Faecal Incontinence With Faecal Urgency, Rectal Cancer, Radiotherapy Side Effects, Low Anterior Resection Syndrome (LARS>20)
Conditions
Keywords
Rectal Cancer, Percutaneous Tibialis Nerve Stimulation (PTNS), Low Anterior Resection Syndrome
Brief 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.
Detailed description
The HIPLARS study is a Swedish clinical research project investigating whether an intensive form of Percutaneous Tibial Nerve Stimulation (PTNS) can improve faecal incontinence (FI) in patients who develop Low Anterior Resection Syndrome (LARS) after rectal cancer surgery. LARS commonly causes frequent bowel movements, urgency, and faecal incontinence, which can significantly reduce quality of life. All participants receive the current standard treatment for FI, including bowel management, pelvic floor exercises, biofeedback, and, if needed, mini-enemas. The study compares this standard treatment with an intensified PTNS treatment, a minimally invasive nerve stimulation therapy that may provide longer-lasting symptom relief. Participants whose symptoms persist after six months may also be offered PTNS. The study will include approximately 60 participants across three Swedish clinics and lasts 12 months. Depending on the assigned study group, participants will attend 17-29 clinic visits and receive 12-24 PTNS treatment sessions, each lasting about 30 minutes. Assessments include medical examinations, ultrasound, questionnaires, quality-of-life surveys, and bowel diaries. Participation is voluntary, and participants may withdraw at any time without affecting their future medical care. Researchers may also end participation for medical reasons or if study procedures are not followed. PTNS is already an established treatment with a low risk of side effects. Possible risks include mild discomfort from the needle insertion and occasional minor bleeding at the insertion site. Serious side effects are uncommon. Personal and medical information will be kept confidential, stored securely, and handled in accordance with GDPR and Swedish law. Study results may be published, but participants' identities will remain confidential. The study is conducted by the Pelvic Floor Centre, Department of Surgery, Skåne University Hospital (SUS) Malmö, has been approved by the Swedish Ethical Review Authority, and is covered by standard patient and pharmaceutical insurance. Participants can contact the study team at any time with questions or concerns.
Interventions
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.
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Crossover option included for Control Arm participants without significantly improved symtoms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change 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 change of the LARS score from Major LARS to Minor or No LARS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement or change of at least 50 per cent in the number faecal incontinence episodes | Outcome measures to be assessed at baseline, after 6 weeks, 3 months and 6 month treatment being the primary end point. | An achievement of ≥ 50% change in weekly faecal incontinence episodes (FIEs) for secondary outcome |
Countries
Sweden
Contacts
CONTACTLouis B Johnson, Associate Professor of Surgery
CONTACTAlejandro Lusilla Lopez, MD Consultant
PRINCIPAL_INVESTIGATORLouiis B Johnson, Associate Professor of Surgery
Region Skåne - University of Malmö / Lund
Outcome results
None listed