A multicentre randomised controlled study of percutaneous tibial nerve stimulation (PTNS) for slow transit constipation: TS02

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Aim:Percutaneous tibial nerve stimulation (PTNS) is an electrical therapy applied through an acupuncture type needle via tibial nerve in the ankle. A pilot study has shown significant improvement in symptoms of slow transit constipation. The aim of the study was to assess the efficacy of PTNS for slow transit constipation compared with biofeedback therapy. Secondary aim: to determine the feasibility of maintenance therapy for participants who initially benefited from PTNS.Method:A randomised, intention-to-treat first phase treatment with either PTNS or biofeedback. Crossing-over or maintenance therapy as the second phase treatment will be optional. Theprimary endpoint will be theproportion of patients with an improvement in the score of more than one point of Patient Assessment of Constipation Quality of Life (PAC-QOL) score. Secondary endpoints: Agachan constipation score, number of bowel movement per week, Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM), Measure Yourself Medical Outcome Profile (MYMOP) and Patient Global Impression of Improvement (PGI-I). A total of 226 patients will be randomized to detect a difference of 22% in theproportion of patients achieving theprimary point between the two groups. It is expected the study will finish within 24 months.

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