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

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT01254695

Collaborator

London North West Healthcare NHS Trust (Other)

Enrollment

Locations

Arms

Duration (Months)

7.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fecal Incontinence	Device: Medtronic InterStim / InterStim II	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard settings Amplitude: Sensory threshold Frequency:14 Hz Pulse width 210 μsec	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 Other Names: Medtronic InterStim Medtronic InterStim II
Experimental: Experimental Setting 1 Amplitude: Sensory threshold Frequency:6.9 Hz Pulse width 210 μsec	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 Other Names: Medtronic InterStim Medtronic InterStim II
Experimental: Experimental setting 2 Amplitude: Sensory threshold Frequency:31 Hz Pulse width 210 μsec	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 Other Names: Medtronic InterStim Medtronic InterStim II
Experimental: Experimental setting 3 Amplitude: Sensory threshold Frequency:14 Hz Pulse width 330 μsec	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 Other Names: Medtronic InterStim Medtronic InterStim II
Experimental: Experimental setting 4 Amplitude: Sensory threshold Frequency:14 Hz Pulse width 90 μsec	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 Other Names: Medtronic InterStim Medtronic InterStim II

Outcome Measures

Primary Outcome Measures

Quality of life changes [Will be assessed every four weeks during a twenty-week period]
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.

Secondary Outcome Measures

Number of incontinence episodes [Will be assessed every four weeks durring a twenty-week period]
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.
Days with faecal soiling [Will be assessed every four weeks during a twenty-week period]
By means of a four week bowel habit diary
Days with faecal urgency. [Will be assessed every four weeks during a twelve-week period]
By means of a four week bowel habit diary
Wexner incontinence score [Will be assessed every four weeks during a twenty-week period]
St. Marks Incontinence score [Will be assessed every four weeks during a twenty-week period]
Assess changes in anorectal volume and pressure with different pacemaker settings [Will be assessed every four weeks during a twenty-week period]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital	Aarhus	Aarhus C	Denmark	8200
2	St. Marks Hospital	London	Harrow - Middlesex	United Kingdom	HA1 3UJ