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. doi: 10.1136/gut.44.3.407.

  PMID: 10026329 BACKGROUND

• Rasmussen OO, Christiansen J. [Sacral nerve stimulation in fecal incontinence]. Ugeskr Laeger. 2002 Aug 12;164(33):3866-8. Danish.

  PMID: 12216156 BACKGROUND

• 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. doi: 10.1002/bjs.4796.

  PMID: 15455360 BACKGROUND

• 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. doi: 10.1007/s10350-006-0548-8.

  PMID: 16721520 BACKGROUND

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jakob K Jakobsen, MD

  Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 4, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 3, 2014

Record last verified: 2014-07

Locations

DK (1)