Infection Rate of a Prolonged Sacral Neuromodulation Test: A Large Retrospective Study.

OBJECTIVES: It is estimated that 3.8% to 12.5% of patients develop a device infection during the two to four weeks of the sacral neuromodulation (SNM) test, leading to removal of the entire system. It is possible to prolong the test phase up to the clinician's decision, particularly when benefits are unclear. The aim of our study is to assess the device infection rate in a prolonged SNM test. MATERIALS AND METHODS: We retrospectively enrolled patients who performed a prolonged SNM test (at least eight weeks) in the last five years (2017-2021). All procedures were performed using a standardized technique and the same prophylactic antibiotic protocol. In case of a clinical suspicion of infection, all components were explanted. Patient information (age at implantation, medical history of diabetes, metabolic syndrome, immunologic diseases, or chronic immunosuppressive therapy), surgical data (operative time, intraoperative complications), and infection data (timing of onset, symptoms reported, wound culture results) were recorded. RESULTS: We enrolled 232 patients who underwent a prolonged SNM test (mean duration 65.5 days). A local infection that led to the removal of the entire system occurred in six patients (2.6%). The gluteal pocket was always involved, and in two cases, infection was also extended to the exit point of the extension wire. No significant correlations with clinical data were found. Infection occurred beyond four weeks in two cases, between three and four weeks in three cases, and within two weeks in one case. Intraoperative wound culture was performed in five of six patients, and Staphylococcus aureus (S aureus) was isolated in four cases. One culture test gave negative bacterial growth results. CONCLUSIONS: The infection rate of a prolonged eight-week SNM test is low and does not differ from that reported in the literature for a two-to-four-week SNM test. S aureus remains the most frequent bacterium involved.

Do you really want to deactivate your sacral neuromodulation device during pregnancy? A single center case series.

INTRODUCTION AND HYPOTHESIS: The main objective of the study is to assess the efficacy and safety of sacral neuromodulation (SNM) during pregnancy. METHODS: We retrospectively enrolled patients who underwent SNM implantation in our center and subsequently became pregnant. The indication for SNM, timing of device de-activation (if performed), course of pregnancy and urological complications, duration of labor, childbirth term, delivery mode, congenital abnormalities and SNM dysfunctions after delivery were recorded. RESULTS: Fourteen pregnancies were recorded among 11 women undergoing SNM. Indications for device implantation were urinary retention (7 cases) and dysfunctional voiding (4 cases). Two patients carried on two and three pregnancies, respectively, with the device turned off since the first trimester. They both had to return to self-catheterization and developed recurring urinary tract infections. No major urological complications were recorded among the remaining nine women that kept the device on during pregnancy. A cesarean section was performed in four cases for obstetric reasons, and in seven cases it was planned by the urologist and gynecologist to avoid lead damage/displacement. Three pregnancies resulted in a vaginal delivery, and no association with term of delivery or duration of labor was observed. No congenital abnormalities related to SNM or lead displacement are reported, and only one patient required device removal because of significant loss of efficacy after childbirth. CONCLUSIONS: The use of SNM during pregnancy appears to be safe, without morbidity for the fetus. Moreover, risks associated with switching the device off may be greater than benefits and justify maintaining the electrical stimulation throughout pregnancy.

Sacral neuromodulation to treat voiding dysfunction in patients with previous pelvic surgery for deep infiltrating endometriosis: our centre's experience.

INTRODUCTION AND HYPOTHESIS: Voiding symptoms/dysfunctions (VS/Ds) after surgery for deep-infiltrating endometriosis (DIE) are frequent (20% of patients) and, together with bowel dysfunctions, may represent a de novo disorder due to surgical damage of the pelvic plexus or a worsening of pre-existent functional damage. Sacral neuromodulation (SNM) might improve voiding symptoms by treating dysfunctional voiding. The aim of this study is to report our experience with SNM in patients treated with surgery for DIE. METHODS: We retrospectively enrolled 13 patients with VS/Ds after surgery for DIE. All patients were investigated with urodynamic studies (UDS) and agreed to undergo SNM. Pre-existing VS/Ds, bowel disorders and pelvic pain, DIE surgical procedures, UDS and SNM test results were recorded. RESULTS: After surgery for DIE, functional bladder outflow obstruction and detrusor acontractility were observed in nine and four patients, respectively. Chronic pelvic pain was present in seven cases. Twelve patients developed constipation, whilst one patient had de novo faecal incontinence. After the SNM testing period, nine patients (69.2%) experienced a significant improvement of symptoms that led to definitive implant. Four patients (30.8%) had no symptom relief and the system was removed. CONCLUSIONS: Functional bladder outflow obstruction and urinary retention are the most common VS/Ds after surgery for DIE. SNM may be an effective option for these patients, probably due to its action in improving the dysfunctional voiding, which was likely to be already present as part of the "endometriotic syndrome" and got worse after pelvic surgery. Results for pelvic pain control and gastrointestinal disorders should not be underestimated.

Sacral neuromodulation and Botulinum toxin A for refractory idiopathic overactive bladder: a cost-utility analysis in the perspective of Italian Healthcare System.

OBJECTIVES: To assess the relative cost-effectiveness of two therapeutic strategies: one starting with sacral neuromodulation (SNM) versus one starting with Botulinum toxin A (BTX-A) for the management of refractory incontinent idiopathic overactive bladder (OAB) patients, from the perspective of the Italian National Health Service (INHS). METHODS: Direct medical costs (2011) and benefits (quality-adjusted life years-QALYs) were assessed over a ten-year time frame adapting to the Italian practice a published Markov model. Clinical inputs were based on the published literature and on the expert opinion. Resource consumption rates were provided by clinical experts; unit costs were collected from a single hospital accounting and from standard tariff lists and public prices. Interventional procedures and management of adverse events were costed through a micro-costing approach. The primary outcome was incremental costs per QALYs gained (i.e. differential costs divided by differential benefits). Deterministic (DSA) and probabilistic (PSA) sensitivity analyses were conducted to assess the robustness of the model. RESULTS: Starting with SNM appears to be cost effective (i.e. under 40.000/QALY) from year three (21,259/QALY) onwards and becomes dominant (i.e. more effective and less costly) at year ten: cumulative costs were 32,975 for early SNM and 33,309 for early BTX-A, while cumulative QALYs were 7.52 and 6.93, respectively. At year ten, DSA suggests the results robustness and 99.8 % of the PSA iterations fell within the cost-effectiveness threshold. CONCLUSIONS: A therapeutic strategy starting with SNM may be considered cost effective in the midterm and cost saving in the long-term treatment of idiopathic OAB from the INHS perspective.