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Clinical and Physiological Impact of Interrupting Sacral Neuromodulation Therapy in Patients with Faecal Incontinence

A Double-Blind Randomised Crossover Trial to Determine the Clinical and Physiological Impact of Temporarily Interrupting Sacral Neuromodulation in Patients with Faecal Incontinence

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000786594
Enrollment
18
Registered
2015-07-29
Start date
2014-08-20
Completion date
2015-04-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Sacral Neuromodulation or SNM is a well-established treatment for bowel leakage, also known as faecal incontinence. It uses a small device (a stimulator) that is implanted under the skin in the upper buttock area. It then transmits electrical pulses through a small wire that is positioned close to the sacral nerve to improve bowel control and function. Despite being very successful for the treatment of faecal incontinence, the exact mechanism by which it works remains unknown. It is possible that SNM influences the way that the brain and gut interact by ‘resetting’ its function back to normal, a bit like restarting a computer after it ‘crashes’. If this is true, long-term SNM may not be necessary to control symptoms. The aim of this study is to assess the impact of SNM on bowel symptoms and bowel control, particularly when SNM is switched off. The group studied will include patients with faecal incontinence who have successfully been stimulated for at least 6 months. A total of 20 patients will be recruited and randomised into two groups; each group will have two cycles of different exposure. Each cycle will last for 6 weeks and will involve either turning the stimulator Off or On. Patients and assessors will be unaware whether the stimulator is On or Off, so as to reduce the effect of bias. At each 6-week cycle, all patients recruited will attend the hospital to adjust their stimulator and to complete a questionnaire and undergo physiology tests to measure bowel control and function. At the end of the study the SNM will be switched back to the original setting. Study outcomes will involve assessment of bowel symptoms, severity of faecal incontinence, quality of life scores and anorectal physiological function. This study will provide important information in understanding and treating disorders of bowel function and bowel leakage.

Interventions

The intervention is to switch off the neuromodulation device which is the implanted pulse generator that stimulates the sacral nerve. The device is switched off for 6 weeks by a nurse. To monitor adherence to the intervention the remote control which the patient usually uses to turn their device off or on is placed in a security sealed envelope. Each cycle includes 2 weeks of washout period.

Sponsors

Professor Marc A Gladman
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age >18 years 2. Predominant symptom: faecal Incontinence 3. Have been implanted with a permanent sacral nerve stimulator for at least 6 months 4. Subjective improvement in symptoms of faecal incontinence compared to baseline (i.e prior to the implantation of the stimulation device)

Exclusion criteria

1. Non-English speaking 2. Cognitive impairment 3. Non-ambulatory 4. Pregnancy 5. Neurological disorders e.g. Spina Bifida or Multiple Sclerosis

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026