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Clinical Trials in Sweden / NCT07862673
Starting soon Not applicable

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

NCT07862673 · tracked via the Priya Life Science Sweden tracker
Sponsor
Region Skane
Phase
Not applicable
Started
2026-10-05
Last updated
2026-10-07

Condition(s) studied

Faecal Incontinence With Faecal Urgency

Investigational drug(s) / intervention(s)

Percutaneous Tibial Nerve Stimulation

Percutaneous Tibial Nerve Stimulation: A 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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. 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 Pregnancy or intention to become pregnant

Primary outcome measure(s)

  • Reduction in Low Anterior Resection Syndrome Score — Outcome measures to be assessed at baseline, after 6 weeks, 3 months and 6 month treatment being the primary end point.
    The primary outcome classifies patients as responders or non-responders, with a responder defined as someone having a reduction of the LARS score

Trial sites (1)

FacilityCityRegionStatus
Department of Surgery. Pelvic Floor Centre Malmö Skåne County

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07862673 on ClinicalTrials.gov ↗ ← All trials in Sweden