A A van der Wilt1, G Giuliani2, C Kubis3, B P W van Wunnik1, I Ferreira4,5, S O Breukink1, P A Lehur3, F La Torre2, C G M I Baeten1. 1. Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands. 2. Department of Surgery, Università degli Studi di Roma 'Sapienza', Rome, Italy. 3. Department of Surgery, Institut des Maladies de l'Appareil Digestiv, University Hospital of Nantes, Nantes, France. 4. Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, The Netherlands. 5. Division of Epidemiology and Biostatistics, School of Public Health, Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia.
Abstract
BACKGROUND: The aim was to assess the effects of percutaneous tibial nerve stimulation (PTNS) in the treatment of faecal incontinence (FI) by means of an RCT. METHODS:Patients aged over 18 years with FI were included in a multicentre, single-blinded RCT. The primary endpoint was reduction in the median or mean number of FI episodes per week. Secondary endpoints were changes in measures of FI severity, and disease-specific and generic quality of life. Outcomes were compared between PTNS and sham stimulation after 9 weeks of treatment. RESULTS: A higher proportion of patients in the PTNS (13 of 29) than in the sham (6 of 30) group showed a reduction of at least 50 per cent in the median number of FI episodes/week (incidence rate ratio (IRR) 2·40, 95 per cent c.i. 1·10 to 5·24; P = 0·028), but not in the mean number of episodes/week (10 of 29 versus 8 of 30; IRR 1·42, 0·69 to 2·92; P = 0·347). The absolute median number of FI episodes per week decreased in the PTNS but not in the sham group (IRR 0·66, 0·44 to 0·98; P = 0·041), as did the mean number (IRR 0·65 (0·45 to 0·97); P = 0·034). Scores on the Cleveland Clinic Florida faecal incontinence scale decreased significantly in both groups, but more steeply in the PTNS group (mean difference -1·3, 95 per cent c.i. -2·6 to 0·0; P = 0·049). The aggregated mental component score of Short Form 36 improved in the PTNS but not in the sham group (mean difference 5·1, 0·5 to 9·6; P = 0·028). CONCLUSION: PTNS may offer a small advantage in the clinical management of FI that is insufficiently responsive to conservative treatment. The key challenge will be to identify patients who may benefit most from this minimally invasive surgical procedure. Registration number: NCT00974909 (http://www.clinicaltrials.gov).
RCT Entities:
BACKGROUND: The aim was to assess the effects of percutaneous tibial nerve stimulation (PTNS) in the treatment of faecal incontinence (FI) by means of an RCT. METHODS:Patients aged over 18 years with FI were included in a multicentre, single-blinded RCT. The primary endpoint was reduction in the median or mean number of FI episodes per week. Secondary endpoints were changes in measures of FI severity, and disease-specific and generic quality of life. Outcomes were compared between PTNS and sham stimulation after 9 weeks of treatment. RESULTS: A higher proportion of patients in the PTNS (13 of 29) than in the sham (6 of 30) group showed a reduction of at least 50 per cent in the median number of FI episodes/week (incidence rate ratio (IRR) 2·40, 95 per cent c.i. 1·10 to 5·24; P = 0·028), but not in the mean number of episodes/week (10 of 29 versus 8 of 30; IRR 1·42, 0·69 to 2·92; P = 0·347). The absolute median number of FI episodes per week decreased in the PTNS but not in the sham group (IRR 0·66, 0·44 to 0·98; P = 0·041), as did the mean number (IRR 0·65 (0·45 to 0·97); P = 0·034). Scores on the Cleveland Clinic Florida faecal incontinence scale decreased significantly in both groups, but more steeply in the PTNS group (mean difference -1·3, 95 per cent c.i. -2·6 to 0·0; P = 0·049). The aggregated mental component score of Short Form 36 improved in the PTNS but not in the sham group (mean difference 5·1, 0·5 to 9·6; P = 0·028). CONCLUSION:PTNS may offer a small advantage in the clinical management of FI that is insufficiently responsive to conservative treatment. The key challenge will be to identify patients who may benefit most from this minimally invasive surgical procedure. Registration number: NCT00974909 (http://www.clinicaltrials.gov).
Authors: R Rodríguez Carrillo; M D Ruiz Carmona; R Alós Company; A Frangi Caregnato; M Alarcón Iranzo; A Solana Bueno; R Lozoya Trujillo; E García-Granero Ximénez Journal: Tech Coloproctol Date: 2019-09-19 Impact factor: 3.781
Authors: Sadé L Assmann; Daniel Keszthelyi; Jos Kleijnen; Foteini Anastasiou; Elissa Bradshaw; Ann E Brannigan; Emma V Carrington; Giuseppe Chiarioni; Liora D A Ebben; Marc A Gladman; Yasuko Maeda; Jarno Melenhorst; Giovanni Milito; Jean W M Muris; Julius Orhalmi; Daniel Pohl; Yvonne Tillotson; Mona Rydningen; Saulius Svagzdys; Carolynne J Vaizey; Stephanie O Breukink Journal: United European Gastroenterol J Date: 2022-03-18 Impact factor: 6.866
Authors: Yoav Mazor; Gillian M Prott; Carol Sequeira; Michael Jones; Anastasia Ejova; John E Kellow; Margaret Schnitzler; Allison Malcolm Journal: Therap Adv Gastroenterol Date: 2020-06-10 Impact factor: 4.409