Volker Kahlke1, Heidi Topic, Hans G Peleikis, Johannes Jongen. 1. 1Proctological Office Kiel, Department of Surgical Proctology, Park-Klinik, Kiel, Germany 2School of Medicine, Christian-Albrechts-University, Kiel, Germany 3Department of Internal Medicine, Imland Klinik, Rendsburg, Germany.
Abstract
BACKGROUND: Although sacral nerve modulation has become an important tool for the treatment of fecal incontinence, prospective, randomized data are still rare. OBJECTIVE: To determine the effectiveness of sacral nerve modulation in a prospective randomized crossover study DESIGN: : Prospective randomized crossover study SETTING: : Proctological Office and Department of Surgical Proctology at a private hospital. PATIENTS: A total of 31 consecutive patients (31 women) aged 55 ± 12 years (median ± SD) with fecal incontinence were enrolled between February 2012 and December 2012. INTERVENTIONS:All patients underwent sacral nerve modulation through a staged implantation procedure between 2009-2011. After a median of 26.8 months following implantation, 16 of the 31 patients agreed to be randomized in a crossover design to stimulation ON or OFF, each for a 3-week period. After the two periods (ie, 6 weeks), while still blinded to the stimulator status, the patients chose which stimulation period (first or second) they preferred. The mode of stimulation corresponding to the selected period was then continued for 3 months (final period). MAIN OUTCOME MEASURES: Frequency of bowel movements, frequency of fecal incontinence and urgency episodes, severity scores, preference for ON or OFF. RESULTS: The frequency of fecal incontinence episodes and Cleveland Clinic Incontinence Score (CCIS) were both significantly lower in the ON period than the OFF period (p < 0.005) during the crossover phase of the study. All patients decided to stay in the ON mode for the final period and have continued in the ON mode until now. LIMITATIONS: Small patient numbers. CONCLUSIONS: The significant improvement in fecal incontinence during the ON period, as compared to the OFF period, makes it unlikely that the observed benefits of sacral nerve modulation are due to a placebo effect.
RCT Entities:
BACKGROUND: Although sacral nerve modulation has become an important tool for the treatment of fecal incontinence, prospective, randomized data are still rare. OBJECTIVE: To determine the effectiveness of sacral nerve modulation in a prospective randomized crossover study DESIGN: : Prospective randomized crossover study SETTING: : Proctological Office and Department of Surgical Proctology at a private hospital. PATIENTS: A total of 31 consecutive patients (31 women) aged 55 ± 12 years (median ± SD) with fecal incontinence were enrolled between February 2012 and December 2012. INTERVENTIONS: All patients underwent sacral nerve modulation through a staged implantation procedure between 2009-2011. After a median of 26.8 months following implantation, 16 of the 31 patients agreed to be randomized in a crossover design to stimulation ON or OFF, each for a 3-week period. After the two periods (ie, 6 weeks), while still blinded to the stimulator status, the patients chose which stimulation period (first or second) they preferred. The mode of stimulation corresponding to the selected period was then continued for 3 months (final period). MAIN OUTCOME MEASURES: Frequency of bowel movements, frequency of fecal incontinence and urgency episodes, severity scores, preference for ON or OFF. RESULTS: The frequency of fecal incontinence episodes and Cleveland Clinic Incontinence Score (CCIS) were both significantly lower in the ON period than the OFF period (p < 0.005) during the crossover phase of the study. All patients decided to stay in the ON mode for the final period and have continued in the ON mode until now. LIMITATIONS: Small patient numbers. CONCLUSIONS: The significant improvement in fecal incontinence during the ON period, as compared to the OFF period, makes it unlikely that the observed benefits of sacral nerve modulation are due to a placebo effect.
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: Eleanor McAlees; Paul F Vollebregt; Natasha Stevens; Tom C Dudding; Anton V Emmanuel; Paul L Furlong; Shaheen Hamdy; Richard L Hooper; James F X Jones; Christine Norton; P Ronan O'Connell; S Mark Scott; Charles H Knowles Journal: Trials Date: 2018-06-26 Impact factor: 2.279