Details of HTA project in progress
Last updated: 9 May 2012 - Next update due: 16 May 2012
Research type: |
Primary Research (e.g. trial) |
Project title: |
CONtrol of Faecal Incontinence using Distal NeuromodulaTion (CONFIDeNT) |
Project ref: |
09/104/16 |
Cost: |
£529,685 |
Chief Investigator : |
Mr Charles Henry Knowles, Clinical Prof of Surgical Research & Hon Consultan, Academic Surgical Unit, Barts and the London School of Medicine and Dentistry |
Project Website |
http://www.prnewswire.com/news-releases/english-releases/uroplasty-announces-enrollment-of-first-patients-in-the-confident-clinical-study-for-treatment-of-fecal-incontinence-with-urgent-pc-139388248.html |
Start Date: |
September 2011 |
Estimated date of publication in HTA journal series: |
Early 2015. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
Faecal incontinence occurs when a person passes faeces (stools) without the usual control. It is 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. In the last 10 years, SNS has been shown 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 per patient). PTNS is a simpler method in which a nerve is electrically stimulated under the skin by a very small needle above the ankle as an outpatient (a bit like acupuncture). This sends signals back to the spine region to try and achieve the same effect as SNS. 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). However, we dont know the true effectiveness of PTNS in the treatment of patients with faecal incontinence compared to sham (fake stimulation). We will determine this in a properly designed and already ethically-approved 3 month trial of 212 patients across 13 UK centres led by a registered clinical trial unit at Barts and the London which specialises in this sort of study. Further, we will study how well this treatment effect is maintained to one year follow up and the economic cost implications thereof. If, as we suspect, PTNS proves to be both effective and cost effective, the results of this study will impact greatly on how faecal incontinence is managed in the NHS with the potential for substantially reduced NHS resource utilisation in the future. |
Project Abstract: |
DESIGN: Pragmatic multi-centre, double-blinded, placebo-controlled trial of 212 patients randomized to receive the intervention (PTNS) or sham (needle insertion and electrical stimulation). All patients follow an assessment period, recruitment, allocation, standard 3 month treatment protocol (one 30 min session per week) with trial outcomes determined at 14 weeks. SETTING: 14 UK centres providing specialist nurse-led treatment for pelvic floor disorders. The fully registered Pragmatic Clinical Trials Unit at Barts and the London School of Medicine and Dentistry will be the coordinating CTU. TARGET POPULATION: Patients aged > 18 years with FI who have failed conservative treatments and whose symptoms are sufficiently severe to merit further intervention. HEALTH TECHNOLOGIES BEING ASSESSED: PTNS (Urgent PC) is produced by a single manufacturer (Uroplasty ®). The equipment includes a hand held pulse generator unit and single use leads and fine needle electrodes. Needle insertion is performed in a sitting position in an outpatient setting on either leg adhering to the manufacturers protocol (and specialist training). Treatment is for 30 mins weekly for a duration of 12 weeks. Validated sham stimulation - insertion of the urgent PC needle subcutaneously at the same site with electrical stimulation delivered to the distal foot using TENS. MEASUREMENT OF COSTS AND OUTCOMES: Primary outcome variable: change in weekly FI episodes [calculated from bowel diaries] expressed as proportion of patients achieving = 50% reduction in FI episodes per week. Secondary outcomes: (1) percentage change FI episodes per week, (2) numeric decrease in FI episodes per week, (3) validated patient-rated quantitative outcomes including symptom severity score (Cleveland Clinic Score), disease-specific: FI-QOL, and generic: EQ-5D QOL measures, (4) FI-specific patient-centered outcomes (5 validated key issues), (5) Likert scales of patients global impression of success (0-10), (6) Short urinary symptom assessment. Adverse events and anti-diarrhoeal drug usage will also be recorded. Economic analysis will measure direct NHS costs with utilities derived from the EQ-5D. |
ISRCTN* number: | ISRCTN 88559475 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN88559475 |
Project Protocol: |
Project protocol (pdf format, 661 kbytes) |
URL of this page: |
http://www.hta.ac.uk/2530 |
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