The purpose of this study was to gather initial safety and efficacy data with the Optilume BPH Catheter System for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
Methods
A total of 80 men with moderate-to-severe LUTS secondary to BPH were enrolled and treated with the Optilume BPH Catheter System. Symptoms were evaluated using the International Prostate Symptom Score (IPSS) and Benign Prostatic Hyperplasia Impact Index (BPHII). Improvement in urinary flow and relief of obstruction was evaluated by way of peak urinary flow rate (Qmax) and postvoid residual urine volume (PVR). Subjects were prospectively queried for adverse events at each study visit, and relatedness to the study device were evaluated by the investigators, as well as centrally adjudicated by the study principal investigator.
Results
Previous reports of symptom improvement in this cohort were maintained through four-year followup, with a significant reduction in IPSS and IPSS quality of life maintained through four years (-12.1, -2.8, respectively). Clinically meaningful improvement in Qmax was maintained in the majority of subjects, with an average improvement from baseline of +5.6 mL/sec. No treatment-related adverse events were reported in the long-term followup period.
Conclusions
Long-term followup through four years for subjects treated with the Optilume BPH Catheter System indicates durable outcomes in symptom improvement and functional improvement in flow rate. These results indicate the unique mechanism of action for Optilume BPH successfully achieves an immediate mechanical effect that is maintained long-term through incorporation of paclitaxel to maintain patency.
The current Canadian Urological Association Journal (CUAJ) reports on the four-year results of the Optilume Everest study. The OptilumeÒ BPH Catheter System (Urotronic, Inc., Plymouth, MN, USA) is a novel minimally-invasive treatment option for males with lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO). It is a drug-coated balloon (DCB) dilatation system that follows a two-step mode of action. Firstly, with the mechanical dilatation of the balloon, an anterior commissurotomy is achieved after the catheter system has been positioned. Secondly, paclitaxel as an antiproliferative drug is released to prevent re-fusion of the adenoma. This straightforward approach can ideally be performed in an ambulatory setting under local anaesthesia.
In this feasibility study investigating the efficacy and safety of the device, the four-year results have indicated long-lasting improvements. Data were available for 59 patients out of the initial 80 patients included in the study. Clinical response as determined by changes in the International Prostate Symptom Score (IPSS) was maintained in 78% of patients with an average improvement of 12.1 points. Almost 2/3rds of the overall improvement was reported for voiding symptoms. Reduction in quality of life was sustained through four years with -2,8 points. The average increase of Qmax of 5,6 ml/sec was still observed after the four years follow-up. The safety profile was favourable. The retreatment rate was low with 1.3%. No relevant impairment of sexual function including erectile and ejaculatory function was observed after four years. This first impression is quite promising. Nevertheless, the one-year results reported treatment-related adverse events like haematuria (15%), post-procedural urinary retention (13,8%) and urinary incontinence (13,8%). The majority of these events (64%) occurred within the first three months after procedure. These safety concerns need to be acknowledged. Obvious limitations of the Everest study are the small sample size and the lack of a control arm. However, the benefits of the device were recently confirmed with the two-year results of the randomised, sham-controlled Pinnacle study.
Optilume appears to be a promising new kid on the block among the minimally-invasive treatment modalities, which might bridge the gap between medication and the ablative techniques like TURP or laser-based transurethral enucleation. Further studies are warranted to determine the true value of Optilume. Currently, the data on the comparison with established ablative procedures is missing.