Clinical trial NCT03261622: Sacral Nerve Stimulation for Faecal Incontinence - Placebo or Clinical Effective
Official title: Sacral Nerve Stimulation for Faecal Incontinence - Placebo or Clinical Effective: A Randomized Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Faecal Incontinence
Fecal Incontinence
Keywords: Sacral Nerve Stimulation
Sacral Nerve Modulation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Tromso
name: Hvidovre University Hospital
First posted: 2017-08-25
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to either control group (Stimulation amplitude at 90% of sensory threshold) or intervention arm (different stimulation amplitude - 0.05 V, 50 and 90% of sensory threshold)
Primary purpose: BASIC_SCIENCE

Brief summary: Sacral nerve stimulation (SNS) has over the last 20 years been recognised as an efficient treatment option for faecal incontinence (FI).

In a selected patient group we have evidence that 90% of patients will have a successful test period (≥50% reduction in incontinence episodes). If preoperative there is motor response on at least 3 out of 4 poles on the lead, at a threshold ≤1.5 mAMP.

Hypotheses In a selected patient group suffering from faecal incontinence a one-stage permanent implant will be possible. The functional results will be improved as more time can be spent finding the optimal pacemaker settings as the risk of infection is reduced compared to the stage implant. One-Stage implantation gives the opportunity to test the amount of placebo effect with SNS.

During the first 3 months postoperative patients will be randomized to either stimulation amplitude set at 90% of sensory threshold (control group) or 3 periods of stimulation at 0.05v (placebo), 50% and 90% of sensory threshold. Patients are randomized in a 1 to 2 pattern. After the initial 3 months the stimulation amplitude is increased to sensory threshold. After six months the project ends and the number of patients achieving the 50% improvement in incontinence episodes are evaluated.

Detailed description: Sacral nerve stimulation (SNS) has over the last 20 years been recognised as an efficient treatment option for faecal incontinence (FI). The therapy is recommended by the International Continence Society (ICS) if conservative treatments such as; regulation of diet and fibre supplements, medication, biofeedback therapy, glycerol suppositories, mini enema or transanal irrigation have been insufficient to improve continence to a satisfactory level.

The SNS therapy has traditionally been applied as a two step procedure. Firstly, a 3-4 week test-period, often with a permanent electrode with tines, followed by permanent implantation if at least a 50% symptom reduction has been obtained during the test stimulation.

In a selected patient group(idiopathic faecal incontinence or incontinence as a result of an external anal sphincter tear (\<160 degrees)) we have evidence that 90% of patients will have a successful test period (≥50% reduction in incontinence episodes). If preoperative there is motor response on at least 3 out of 4 poles on the lead, at a threshold ≤1.5 mAMP(unpublished data, submitted for publication) .

Thus, only 10% of the patients have the lead explanted after 3 to 4 weeks. In 90% of the patients a pacemaker is implanted after the test period, these patients will have an additional operation that could have been avoided if they had the permanent pacemaker implanted at the first stage.

Hypotheses In a selected patient group suffering from faecal incontinence a one-stage permanent implant will be possible. The functional results will be improved as more time can be spent finding the optimal pacemaker settings as the risk of infection is reduced compared to the stage implant. One-Stage implantation gives the opportunity to test the amount of placebo effect with SNS.

During the first 3 months postoperative patients will be randomized to either stimulation amplitude set at 90% of sensory threshold (control group) or 3 periods of stimulation at 0.05v (placebo), 50% and 90% of sensory threshold. Patients are randomized. After the initial 3 months the stimulation amplitude is increased to sensory threshold. After six months the project ends and the number of patients achieving the 50% improvement in incontinence episodes are evaluated.

Eligibility criteria: Inclusion Criteria:

* ≥18 years
* Informed consent
* Idiopathic faecal incontinence or incontinence following external sphincter tear ≤ 160 degrees.
* ≥ one faecal incontinence episode after optimized conservative treatment.
* Ability to use the patient programmer.

Exclusion Criteria:

* Pregnancy
* Diabetes
* Neurological diseases, including spinal cord injuries
* Pelvic irradiation
* Rectal resections

Primary outcomes:
measure: Bowel Habit Diary changes
timeFrame: 12 weeks
measure: Bowel Habit Diary changes
timeFrame: 4 weeks
Secondary outcomes:
measure: Bowel Habit Diary
timeFrame: 24 weeks
measure: Functional outcome measure - Wexner Incontinence score
timeFrame: 4, 8, 12, and 24 weeks
measure: Functional outcome measure - St. Marks incontinence score
timeFrame: 4, 8, 12, and 24 weeks
measure: Quality of Life FI - specific
timeFrame: 4, 8, 12, and 24 weeks
measure: Changes in functional outcome - Urin incontinence (UI).
timeFrame: 4, 8, 12, and 24 weeks
measure: Visual analogue score (VAS score): patients overall satisfaction
timeFrame: 4, 8, 12, and 24 weeks
measure: Anal physiology test
timeFrame: baseline, 4,8,12 and 25 weeks after implantation(Only in patients implanted in Aarhus, Denmark)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
state: Aarhus C
Study officials:
affiliation: Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
name: Jakob K. Jakobsen, MD. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: