Sacral Nerve Stimulation for Faecal Incontinence - Placebo or Clinical Effective

Fecal Incontinence Clinical Trial

— SNS  

Official title:

Sacral Nerve Stimulation for Faecal Incontinence - Placebo or Clinical Effective: A Randomized Blinded Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03261622
• Other study ID #: 005
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: November 1, 2020

Study information

• Verified date: October 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Faecal Incontinence
• Fecal Incontinence

Intervention

Device:
• Sacral nerve stimulation at different stimulation amplitudes
Exploring the effect of different stimulation amplitude in a randomized study

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Hvidovre University Hospital, University of Tromso

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel Habit Diary changes	Change in number of incontinence episodes(Bowel Habit diary - =50% reduction in fecal incontinence episodes), compared to baseline.	12 weeks
Primary	Bowel Habit Diary changes	Change in number of incontinence episodes(Bowel Habit diary - =50% reduction in fecal incontinence episodes), compared to baseline.	4 weeks
Secondary	Bowel Habit Diary	Change in number of incontinence episodes(Bowel Habit diary - =50% reduction in fecal incontinence episodes), compared to baseline.	24 weeks
Secondary	Functional outcome measure - Wexner Incontinence score	Changes in Wexner incontinence score, compared to baseline.	4, 8, 12, and 24 weeks
Secondary	Functional outcome measure - St. Marks incontinence score	Changes in St. Marks incontinence score, compared to baseline.	4, 8, 12, and 24 weeks
Secondary	Quality of Life FI - specific	Changes in Rockwood Faecal Incontinence Quality of Life score, compared to baseline	4, 8, 12, and 24 weeks
Secondary	Changes in functional outcome - Urin incontinence (UI).	ICIQ_UI Short form,	4, 8, 12, and 24 weeks
Secondary	Visual analogue score (VAS score): patients overall satisfaction	VAS-score (0-100) for patients satisfaction with overall: Social function; Bowel function; Quality of life Baseline value used as reference	4, 8, 12, and 24 weeks
Secondary	Anal physiology test	Functional Lumen Imaging Probe (endoFLIP) and anal sensibility. The endoFLIP allows dynamic examination of the geometry and segmental distensibility properties of the anal canal by simultaneous measurement of anal pressure(PSI) and luminal cross sectional areas (CSAs) at 16 points along the length of the anal canal	baseline, 4,8,12 and 25 weeks after implantation(Only in patients implanted in Aarhus, Denmark)