Randomized double-blind crossover study of alternative stimulator settings in sacral nerve stimulation for faecal incontinence

被引:30
作者
Duelund-Jakobsen, J. [1 ,2 ]
Dudding, T. [2 ]
Bradshaw, E. [2 ]
Buntzen, S. [1 ]
Lundby, L. [1 ]
Laurberg, S. [1 ]
Vaizey, C. [2 ]
机构
[1] Aarhus Univ Hosp, Dept Surg P, Surg Res Unit, DK-8000 Aarhus C, Denmark
[2] St Marks Hosp, Physiol Unit, Harrow, Middx, England
关键词
ELECTRICAL-STIMULATION; SINGLE-CENTER; NEUROMODULATION; EXPERIENCE; MODULATION;
D O I
10.1002/bjs.8867
中图分类号
R61 [外科手术学];
学科分类号
摘要
Background: Sacral nerve stimulation is an established treatment for faecal incontinence. Nearly half of all patients experience loss of efficacy at some point. Standard reprogramming restores efficacy for some, but not all, patients. This study aimed to determine whether alternative stimulator settings would increase treatment efficacy. Methods: Patients with sustained loss of efficacy were recruited from two international specialist centres. A number of alternative stimulation parameters were tested using a double-blind randomized crossover study design. Stimulation settings tested were pulse frequencies of 6.9 and 31 Hz, and pulse widths of 90 and 330 mu s, compared with one standard setting of 14 Hz/210 mu s. Treatment efficacy was evaluated using a disease-specific quality-of-life score (Fecal Incontinence Quality of Life Scale, FIQLS) and a bowel habit diary completed before randomization, during the study period and after 3 months of follow-up with one preferred setting. Results: Fifteen patients were analysed. With one preferred setting, three of four subdomains in the FIQLS improved significantly. The mean(s.d.) total number of incontinence episodes dropped from 11.7(10.8) to 4.8(4.5) per 3 weeks (P = 0.011) and improvements were maintained after 3 months of follow-up. Optimal pacemaker settings were individual, but a trend towards highest patient satisfaction and improved treatment outcome was evident for high-frequency stimulation (31 Hz/210 mu s), which was preferred by eight of the 15 patients. Conclusion: Patients experiencing loss of efficacy can experience improvement if alternative pacemaker settings are tested. High-frequency stimulation (31 Hz/210 mu s) was preferred by more than half of the patients, and improved treatment outcome was sustained at 3 months. Registration number: NCT01254695 (http://www.clinicaltrials.gov). Copyright (c) 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
引用
收藏
页码:1445 / 1452
页数:8
相关论文
共 36 条
[1]  
Agnew WF, 1999, MUSCLE NERVE, V22, P1393, DOI 10.1002/(SICI)1097-4598(199910)22:10<1393::AID-MUS9>3.0.CO
[2]  
2-E
[3]   Long-Term Outcome of Sacral Nerve Stimulation for Fecal Incontinence [J].
Altomare, Donato F. ;
Ratto, Carlo ;
Ganio, Ezio ;
Lolli, Paola ;
Masin, Alessandra ;
Villani, Roberto D. .
DISEASES OF THE COLON & RECTUM, 2009, 52 (01) :11-17
[4]   Sacral nerve stimulation for faecal incontinence: optimizing outcome and managing complications [J].
Dudding, T. C. ;
Hollingshead, J. R. ;
Nicholls, R. J. ;
Vaizey, C. J. .
COLORECTAL DISEASE, 2011, 13 (08) :E196-E202
[5]   Improving the efficacy of sacral nerve stimulation for faecal incontinence by alteration of stimulation parameters [J].
Dudding, T. C. ;
Vaizey, C. J. ;
Gibbs, A. ;
Kamm, M. A. .
BRITISH JOURNAL OF SURGERY, 2009, 96 (07) :778-784
[6]   Sacral neuromodulation for the treatment of fecal incontinence and urinary incontinence in female patients: long-term follow-up [J].
El-Gazzaz, Galal ;
Zutshi, Massarat ;
Salcedo, Levilester ;
Hammel, Jeff ;
Rackley, Raymond ;
Hull, Tracy .
INTERNATIONAL JOURNAL OF COLORECTAL DISEASE, 2009, 24 (12) :1377-1381
[7]   The Effect of Sacral Nerve Modulation on Cerebral Evoked Potential Latency in Fecal Incontinence and Constipation [J].
Giani, Iacopo ;
Novelli, Eugenio ;
Martina, Stefania ;
Clerico, Giuseppe ;
Luc, Alberto Realis ;
Trompetto, Mario ;
Malaguti, Silvia ;
Nicholls, John ;
Ganio, Ezio .
ANNALS OF SURGERY, 2011, 254 (01) :90-96
[8]   Sacral nerve stimulation increases activation of the primary somatosensory cortex by anal canal stimulation in an experimental model [J].
Griffin, K. M. ;
Pickering, M. ;
O'Herlihy, C. ;
O'Connell, P. R. ;
Jones, J. F. X. .
BRITISH JOURNAL OF SURGERY, 2011, 98 (08) :1160-1169
[9]  
Hetzer F H, 2005, Praxis (Bern 1994), V94, P681
[10]   Sacral nerve stimulation for faecal incontinence: results from a single centre over a 10-year period [J].
Hollingshead, J. R. F. ;
Dudding, T. C. ;
Vaizey, C. J. .
COLORECTAL DISEASE, 2011, 13 (09) :1030-1034