Intensive Tibial Nerve Stimulation for Bowel Leakage After Rectal Cancer Surgery
Tests intensive tibial nerve stimulation for bowel leakage after rectal cancer surgery.
Plain-language title generated from the registry record
Registry title: Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
Key facts
- Where
- Malmö, SwedenSee the site
Where in Sweden
- Department of Surgery. Pelvic Floor CentreMalmö, SwedenNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Skane
- Trial code
- NCT07862673
- Record updated
- 23 October 2026
- Original description
This study aims to assess and evaluate the clinical efficacy of an intensified form of Percutaneous tibial nerve stimulation (PTNS) compared to standard conservative treatment for low anterior resection syndrome (LARS). A syndrome with symptoms such as faecal incontinence (FI), urgency to defecate and frequent bowel movements. Focus will be mainly on patients with significant faecal incontinence.Read full original descriptionShow less
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery.
This study aims to assess and evaluate the clinical efficacy of an intensified form of Percutaneous tibial nerve stimulation (PTNS) compared to standard conservative treatment for low anterior resection syndrome (LARS). A syndrome with symptoms such as faecal incontinence (FI), urgency to defecate and frequent bowel movements. Focus will be mainly on patients with significant faecal incontinence.
Participants will be randomized into 2 groups: Standard Care with bowel regulation or to High Intensive PTNS for 6 weeks.
Every treatment session will be at the clinic and take 30 minutes.
Standard care PTNS participants will have nurse contact once per week for 6 weeks
High Intensive PTNS participants will start with 5 sessions per week, which will the be phased out to 2 sessions per weeks during the 6 week period.
Follow up visits to the clinic will be at 3, 6 and 12 months after completion of study.
Patients in the Standard group whose symtoms have not improved significantly, will be given the option to try the High Intensive treatment option.
Inclusion: The presence of Faecal incontinence sufficiently severe to warrant intervention; Have undergone low anterior resection and with low anterior resection syndrome (LARS) score >20; The presence of incontinence for >6 months before inclusion in the study, failure of conservative treatment (e.g. fiber plus loperamide, biofeedback, bulking agents or TAI - transanal irrigation).
Exclusion: Patients with neurological diseases such as multiple sclerosis, diabetic neuropathy and Parkinson's disease; Medical conditions precluding stimulation, for example bleeding disorders, novel oral anticoagulants (NOACs), cardiac pacemaker or implantable defibrillator, peripheral vascular disease or ulcer, lower leg cellulitis; Severe cardiopulmonary disease with severe distal venous insufficiency, local skin lesion, low molecular heparin or; Chronic bowel diseases such as inflammatory bowel disease with chronic uncontrolled diarrhoea; Inability to be able to communicate both verbally and in written Swedish language; Pregnancy or intention to become pregnant.