NCT07862673Not yet recruiting
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
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.
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 1 Oct 2026
- Start date
- 5 Oct 2026
- Primary completion date
- 1 Oct 2029
- Lead sponsor
- Region Skane
- Diseases
- Colorectal cancer
- NCT number
- NCT07862673
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 5 Oct 2026 to the primary completion date, 1 Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Inability to be able to communicate both verbally and in written Swedish language
- Pregnancy or intention to become pregnant
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Surgery. Pelvic Floor Centre Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.