Sacral Neuromodulation Effective and Safe in Patients with Neurologic Lower Urinary Tract Dysfunctions
Introduction
Neurogenic lower urinary tract dysfunctions (nLUTD) comprise storage and voiding symptoms or a combination of both. Sacral neuromodulation (SNM) has been used in carefully selected patients with nLUTD for more than 20 years. Although SNM has been described as a treatment in the recent guidelines by European Association of Urology, there are no concrete recommendations. With the availability of new full-body magnetic resonance imaging (MRI)-safe SNM devices, there is a growing interest in these indications.
Aim
Systematic literature review and meta-analysis of studies reporting the safety and effectiveness of SNM test stimulation and chronic SNM with permanent implant in patients with nLUTD was performed.
Method
Study Design
- Systematic literature review and meta-analysis
- A systematic literature research was conducted using Embase, MEDLINE, MEDLINE In-Process Citations & Daily Update, MEDLINE e-Pub ahead of print, Cochrane Central Register of Controlled Trials (CENTRAL), NIH Clinicaltrials.gov, and WHO International Clinical Trials Registry Platform (ICTRP) between 1998 and March 2020, supplemented by a hand search.
Endpoints
- Success rate defined as >50% improvement of symptoms
- Percentage and type of adverse events (AEs) were analyzed to assess safety
Results
- The systematic literature review included 47 studies.
- The mean age of the patient population ranged between 16.75 to 63 years and 59.9% were females.
- A total of 21 studies (n=887) and 24 studies (n=428) were included in the meta-analysis of test SNM and permanent SNM respectively.
- The pooled success rate of SNM test stimulation was 66.2%. The test success rates varied greatly depending on neurogenic conditions.
- The success rate of pooled permanent SNM was 84.2%.
- Sensitivity analyses was done excluding the studies with less than 10 patients and the results revealed pooled success rates of 64.2% and 82.9% for test SNM and permanent SNM respectively.
- The most common AEs were loss of effectiveness, infection, pain at implant site, and lead migration with incidence of 4.7%, 3.6%, 3.2%, and 3.2%, respectively. Adverse stimulation was reported in 2.0% of patients.
- Limitations entail lower level of evidence (Oxford classification 3-4) of included studies, significant risk of bias, small sample sizes in some studies, the inclusion of retrospective case series, substantial between-study heterogeneity, heterogeneous patient populations, insufficient disease classification, and variations in terms of outcome parameters as well as techniques.
- Additionally, there is paucity of long-term data.
Conclusion
- The findings of this meta-analysis demonstrate that permanent sacral neuromodulation (SNM) is not only beneficial in patients with various neurogenic lower urinary tract dysfunctions (nLUTDs) but also has high overall success rates, similar to idiopathic patients.
- SNM was found to be safe in such patients.
- However, prospective trials with more vigorous study designs and/or registries are warranted before definitive conclusions can be drawn.
Adv Ther. 2021 Apr;38(4):1987-2006. Doi: 10.1007/s12325-021-01650-9.
