Dose Response Curve - Sacral Nerve Stimulation for Faecal Incontinence

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of Aarhus

ClinicalTrials.gov Identifier:

NCT01130870

First received: May 14, 2010

Last updated: November 9, 2011

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	May 14, 2010
Last Updated Date	November 9, 2011
Start Date ^ICMJE	April 2010
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 25, 2010)	Number of incontinence episodes Assess number of incontinence episodes. [ Time Frame: Will be assessed every four weeks during a twelve-week period ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01130870 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 25, 2010)	Assess changes in anorectal volume and pressure with different amplitude. [ Time Frame: Will be assessed every four weeks during a twelve-week period ] [ Designated as safety issue: No ] 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. Assess Quality of life after decrease in stimulation amplitude. [ Time Frame: Will be assessed every four weeks during a twelve-week period ] [ Designated as safety issue: No ] 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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Dose Response Curve - Sacral Nerve Stimulation for Faecal Incontinence
Official Title ^ICMJE	Dose Response Curve - Sacral Nerve Stimulation for Faecal Incontinence
Brief Summary	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.
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 ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Fecal Incontinence
Intervention ^ICMJE	Device: Sensory Threshold Sacral nerve stimulation with amplitude (sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec. Device: 75% of sensory threshold - Amplitude Sacral nerve stimulation with amplitude (75% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec. Device: 50% of sensory threshold - Amplitude Sacral nerve stimulation with amplitude (50% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.
Study Arm (s)	Active Comparator: Sensory threshold - Amplitude Stimulation amplitude set at sensory threshold. Intervention: Device: Sensory Threshold Experimental: 25% below sensory threshold - Amplitude Stimulation amplitude 75% of sensory threshold. Intervention: Device: 75% of sensory threshold - Amplitude Experimental: 50% below sensory threshold - Amplitude Stimulation with amplitude set 50% below sensory threshold Intervention: Device: 50% of sensory threshold - Amplitude
Publications *	Duelund-Jakobsen J, Buntzen S, Lundby L, Laurberg S. Sacral nerve stimulation at subsensory threshold does not compromise treatment efficacy: results from a randomized, blinded crossover study. Ann Surg. 2013 Feb;257(2):219-23. doi: 10.1097/SLA.0b013e318269d493.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	19
Completion Date	June 2011
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT01130870
Other Study ID Numbers ^ICMJE	002, 002
Has Data Monitoring Committee	Yes
Responsible Party	University of Aarhus
Study Sponsor ^ICMJE	University of Aarhus
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Aarhus
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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