A Phase 3 interventional study of Percutaneous Tibial Nerve Stimulation in Faecal Incontinence and Bowel Incontinence, sponsored by Queen Mary University of London. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-28.
Sponsored by Queen Mary University of London · Phase 3, Interventional, and Treatment
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.
312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.
This study's enrollment of 227 is above the median of 50 across 216 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →Queen Mary University of London is the lead sponsor of 250 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sham electrical stimulation to forefoot by TENS
Device: Percutaneous Tibial Nerve Stimulation
Active PTNS via Urgent PC Neuromodulation device, Uroplasty
Device: Percutaneous Tibial Nerve Stimulation
Primary outcome: Binary - success or failure based on % patients achieving > or = 50% reduction in faecal incontinence episodes
From 2 weekly bowel diaries before and after treatment
Time frame: 3 months
Reduction in faecal incontinence episodes
Time frame: 3 months
Proportion of patients achieving >25%, >75% and 100% reduction in faecal incotinence episodes
Time frame: 3 months
Reduction in Cleveland Clinic Constipation Score
Time frame: 3 months
No study locations are listed for this record.
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Queen Mary University of London