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Completed

NCT Number: NCT02349334

UK Trial of Percutaneous Tibial Nerve Stimulation in Patients With Faecal Incontinence

Faecal incontinence occurs when a person passes faeces (stools) without the usual control. It is a distressing condition that is actually very common although under-reported because of embarrassment. Milder symptoms may be managed by treatments such as dietary change, drugs and bowel retraining, but many patients still resort to surgery to improve symptoms. Although several operations exist to treat incontinence e.g. those aiming to repair damaged anal sphincter muscles, it is now clear that these often have poor results.

Two relatively new treatments called sacral nerve stimulation (SNS) and percutaneous tibial nerve stimulation (PTNS) involve sending pulses of electricity to the nerves controlling the bowel and muscles of the anus (anal sphincter).

SNS does this by inserting electrodes in the lower back just above the tailbone and connecting them to an implanted electrical stimulator which is buried in the buttock and acts a bit like a heart pacemaker. SNS is a relatively well-established treatment in specialist centres, which has been used for over 10 years. It has been shown in studies to be successful for faecal incontinence achieving some improvement in at least three quarters of patients. In Europe, this procedure is fast becoming first treatment offered when non-surgical treatments fail. Nevertheless, SNS is not a miracle cure for all, requiring 2 operations, with potential complications and expensive equipment (> £10,000 approx).

PTNS is a newer treatment, which involves electrically stimulating a nerve at the ankle, using a very small needle, as an outpatient (a bit like acupuncture). This sends signals back to the spine region to try and improve symptoms of faecal incontinence. Since this is a newer treatment, fewer studies have been performed to quantify how successful it is, but early results of PTNS suggest that it may be as good as SNS. If this is true, this is very important because it is much less invasive and considerably cheaper than SNS (equipment £500 per patient).

This project will for the first time determine how effective PTNS is in the treatment of patients with faecal incontinence, by comparing it to sham (fake stimulation). This study is a properly designed clinical trial of 212 patients in at least 14 UK Specialist Centres.. The results of this trial will lead to direct benefits for patients and the NHS.

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Key information

Conditions

Faecal Incontinence Behavior Behavioral Symptoms Bowel Incontinence Digestive System Diseases Elimination Disorders Encopresis Fecal Incontinence Gastrointestinal Diseases Intestinal Diseases Mental Disorders Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Faecal incontinence sufficiently severe enough to warrant intervention
  • Failure of appropriate conservative therapies
  • Age ≥ 18 years

Exclusion criteria

  • Inability to provide informed consent for the research study
  • Inability to fill in the detailed bowel diaries required for outcome assessments (this will exclude participants who do not speak / read English)*
  • Neurological diseases, such as diabetic neuropathy, multiple sclerosis and Parkinson's disease (any participant with painful peripheral neuropathy)
  • Anatomical limitations that would prevent successful placement of needle electrode
  • Other medical conditions precluding stimulation: e.g. bleeding disorders, certain cardiac pacemakers, peripheral vascular disease or ulcer, lower leg cellulitis
  • Congenital anorectal anomalies or absence of native rectum due to surgery
  • A cloacal defect
  • Present evidence of external full thickness rectal prolapse
  • Previous rectal surgery (rectopexy / resection) done < 12 months ago (24 months for cancer),
  • Stoma in situ
  • Chronic bowel diseases such as inflammatory bowel disease leading to chronic uncontrolled diarrhoea
  • Pregnancy or intention to become pregnant
  • Previous experience of SNS or PTNS

Treatment and study plan

Percutaneous Tibial Nerve Stimulation

Device

Primary outcomes

  1. Primary outcome: Binary - success or failure based on % patients achieving > or = 50% reduction in faecal incontinence episodes

    Time frame: 3 months

    From 2 weekly bowel diaries before and after treatment

Secondary outcomes

  1. Reduction in faecal incontinence episodes

    Time frame: 3 months

  2. Proportion of patients achieving >25%, >75% and 100% reduction in faecal incotinence episodes

    Time frame: 3 months

  3. Reduction in Cleveland Clinic Constipation Score

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study title

CONtrol of Faecal Incontinence Using Distal NeuromodulaTion (CONFIDeNT)

Acronym: CONFIDeNT

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 28, 2015
Registry last updated
Jan 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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