New sacral neuromodulation lead for percutaneous implantation using local anesthesia: description and first experience.
OBJECTIVE
In functional urology today chronic stimulation of the sacral nerves has become one of the most accepted methods of stimulation treatment. Many studies have described the advantage of test stimulation prior to implanting the definitive system to enable effective patient selection. We studied a method aimed at improving lead anchoring by developing a self-blocking electrode with a simple placement procedure, in the process creating a 2-stage approach to full percutaneous implantation that allows a long screening period during the first temporary stimulation stage.


METHODS
A new tined lead was specifically designed to allow minimally invasive percutaneous lead placement requiring no incision and no additional fascial anchoring. From September 2001 to November 2002, 15 consecutive patients (3 males and 12 females) 27 to 70 years old (mean age 49) underwent this procedure and were prospectively evaluated. No PNE test was performed.


RESULTS
Following the first stage screening phase 12 patients were implanted with the implantable pulse generator (IPG), while 3 who did not respond positively to test stimulation (neurogenic voiding dysfunction, urge incontinence and neurogenic urge incontinence in 1 each) did not undergo IPG implantation and had the tined lead removed under local anesthesia. We did not observe any lead displacement during the screening period (average 38.8 days) or during followup of IPG implanted cases (average 11 months, range 5 to 19).


CONCLUSIONS
Our results show that the new tined anchoring system is a reliable way to allow truly minimally invasive placement of the chronic lead.
Spinelli
Michele
M
Ospedale Fornaroli, Magenta, Via Vittadini 21, 20136 Milan, Italy. m.spinelli@iol.it
Giardiello
Gianluca
G
Gerber
Martin
M
Arduini
Andrea
A
van den Hombergh
Ubi
U
Malaguti
Silvia
S
D000328:Adult; D000368:Aged; D001187:Artificial Organs; D004599:Electric Stimulation Therapy / Q000295:instrumentation*; D004567:Electrodes, Implanted; D005260:Female; D005471:Fluoroscopy; D006801:Humans; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures; D011474:Prosthesis Design; D012447:Sacrum / Q000294:innervation; D013127:Spinal Nerves / Q000503:physiopathology*; D016896:Treatment Outcome; D001750:Urinary Bladder, Neurogenic / Q000503:physiopathology / Q000628:therapy*; D014549:Urinary Incontinence / Q000503:physiopathology / Q000628:therapy*; D016055:Urinary Retention / Q000503:physiopathology / Q000628:therapy*