TENS for faecal incontinence.

Transcutaneous electrical nerve stimulation (TENS) to enhance the anal tone in patients with faecal incontinence.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000321549

Enrollment

Registered

2006-07-26

Start date

2006-10-01

Completion date

Unknown

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

TENS is a therapeutic non-invasive modality mainly used for pain relief by electrically stimulating nerves via skin surface electrodes. TENS with electrodes over the lower back have also been used successfully to treat the overactive bladder to improve frequency and urgency of urination in patients. The association of treatment for faecal incontinence and urinary incontinence is evident in Sacral Nerve Stimulation (SNS). Based on clinical observation of effect of stimulation on the function of the anus and rectum in urology patients, SNS has been applied in patients with faecal incontinence. The concept is to enhance the activity of the anal muscles via the electrical stimulation of their nerve supply. The usefulness of SNS in faecal incontinence has been confirmed in a number of studies. However, SNS is an invasive procedure. It requires surgery under general anaesthesia to implant a permanent impulse generator under the skin. TENS with electrodes stimulating the same sacral nerves may result in similar benefits. Our hypothesis is that the use of TENS in patients with faecal incontinence may have a therapeutic effect. The advantage of this technique is that it is non-invasive, simple, and cost-effective and has minimal side effects.

Interventions

ranscutaneous electrical nerve stimulation (TENS) - treatment will involve electrodes placed over the lower back for two hours daily, for three months.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

20 Years to 90 Years

Healthy volunteers

Inclusion criteria

Signed informed consent; Wexner Score >10; Intact anal sphincters; Neurogenic Incontinence; Failed medical therapy; Compliant with questionnaires and attendance at clinics.

Exclusion criteria

Congenital anorectal malformations; Rectal surgery done <12 months ago (<24 months for cancer); Present external rectal prolapse; Chronic bowel diseases (e.g. IBD); Chronic diarrhoea, unmanageable by diet or drugs; Neurological diseases (e.g. diabetic neuropathy, multiple sclerosis or Parkinson’s disease); Pregnancy; Anatomical limitations preventing placement of an electrode; Skin disease risking infection (e.g. pyoderma, pilonidal sinus); Psychiatric or physical inability to comply with the study protocol; Patients with a poor understanding of English.

Outcome results