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.
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).
Inability to be able to communicate both verbally and in written Swedish language Patients with neurological diseases such as multiple sclerosis, diabetic neuropathy and Parkinson's disease.
Parallel
Percutaneous Tibial Nerve Stimulation
Procedure/SurgeryA total of PTNS 24 sessions, with 5 PTNS sessions per week (30 min each) for 4 weeks, thereafter 2 sessions per week for 2 weeks.
Reduction in Low Anterior Resection Syndrome Score
The primary outcome classifies patients as responders or non-responders, with a responder defined as someone having a reduction of the LARS score
Improvement or reduction of at least 50 per cent in the number faecal incontinence episodes
An achievement of ≥ 50% reduction in weekly faecal incontinence episodes (FIEs) for secondary outcome
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This trial is not recruiting at the moment. You can still explore other options:
