12 Month Improvement in OAB Symptoms after PNE versus Stage 1 Lead Implant

Objectives: To compare 12-month symptomatic improvement in patients presenting with overactive bladder (OAB) who underwent placement of a sacral neuromodulation (SNM) device following either successful office peripheral nerve evaluation (PNE) or a two-stage approach to lead placement.

Methods: This is a retrospective matched cohort study of women diagnosed with non-neurogenic OAB who underwent SNM insertion via either a stepwise stage 1 lead implant then stage 2 battery implant or an office PNE trial followed by a combined lead and battery insertion (stage 1+2) between January 2016 and December 2021. Patients were matched 1:1 according to surgeon specialty (gynecology vs urology) and patient age. Subjective improvement in symptoms was determined by patient reported improvement at their most recent visit up to 12 months following battery insertion.

Results: A total of 160 patients were included (n=80 PNE and n=80 stage 1). The average age and BMI of the cohort was 64.2 (±16.2) years and 31.6 (±7.7) kg/m^2. 50% of the total cohort reported mixed incontinence symptoms while 18% reported fecal incontinence. 130 (81.3%) implants were performed by Urology and 30 (18.7%) by Urogynecology. Staged patients were more likely to have recurrent UTIs (25% vs 11.3%, p=0.023) and PNE patients trialed more OAB medications (p=0.02), including beta-3 agonists (p=0.008), compared to the staged group. They were also more likely to have attempted pelvic floor physical therapy for treatment (p=0.009). Women who underwent PNE had a longer interval to battery implant (46.3 ± 53.1 days) versus the stage 1 patients (14.3 ± 4.3 days), p< 0.0001. Of the cohort, 63.1% of patients reported symptomatic improvement at 12 months with no difference in documented improvement between the groups. The explant rate within 12 months for the total cohort was 8.8% (14) and the PNE group was more likely to undergo explant, but this was not statistically significant (11.3% vs 6.3%, P=0.26). Of the patients who were explanted, 78.6% had reported no improvement in their symptoms. 26 (16%) patients underwent an alternative treatment after SNM, including botox and medications. Additional treatment was not different between PNE vs stage 1. Patients who reported improvement were less likely to undergo an explant (P < 0.001) or to use an alternative treatment (P < 0.001), and they were also less likely to have diabetes (P=0.027) and had fewer follow up visits related to management of their device (P=0.001).

Conclusions: In a matched cohort of women with OAB who underwent an office PNE versus a staged approach to permanent implant placement, there was no difference in patient-reported symptom improvement within 12 months of implantation. The rate of device explant also did not differ between the groups.