Predicting implantation with a neuromodulator using two different test stimulation techniques: A prospective randomized study in urge incontinent women

Abstract

Aims: The purpose of this study was to determine whether a percutaneous needle electrode (PNE) technique or a surgical first stage lead placement (FSLP) better predicted whether a patient would progress to implantation of a pulse generator (IPG) in older urge incontinent women.

Methods: Thirty subjects > or =55 years with refractory urge incontinence who had been selected to undergo a test stimulation procedure were randomized to either PNE or FSLP. Thirteen underwent PNE placement and seventeen underwent FSLP placement. If during the test stimulation period subjects had greater than 50% improvement in their incontinence parameters they qualified for permanent lead and/or IPG implantation of the Interstim device.

Results: Twenty-one subjects (70%) responded to the test stimulation and underwent implantation, 15/17 (88%) in the FSLP group and 6/13 (46%) in the PNE group. Subjects who were randomized to the FSLP group were significantly more likely to proceed to implantation of the IPG (P = 0.02) than those in the PNE group. There was no significant difference in demographics, pre-test stimulation incontinence parameters or post-stimulation visual analog pain scores between the randomized groups or between test stimulation responders and non-responders. When comparing FSLP and PNE responders, there was no significant difference in the percent improvement in 24-hr pad weight, daily pad usage, or daily incontinence.

Conclusion: FSLP better predicted progression to implantation of the IPG than a test stimulation with a PNE in an older urge incontinent cohort.