Department of Urology, Eberhard Karls University Tuebingen, Tuebingen, Germany.
BJU Int. 2013 Mar;111(3):485-91. doi: 10.1111/j.1464-410X.2012.11263.x. Epub 2012 Jun 28.
WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Sacral neuromodulation (SNM) is an effective treatment option of different pelvic-related dysfunctions. SNM evaluation by either temporary or permanent electrodes is generally accepted. Extended testing with temporary electrodes has been reported on before but less is known about infection-related risks during prolonged evaluation with definitive electrodes. The present findings show that prolonged testing (mean = 52.3 days) with permanent electrodes does not increase infection-associated explantation rates, although bacterial colonization was found in more than one-third of the patients. Prolonged SNM evaluation under everyday conditions might improve long-term success.
To evaluate the impact of prolonged stage 1 testing on bacterial electrode colonization, infection and treatment success.
In all, 21 patients who underwent sacral neuromodulation (SNM) for periods ≥1 month were prospectively evaluated; nine patients had overactive bladder syndrome (OAB), 10 had urinary retention, two had faecal incontinence (FI), and 13 had diabetes and overweight/obesity. After stage 1 testing electrode extension leads were microbiologically analysed to assess bacterial colonization. The primary measurements were pre- and post-SNM treatment comparisons based on patient-agreed criteria using an increased 70% minimum improvement rate; secondary measurements were bacterial colonization and impact of infection.
The mean stage 1 evaluation period was 52.3 days; 16 patients (76%) progressed to stage 2, and five patients were explanted due to inadequate improvement (<70%). There was bacterial colonization in 42.9% of patients and 38.2% of extension leads. Stage 2 patients showed no infection or wound-healing disorders at a mean follow-up of 33.9 months. The success rate for stage 2 implantation treatment was 94%.
There are few studies in the literature evaluating SNM testing periods vs the risk of clinically relevant implant infection rates. The present study shows that prolonged testing could potentially enhance treatment efficacy without infection-related explantations of the chronic implant, despite the identification of bacteria. SNM-implanted patients with diabetes mellitus or obesity should be followed closely. Clinicians might consider using prolonged testing under everyday conditions. Prolonged SNM stage 1 testing is a very effective minimally invasive treatment option to evaluate pelvic-related dysfunction.
评估延长 1 期测试对细菌电极定植、感染和治疗成功的影响。
共前瞻性评估 21 例接受骶神经调节（SNM）治疗且治疗时间≥1 个月的患者；9 例患者为膀胱过度活动症（OAB），10 例为尿潴留，2 例为粪便失禁（FI），13 例为糖尿病和超重/肥胖。在 1 期测试后，通过微生物分析延长的电极导联以评估细菌定植。主要测量指标是基于患者同意的标准，采用至少增加 70%的最小改善率，对 SNM 治疗前后进行比较；次要测量指标是细菌定植和感染的影响。
1 期评估的平均时间为 52.3 天；16 例（76%）患者进展至 2 期，5 例患者因改善不足（<70%）而被植入物取出。42.9%的患者和 38.2%的电极导联存在细菌定植。在平均 33.9 个月的随访中，2 期患者无感染或伤口愈合障碍。2 期植入物治疗的成功率为 94%。
文献中很少有研究评估 SNM 测试时间与临床相关植入物感染率风险的关系。本研究表明，尽管发现了细菌，但延长测试可能会提高治疗效果而不会导致慢性植入物发生与感染相关的取出。糖尿病或肥胖的 SNM 植入患者应密切随访。临床医生可能会考虑在日常情况下使用延长测试。延长 1 期 SNM 测试是评估与骨盆相关的功能障碍的一种非常有效的微创治疗选择。
