V02-07: Utilizing a novel bladder model to evaluate the ProSac: facilitating safe and efficient tissue morcellation during HoLEP
Morcellation of prostate adenoma after holmium laser enucleation (HoLEP) is both time consuming and potentially morbid. We have previously described a novel polyethylene sack (ProSac) that was shown to improve the morcellation efficiency of simulated prostate adenoma. We sought to develop a model that better represented the human bladder and conduct further testing of morcellation safety and efficacy with the ProSac.
Using tissue-mimicking, platinum-cured silicone we have developed a bladder model that accurately approximates bladder volume and compliance. The model has dual-layered silicone to mimic bladder urothelium and underlying detrusor. Heat-fixed chicken breast was used to mimic enucleated prostatic adenoma. Approximately 15 grams of tissue was placed in the bladder model and 5 trials of morcellation were performed both with the device (study arm) and without the device (control arm). Morcellated tissue was removed from the filter, desiccated, and weighed after each run to establish morcellation efficiency. Following all runs, the models were disassembled and total mucosal injuries were counted by visual inspection. Injury per minute of morcellation was calculated for each study arm. A T-Test was used for statistical analysis.
The device was able to capture up to 30 grams of tissue with good closure while maintaining good distention and visualization during morcellation. Morcellation efficiency with the device was 4.6 g/min, while efficiency without the device was 2.6 g/min (p = 0.03). This represents a 77% increase in morcellation efficiency with the ProSac (Table 1). Without the device, a bladder mucosal injury occurred every 8.1 minutes of morcellation time. No bladder mucosa injuries occurred with the device.
The ProSac is a novel device that can provide additional safety during morcellation after HoLEP. In this study, we develop a silicone-based bladder model to approximate human bladder tissue and performed testing with heat fixed chicken breast. The ProSac achieved a clinically and statistically significant improvement in morcellation efficiency. With no bladder mucosa injuries, this device demonstrated improved safety over the control arm. Further in vitro and in vivo testing is needed to validate this device.