Device outcomes in pediatric sacral neuromodulation: A single center series of 187 patients.

INTRODUCTION: Pediatric sacral neuromodulation (SNM) device duration before revision or removal is not well known. Furthermore, secondary surgeries serve as surrogates for key outcomes including complications and symptom improvement. OBJECTIVE: We sought to study the rate and causes of secondary surgeries in pediatric SNM patients. STUDY DESIGN: We assessed our cohort of pediatric SNM patients for secondary surgeries (revision or removal). Baseline patient characteristics associated with secondary surgery were analyzed with Fisher's exact test. Kaplan-Meier analysis was used to describe secondary-surgery-free device survival. RESULTS: 187 pediatric patients underwent sacral neuromodulation at our institution between 2002 and 2019. 7 (4%) patients did not have a permanent device placed due to poor response during an externalized lead trial period, leaving 180 patients with permanent implanted devices. Over a median follow-up of 3.9 years (IQR 2.0 to 6.3), there were 154 total secondary surgeries. There were 83 device revisions, with 89% of revisions for a non-functioning device, 8% for pain, and 2% for infection. Of the non-functioning devices, 11% were due to battery depletion and the rest were due to lead fracture or dislodgement. Permanent device removal was performed in 71 (39%) patients, with 38% of these for unfavorable reasons (6% infection, 8% pain, 24% no longer effective) and 62% for favorable reasons (symptom improvement or resolution). Of patient baseline characteristics, only device duration was associated with favorable removal (p < 0.01). On Kaplan-Meier analysis, 5 year device secondary-surgery-free survival was 32% for any secondary surgery (favorable or unfavorable) and was 47% for unfavorable secondary surgery. At last follow-up, 74% of patients were in a favorable position (using the device, trialing with device off, or device had been removed for improvement) while 26% of patients were requiring other treatments due to device problem or removal. DISCUSSION: Describing the likelihood of subsequent surgery is an important aspect of patient and guardian counseling concerning pediatric SNM. Our cohort had a 68% 5 year all-cause reoperation rate. However, in a theoretical perfect world, pediatric SNM reoperation rate would be 100% after adequate follow-up (either for battery replacement, or device explantation for improvement). CONCLUSIONS: While sacral neuromodulation in our cohort of children carried a high (68% 5-year) reoperation rate (whether for complication or symptom improvement), the majority (74%) of these patients with previously refractory symptoms either continue to use their device or have had significant symptom improvement to permit device removal at moderate-term (median 3.9 year) follow-up.

Sacral neuromodulation for the dysfunctional elimination syndrome: a 10-year single-center experience with 105 consecutive children.

OBJECTIVE: To evaluate our initial experience using sacral neuromodulation via implanted pulse generator as a treatment for children with dysfunctional elimination syndrome and symptoms refractory to maximum medical therapy. MATERIALS AND METHODS: There were 105 consecutive patients who underwent a 2-stage procedure with a trial period (n = 89) or a single procedure (n = 16) for device implantation. They were followed up prospectively for a median of 2.72 years (average, 3.18 years; range, 0.01-9.63 years) for symptom improvement and resolution. RESULTS: Nearly all children (99 of 105 [94%]) experienced improvement of at least 1 symptom; 12 of 105 patients (11%) had at least 1 symptom worsen. Urinary incontinence, constipation, frequency and/or urgency, and nocturnal enuresis improved in 89 of 101 (88%), 73 of 92 (79%), 54 of 81 (67%), and 59 of 89 (66%) children, respectively, and resolved in 41 of 101 (41%), 37 of 92 (40%), 23 of 81 (28%), and 25 of 89 (28%) children, respectively. Outcomes among patients who did and did not undergo the trial were not significantly different (P = .19-1.00), and only 2 of 88 patients did not undergo permanent implantation. Reoperations (n = 85) occurred in 59 of 105 children (56%), mainly for device malfunction (n = 42), whereas explantation was performed in 36 of 104 children (35%) at an average of 2.68 years since implantation (median, 2.36 years; range, 0.03-9.04 years), mainly for complete symptom resolution (n = 12). Explantation for any reason was less common after single-stage procedures (1 of 16 [6%] vs 35 of 88 [40%] patients; P = .01). CONCLUSION: Sacral neuromodulation should be considered for children with dysfunctional elimination syndrome whose symptoms are refractory to maximum medical therapy understanding that the risk of reoperation is >50%. Elimination of the trial period reduces the number of general anesthetics without sacrificing outcomes.

Sacral neuromodulation in children with dysfunctional elimination syndrome: description of incisionless first stage and second stage without fluoroscopy.

