Dose Response Curve - Sacral Nerve Stimulation for Faecal Incontinence

Fecal Incontinence Clinical Trial

Official title:

Dose Response Curve - Sacral Nerve Stimulation for Faecal Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130870
• Other study ID #: 002
• Secondary ID: 002
• Status: Completed
• Phase: N/A
• First received: May 14, 2010
• Last updated: November 9, 2011
• Start date: April 2010
• Est. completion date: June 2011

Study information

• Verified date: November 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Device:
• Sensory Threshold
Sacral nerve stimulation with amplitude (sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.
• 75% of sensory threshold - Amplitude
Sacral nerve stimulation with amplitude (75% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.
• 50% of sensory threshold - Amplitude
Sacral nerve stimulation with amplitude (50% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.

Locations

Country	Name	City	State
Denmark	Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital	Aarhus	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of incontinence episodes Assess number of incontinence episodes.	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	No
Secondary	Assess changes in anorectal volume and pressure with different amplitude.	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	No
Secondary	Assess Quality of life after decrease in stimulation amplitude.	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	No