Clinical trial NCT01130870: Dose Response Curve - Sacral Nerve Stimulation for Faecal Incontinence
Official title: Dose Response Curve - Sacral Nerve Stimulation for Faecal Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Keywords: Fecal incontinence
Sacral nerve stimulation
Quality of life
DR15.9 Incontinentia alva
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2010-05-26
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of incontinence episodes Assess number of incontinence episodes.
timeFrame: Will be assessed every four weeks during a twelve-week period
Secondary outcomes:
measure: Assess changes in anorectal volume and pressure with different amplitude.
timeFrame: Will be assessed every four weeks during a twelve-week period
measure: Assess Quality of life after decrease in stimulation amplitude.
timeFrame: Will be assessed every four weeks during a twelve-week period
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
state: Aarhus C
Study officials:
References:
citation: 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.