Dose Response Curve - Sacral Nerve Stimulation for Faecal Incontinence
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|ClinicalTrials.gov Identifier: NCT01130870|
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : November 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence||Device: Sensory Threshold Device: 75% of sensory threshold - Amplitude Device: 50% of sensory threshold - Amplitude||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Dose Response Curve - Sacral Nerve Stimulation for Faecal Incontinence|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||June 2011|
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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130870
|Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital|
|Aarhus, Aarhus C, Denmark, 8000|