Improving the Efficacy of Sacral Nerve Stimulation for Fecal Incontinence by Alteration of Stimulation Parameters

Fecal Incontinence Clinical Trial

Official title:

Improving the Efficacy of Sacral Nerve Stimulation for Fecal Incontinence by Alteration of Stimulation Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254695
• Other study ID #: 004
• Status: Completed
• Phase: N/A
• First received: December 3, 2010
• Last updated: November 9, 2011
• Start date: July 2010
• Est. completion date: June 2011

Study information

• Verified date: November 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research EthicsUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Faecal incontinence is a devastating condition affecting 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated. Sacral nerve stimulation (SNS), has over the last decade given hope to patient failing conservative treatment. Some patient do not have optimal continence after SNS-therapy. This study aims to identify optimal stimulation parameters - that will improve the functional outcome of SNS-therapy thru a double blinded randomized cross-over study.

Description:

Faecal incontinence is a devastating condition affecting daily living and has major influences on 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, SNS has over the last decade given new hope to these patients. But a group of these patients has minor effect of the treatment - despite a satisfactory test-stimulation period. This study aims to identify optimal stimulation parameters that will improve patient continence and quality of life. Four different stimulation parameters will be tested through a double blind, randomized crossover study - standard stimulation parameters (frequency: 14 Hz, pulse width 210 microsec.) will serve as control stimulation.

The study includes five arms that will be tested in a randomized order. Each arm will be tested for four weeks in which the patient fill in bowel habit diaries and standardized questionnaires. The first week in each period will not be evaluated - is serves as a wash-out period.

Before any pacemaker changes anorectal manometry and rectal filling tests will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed Consent

• Diagnosed with idiopathic faecal incontinence,incontinence with minor (=60 degrees) sphincteric defects or incontinence following sphincter repair.

• Medtronic Interstim IPG(pacemaker)implanted for more than 6 months

• minimum one incontinence episodes pr. week during ongoing SNS-therapy

Exclusion Criteria:

• Colorectal surgery after IPG-implantation

• Pregnancy or breastfeeding

• Anal/perianal pain or discomfort

• 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, coeliac, neurological disorders.

• Spinal cord injury

• Irritable Bowel Syndrome

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Device:
• Medtronic InterStim / InterStim II
Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4

Locations

Country	Name	City	State
Denmark	Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital	Aarhus	Aarhus C
United Kingdom	St. Marks Hospital	London	Harrow - Middlesex

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	London North West Healthcare NHS Trust

Countries where clinical trial is conducted

Denmark,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life changes	Quality of life will be recorded by means of Rockwood faecal incontinence quality of life score. A total of five evaluations will be made every fourth week in the twenty week protocol perioed.	Will be assessed every four weeks during a twenty-week period	No
Secondary	Number of incontinence episodes	Assess number of incontinence episodes, by means of bowel habit diary. Four week bowel habit diary will be evaluated five times during the twenty-week protocol perioed.	Will be assessed every four weeks durring a twenty-week period	No
Secondary	Days with faecal soiling	By means of a four week bowel habit diary	Will be assessed every four weeks during a twenty-week period	No
Secondary	Days with faecal urgency.	By means of a four week bowel habit diary	Will be assessed every four weeks during a twelve-week period	No
Secondary	Wexner incontinence score		Will be assessed every four weeks during a twenty-week period	No
Secondary	St. Marks Incontinence score		Will be assessed every four weeks during a twenty-week period	No
Secondary	Assess changes in anorectal volume and pressure with different pacemaker settings	Resting, maximal anal sphincter pressure and rectal filling(first sensation, urge to defacate and maximal tolerabel volume(Air))pressure will be measured with different pacemaker settings. In total five evaluations will be made in the twenty week protocol perioed.	Will be assessed every four weeks during a twenty-week period	No