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.
