Prospective, multicenter study to evaluate performance and safety of a re-engineered temporary lead for InterStim™ therapy evaluation.

AIMS: The basic evaluation or percutaneous nerve evaluation (PNE) is a method to assess pre-implantation therapeutic response in patients considering sacral neuromodulation for the treatment of refractory overactive bladder. A new PNE lead with a more robust design and greater distensibility designed to reduce the possibility of lead migration has recently been introduced to the market. The aim of this prospective, multicenter, global, postmarket study was to evaluate the clinical performance and safety of the new InterStim PNE lead with the foramen needle. METHODS: Patients with overactive bladder were enrolled in this study. The primary objective of this study was to determine the proportion of subjects who demonstrated motor or sensory response(s) during lead placement using the InterStim PNE lead. Additional measures included the Patient Global Impression of Improvement (PGI-I), patient satisfaction at the end of therapy evaluation, and change in bladder symptoms from baseline to the end of therapy evaluation (1-week follow-up visit). RESULTS: One-hundred and ten subjects met the inclusion and exclusion criteria and underwent a lead implant procedure. Of those, 108 had a successful procedure and 107 completed the 1-week follow-up visit. Ninety-nine percent of subjects (109/110) had a motor or sensory response during needle placement (95% confidence interval [CI]: 95%-100%) and 97% of subjects (107/110) had a motor or sensory response during lead placement (95% CI: 92%-99%). The majority of subjects (88%, 95/108) reported their bladder condition was better at the follow-up visit compared to before the PNE implant procedure, as reported in PGI-I. Subjects reported being satisfied with how the therapy impacted their voiding symptoms (82%, 88/108) and that they would recommend this therapy (87%, 94/108) to other patients. Symptom improvement was demonstrated with urinary urge incontinence subjects having an average of 4.2 ± 3.4 urinary incontinence episodes/day at baseline and 2.2 ± 2.5 at follow-up, and urinary frequency subjects having an average of 12.5 ± 4.4 voids/day at baseline and 10.5 ± 4.3 voids/day at follow-up. Lead removal was deemed to be easy and safe by the implanting physician, with a total of three adverse device effects in 3/110 subjects. No event was categorized as serious and all were resolved without sequelae. CONCLUSIONS: The updated InterStim PNE lead with a more robust design and greater distensibility designed to reduce migration was shown to have a high rate of motor or sensory response during lead placement. Furthermore, subjects reported high rates of global improvements and amelioration of symptoms, and the lead was easy to remove with minimal morbidity.

Current process and outcomes of the surgical management of LUTS due to benign prostatic enlargement: how consistent are we? - results from the multi-institutional audit of surgical management of BPE (AuSuM BPE) in the United Kingdom.

OBJECTIVE: In view of changing landscape of surgical treatment for LUTS secondary to BPE, this audit was undertaken to assess key aspects of the processes and outcomes of the current interventional treatments for BPE, across different units in the UK. MATERIALS AND METHOD: A multi-institutional snapshot audit was conducted for patients undergoing interventions for LUTS/BPE over 8-week period. Using Delphi process two-part proforma was designed to capture data. RESULTS: 529 patients were included across 20 NHS trusts in England and Wales. Median age was 73 years. Indications for surgery were acute retention (47%) and LUTS (45%). 80% of patients had prior medical therapy. TURP formed the commonest procedure. 27% patients had <23 hour hospital stay. Immediate (21%) and delayed (18%) complications were Clavien-Dindo <2 category. High proportion of patients reported residual symptoms. Type and indication of surgery were significant predictor of complications, length of stay and failure of TWOC outcomes, on multivariate analyses. There were variations in departmental processes, 50% centres used PROMs. CONCLUSION: Monopolar TURP still remains the commonest intervention for BPE. Most departments are adopting newer technologies. The audit identified opportunities for development of consistent, effective and patient centric practices as well as need for large-scale focused studies.

The cost-effectiveness of sacral nerve stimulation (SNS) for the treatment of idiopathic medically refractory overactive bladder (wet) in the UK.

OBJECTIVE: To estimate the long-term cost-effectiveness of specialised treatment options for medically refractory idiopathic overactive bladder (OAB) wet. PATIENTS AND METHODS: The cost-effectiveness of competing treatment options for patients with medically refractory idiopathic OAB wet was estimated from the perspective of the National Health Service in the UK. We compared sacral nerve stimulation (SNS) with percutaneous nerve evaluation (PNE) or tined-lead evaluation (TLE) with optimal medical therapy (OMT), botulinum toxin type A (BoNT-A) injections, and percutaneous tibial nerve stimulation (PTNS). We used a Markov model with a 10-year time horizon for all treatment options with the exception of PTNS, which has a time horizon of 5 years. Costs and effects (measured as quality-adjusted life years) were calculated to derive incremental cost-effectiveness ratios (ICERs). Direct medical resources included are: device and drug acquisition costs, pre-procedure and procedure costs, and the cost of managing adverse events. Deterministic sensitivity analyses were performed to test robustness of results. RESULTS: At 5 years, SNS (PNE or TLE) was more effective and less costly than PTNS. Compared with OMT at 10 years, SNS (PNE or TLE) was more costly and more effective, and compared with BoNT-A, SNS PNE was less costly and more effective, and SNS TLE was more costly and more effective. Decreasing the BoNT-A dose from 150 to 100 IU marginally increased the 10 year ICERs for SNS TLE and PNE (SNS PNE was no longer dominant). However, both SNS options remained cost-effective. CONCLUSION: In the management of patients with idiopathic OAB wet, the results of this cost-utility analysis favours SNS (PNE or TLE) over PTNS or OMT, and the most efficient treatment strategy is SNS PNE over BoNT-A over a 10-year period.