Sacral Nerve Stimulation for Faecal Incontinence - Placebo or Clinical Effective

NCT03261622 | Completed

• 1 other identifier: 005
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Faecal Incontinence; Fecal Incontinence

Keywords

Sacral Nerve Stimulation; Sacral Nerve Modulation

Outcome Measures

Primary Outcomes (2)

• Bowel Habit Diary changes

  Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline.

  12 weeks

• 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 Outcomes (7)

• Bowel Habit Diary

  24 weeks

• Functional outcome measure - Wexner Incontinence score

  4, 8, 12, and 24 weeks

• Functional outcome measure - St. Marks incontinence score

  4, 8, 12, and 24 weeks

• Quality of Life FI - specific

  4, 8, 12, and 24 weeks

• Changes in functional outcome - Urin incontinence (UI).

  4, 8, 12, and 24 weeks

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Stimulation amplitude at 90% of sensory threshold during period 1 to 3. (each period 4 weeks)

Device: Sacral nerve stimulation at different stimulation amplitudes

Intervention arm

SHAM COMPARATOR

Alternation of stimulation amplitude 1. Period - Stimulation amplitude 0.05 Volts (lowest possible) 2. Period - Stimulation amplitude - 50% of sensory threshold. 3. Period - Stimulation amplitude - 90% of sensory threshold.

Device: Sacral nerve stimulation at different stimulation amplitudes

Interventions

Sacral nerve stimulation at different stimulation amplitudes DEVICE

Exploring the effect of different stimulation amplitude in a randomized study

Control arm; Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• University of Tromso: collaborator
• Hvidovre University Hospital: collaborator

Study Sites (1)

Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital

Aarhus, Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Encopresis; Fecal Incontinence

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jakob K. Jakobsen, MD. Ph.D.

  Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Alle patients are stimulated sub-sensory in (3x4 weeks) and will be blinded. The investigators will not participate in the randomization, and setting of the stimulation amplitude.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (M.D. Ph.D.)

Model Details: 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)

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: August 25, 2017
• Study Start: November 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2020
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)