Elsevier

Urology

Volume 73, Issue 4, April 2009, Pages 731-735
Urology

Female Urology
Incidence and Predictors of Complications With Sacral Neuromodulation

https://doi.org/10.1016/j.urology.2008.11.047Get rights and content

Objectives

To determine the incidence and predictors of complications with sacral nerve stimulation (SNS).

Methods

A prospective, longitudinal analysis of all patients treated with SNS was performed to define the incidence of complications and identify the predictors of these adverse events (AEs). All patients underwent staged SNS placement with the InterStim device for treatment of refractory voiding dysfunction. The patients were followed up for evidence of AEs and device efficacy. The patient and device variables were examined statistically for evidence of predictive value.

Results

From September 2001 to March 2008, 221 patients with a mean age of 48.8 years underwent SNS lead placement for the treatment of intractable urinary urgency/frequency (n = 121), urge incontinence (n = 63), or urinary retention (n = 37). Of this group, 202 patients (91.4%) experienced a >50% improvement in symptoms and underwent implantable pulse generator placement. At a mean follow-up of 36.9 months, 67 patients (30.3%) had experienced AEs (pain in 6, elective removal in 10, lack of efficacy in 11, trauma in 18, infection in 7, hematoma in 3, and lead migration in 12) requiring 44 lead revisions and 47 implantable pulse generator revisions. The significant predictors of AEs included a history of trauma (P < .001), a change in body mass index class (P < .001), enrollment in a pain clinic (P = .008), the duration of follow-up (P = .002), and a history of AEs (P < .001).

Conclusions

The results of our study have shown that SNS is an effective treatment for patients with intractable voiding dysfunction. Complications are not uncommon but can be minimized with better patient selection.

Section snippets

Material and Methods

After obtaining institutional review board approval, a prospective, longitudinal, observational study was performed to define the incidence and predictors of complications associated with SNS. All patients presented with subjective complaints of refractory urinary urgency and frequency, urge incontinence, or urinary retention. Patients underwent a complete history and physical examination, urinalysis, and urine culture. A 1-week voiding log was obtained, and the patients were subsequently

Results

From September 13, 2001 to March 1, 2008, 221 patients were evaluated and deemed appropriate candidates for SNS. The indication for intervention in the 188 women and 33 men was refractory urinary urgency/frequency (n = 121), urge incontinence (n = 63), and refractory urinary retention (n = 37). The mean age of the cohort was 48.77 years (range 18-88). The mean BMI was 28.61 kg/m2 (range 15.9-52.7). Of the 221 patients, 8 were confined to a wheelchair. Of the 221 patients, 83 were commercially

Comment

Tanagho and Schmidt5 first reported on the use of SNS for the treatment of refractory lower urinary tract dysfunction in 1981. Nearly 16 years later, the Food and Drug Administration approved the first commercially available SNS device (InterStim) for the treatment of refractory urinary urgency/frequency and urge incontinence. Two years later, InterStim was approved for the treatment of nonobstructive urinary retention. Since its approval, numerous retrospective studies and prospective trials

Conclusions

Sacral neuromodulation is an effective treatment option for select patients with refractory voiding dysfunction. Although complications and revisions should be expected, improved patient selection could help to avoid many of these untoward events. Future multicenter trials are needed to corroborate these findings and should address not only objective outcomes and overt complications, but also quality-of-life indexes as markers of success.

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C. Dobmeyer-Dittrich is a nonpaid educator for Medtronic.

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