OBJECTIVES: To detail a percutaneous technique of sacral nerve neuromodulation (SN) that eliminates the first-stage incisions and the need for second-stage fluoroscopy. Our group has previously described the results of SN in children with medically refractory dysfunctional elimination syndrome. The drawbacks to SN include the use of fluoroscopy and the need to reopen recent skin incisions during the second stage. This results in increased radiation exposure, poor cosmesis, and possible wound infection. METHODS: The incisionless first stage consisted of percutaneously tunneling the temporary external appliance to the contralateral axillary line at the buttock after localization of the S3 nerve root and placement of a quadripolar tined lead under fluoroscopic guidance. A subcutaneous bolus of methylene blue marked the lead connector site, obviating the need for later fluoroscopic localization to place the implantable pulse generator at the second stage. RESULTS: A total of 27 children with refractory dysfunctional elimination syndrome underwent SN using the InterStim device. Of the 27 patients, 19 underwent our modified technique. The operative time for our modified tunneling and placement technique was < or = 2 minutes. The mean hospital stay was 0.6 day, with no patient requiring postoperative intravenous narcotics. At a mean follow-up of 35.9 months, no wound infections had occurred in the incisionless cohort compared with 1 postoperative wound infection requiring device explantation in the conventional lead placement group. CONCLUSIONS: The incisionless technique of SN device implantation is technically simple, quick to perform, and results in decreased radiation exposure, excellent pain control, and improved cosmesis without compromising the outcomes.

Sacral neuromodulation for the dysfunctional elimination syndrome: a single center experience with 20 children.

PURPOSE: Recent advances in neuromodulation have demonstrated promise in treating children with the dysfunctional elimination syndrome refractory to medical management. Sacral nerve stimulation with the InterStim implantable device has been used in adults for management of chronic urinary complaints. However, there are few data regarding the usefulness of sacral nerve stimulation in children. We report our experience with sacral nerve stimulation for severe dysfunctional elimination syndrome. MATERIALS AND METHODS: A total of 20 patients 8 to 17 years old with the dysfunctional elimination syndrome refractory to maximum medical treatment underwent sacral nerve stimulation at our institution. Patients were followed prospectively for a median of 27 months after the procedure. RESULTS: Urinary incontinence, urgency and frequency, nocturnal enuresis and constipation were improved or resolved in 88% (14 of 16), 69% (9 of 13), 89% (8 of 9), 69% (11 of 16) and 71% (12 of 17) of the patients, respectively. Urinary retention requiring intermittent catheterization persisted in 75% of the patients (3 of 4) despite sacral nerve stimulation. Complications requiring operative treatment occurred in 20% of the patients (4 of 20). Following marked symptomatic improvement 2 devices were explanted at 20 and 19 months following placement, and both patients have remained symptom-free. CONCLUSIONS: Sacral nerve stimulation is effective in the majority of our patients, and should be considered in children with severe dysfunctional elimination syndrome refractory to maximum medical treatment.

Preliminary results of sacral neuromodulation in 23 children.

PURPOSE: Sacral nerve stimulation with InterStim is approved in the United States for use in adults. Limited data on the effectiveness of sacral nerve stimulation in children are available. We report our experience with patients who underwent InterStim placement for the treatment of severe dysfunctional elimination syndrome, which is defined as a constellation of functional urinary and gastrointestinal symptoms in patients without anatomical anomalies or obvious neurological disease, in whom intensive medical and behavioral therapies have failed to improve symptoms. MATERIALS AND METHODS: A total of 23 patients 6 to 15 years old with presenting symptoms of dysfunctional voiding, enuresis, incontinence, urinary tract infections, bladder pain, urinary retention, urgency, frequency, constipation and/or fecal soiling were followed for a mean of 13.3 months after InterStim placement. RESULTS: Of the 19 patients with urinary incontinence 3 (16%) had complete resolution, 13 (68%) had improvement, 2 (11%) were unchanged and 1 (5%) was worse (sign test, p = 0.002). Among the 16 patients with nocturnal enuresis 2 (13%) had resolution, 9 (56%) improved, 4 (25%) were unchanged and 1 (6%) was worse (sign test, p = 0.0063). Of the 15 patients with urinary retention requiring intervention 9 (60%) had improvement and 1 had worsening symptoms (sign test, p = 0.022), while 2 of 6 patients (33%) on intermittent catheterization were able to stop. One patient had development of new incontinence and enuresis. Bladder pain, urgency, frequency and constipation improved in 67% (8 of 12), 75% (12 of 16), 73% (11 of 15) and 80% (12 of 15) of the patients, respectively. Medications required postoperatively decreased by an average of 3 per patient (p < 0.001). The overall patient satisfaction rate was 64%, while that of the caregiver was 67%. Two leads were explanted from the 23 patients. Complications encountered included 1 seroma, 1 episode of skin sensitivity, 2 device failures and 1 lead revision. CONCLUSIONS: Sacral nerve stimulation in children is an option for carefully selected patients who have failed other therapies. Our results show that sacral nerve stimulation was effective in the majority of patients with the dysfunctional elimination syndrome. However, longer followup is needed.