Table 1.
Efficacy and AE of SNS in prospective trials.
| Study | Stimulation/implantation | Effectiveness+ | Quality of life | Device-related AE after implantation | Re-intervention and explantation | Follow up |
|---|---|---|---|---|---|---|
| Siegel and colleagues24
InSite Trial |
340/272 | 67% overall | Improved* | 22% undesirable change in stimulation 15% pain 13% ineffective |
33.5% re-intervention for battery 30.9% re-intervention for AE 19.1% explantation |
5 years 183 completers |
| Peeters and colleagues25 | 382/217 | 73% in retention 70% in UI 68% in U/F |
Not reported | 11.5% ineffective 1.8% malfunction 1.8% infection |
41% re-intervention 18% explantation |
Mean of 46.88 months |
| Al-zahrani and colleagues26 | 196/96 | 87.5% in retention 84.8% in UI |
Not reported | 37.5% ineffective 16.6% pain 0% infection |
39% re-intervention 20.8% explantation |
Median of 50.7 months |
| Van Kerrebroeck and colleagues4
MDT-103 post-approval study |
163/152 | 71% in retention 68% in UI 56% in U/F |
Not significant | 28.2% undesirable change in stimulation 27.6% pain 7.9% infection |
39.4% re-intervention 10.5% explantation |
5 years |
| Jonas and colleagues27
MDT-103 study group |
177/68 | 83% in retention | Not reported | 29.7% pain 8.4% lead migration 6.1% infection |
Not reported | 6 months |
| Siegel, Das and colleagues3,28
MDT-103 long-term follow up |
581/219 | 70% in retention 59% in UI 56% in U/F |
Improved§ | 29.7% pain 8.4% lead migration 6.1% infection |
33% re-intervention 10.5% explantation |
1.5–3 years |
| Hassouna and colleagues29
MDT-103 study group |
51/51 | 56% in U/F | Improved† | 29.7% pain 8.4% lead migration 6.1% infection |
33.3% revision 2% explantation |
6 months 50 completers |
| Schmidt and colleagues30
MDT-103 study group |
155/98 | 83% in UI | Improved† | 35% pain 7% lead migration |
32.5% revision 6.3% explantation |
6 months 58 completers |
+
Effectiveness: therapeutic success measured as >50% improvement in baseline variables; *quality of life measured through international Consultation on Incontinence Modular Questionnaire (ICIQ OABqol); §Health Related Quality of Life (HRQOL) or †SF-36 Health Survey.
AE, adverse events; SNS, sacral nerve stimulation; U/F, urgency/frequency syndrome; UI, urinary urge incontinence.