Dose Response Curve - Sacral Nerve Stimulation for Faecal Incontinence

November 9, 2011 updated by: University of Aarhus
The purpose of this study is to determine if subsensory stimulation (amplitude) will maintain same continence in patients treated with Sacral Nerve Stimulation (SNS) for faecal incontinence as stimulation with amplitude at sensory threshold.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Faecal incontinence is a devastating condition with huge impact on quality of life. Sacral Nerve Stimulation (SNS) has since 1995 been a treatment option for patients not obtaining satisfactory continence result with standard non-surgical treatments. SNS is electrical stimulation of the sacral nerve root(s2,3 or 4). Stimulation of this nerve roots results in improved continence. The mechanism of action is at present not well described.

Standard the neuromodulator (pacemaker) stimulate with Frequency 14 Hz, pulse width 210 mic.sec. and amplitude set at sensory threshold. One study by SM. Koch et all confirms that subsensory stimulation can be effective. At present there is no doubled blinded study's to confirm this theory of effective sub sensory stimulation.

The aim of this study is to determine if subsensory stimulation will be as effective as stimulation with amplitude at sensory threshold. This will be investigated in 20 patients who have had at least a reduction in incontinence episodes or Wexner inc. score of 75 % between preimplantation and latest follow up. The patients will be randomized to three different amplitudes. 1: amplitude set at sensory threshold. 2: 75% of sensory threshold. 3: 50% of sensory threshold. The order of the three settings will be random and in a double blinded manner. The interval between these three pacemaker settings is four weeks. Patients serve as there own controls. Stimulation frequency (14 Hz) and pulse width (210 mic-sec) will remain fixed.

Evaluation will be by means of 4 week bowel habit diary and questionnaires (Wexner inc. score / St. Marks Score / Wexner constipation score / Altomares OD-score / IBS-score/ Rockwood FIQoL -score). All patients will be evaluated with anorectal measurements (sphincter strength and anorectal volume measurements) before any changes of stimulation amplitude.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Aarhus C
      • Aarhus, Aarhus C, Denmark, 8000
        • Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • Informed consent
  • Idiopathic fecal incontinence or Fecal incontinence due to small sphincter defect(≤60 o)
  • fecal incontinence after primary/secondary sphincter repair
  • Permanent neuromodulator (medtronic InterStim / Interstim II) implanted for at least 12 weeks before entering the study.
  • Reduction in fecal incontinence episodes of at least 75% between baseline and latest follow up.(Bowel diary card) or 75% reduction of Wexner Inc. score.
  • Willing and competent to fill out diary cards

Exclusion Criteria:

  • Colorectal/proctological surgery since IPG-implant
  • Pregnancy
  • Anorectal Pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sensory threshold - Amplitude
Stimulation amplitude set at sensory threshold.
Device: Sensory Threshold
Sacral nerve stimulation with amplitude (sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.
Experimental: 25% below sensory threshold - Amplitude
Stimulation amplitude 75% of sensory threshold.
Device: 75% of sensory threshold - Amplitude
Sacral nerve stimulation with amplitude (75% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.
Experimental: 50% below sensory threshold - Amplitude
Stimulation with amplitude set 50% below sensory threshold
Device: 50% of sensory threshold - Amplitude
Sacral nerve stimulation with amplitude (50% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of incontinence episodes Assess number of incontinence episodes.
Time Frame: Will be assessed every four weeks during a twelve-week period
Assess number of incontinence episodes, by means of bowel habit diary. Four week bowel habit diary will be evaluated three times during the twelve-week protocol perioed.
Will be assessed every four weeks during a twelve-week period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess changes in anorectal volume and pressure with different amplitude.
Time Frame: Will be assessed every four weeks during a twelve-week period
Resting and maximal anal sphincter pressure will be measured with different amplitude settings. In total three evaluations will be made in the twelve week protocol perioed.
Will be assessed every four weeks during a twelve-week period
Assess Quality of life after decrease in stimulation amplitude.
Time Frame: Will be assessed every four weeks during a twelve-week period
Quality of life will be recorded by means of Rockwood faecal incontinence quality of life score. A total of three evaluations will be made every fourth week in the twelve week protocol perioed.
Will be assessed every four weeks during a twelve-week period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 14, 2010

First Submitted That Met QC Criteria

May 25, 2010

First Posted (Estimate)

May 26, 2010

Study Record Updates

Last Update Posted (Estimate)

November 10, 2011

Last Update Submitted That Met QC Criteria

November 9, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002 (University of CT Health Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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