Myogenic bladder dysfunction and ureteral obstruction discovered in an adult patient with neurofibromatosis type 1: A case report.

We present a case of a 44-year-old male with cutaneous manifestations of neurofibromatosis type 1 presenting with long-standing urologic symptoms of uncertain etiology including urinary retention from myogenic bladder failure, chronic kidney disease with evidence of bilateral ureteral obstruction and presenting signs of an obstructing left ureterocele. This patient had a complete urologic evaluation and underwent ileocecocystoplasty with a continent catheterizable channel and bilateral ureteral reimplantation. Surgical excision of a left ureteral mound of tissue demonstrated the presence of a neurofibroma involving the bladder that led to obstruction. To our knowledge, this is the first report of such a presentation.

Digital Innovation in Medicinal Product Regulatory Submission, Review, and Approvals to Create a Dynamic Regulatory Ecosystem-Are We Ready for a Revolution?

The pace of scientific progress over the past several decades within the biological, drug development, and the digital realm has been remarkable. The'omics revolution has enabled a better understanding of the biological basis of disease, unlocking the possibility of new products such as gene and cell therapies which offer novel patient centric solutions. Innovative approaches to clinical trial designs promise greater efficiency, and in recent years, scientific collaborations, and consortia have been developing novel approaches to leverage new sources of evidence such as real-world data, patient experience data, and biomarker data. Alongside this there have been great strides in digital innovation. Cloud computing has become mainstream and the internet of things and blockchain technology have become a reality. These examples of transformation stand in sharp contrast to the current inefficient approach for regulatory submission, review, and approval of medicinal products. This process has not fundamentally changed since the beginning of medicine regulation in the late 1960s. Fortunately, progressive initiatives are emerging that will enrich and streamline regulatory decision making and deliver patient centric therapies, if they are successful in transforming the current transactional construct and harnessing scientific and technological advances. Such a radical transformation will not be simple for both regulatory authorities and company sponsors, nor will progress be linear. We examine the shortcomings of the current system with its entrenched and variable business processes, offer examples of progress as catalysts for change, and make the case for a new cloud based model. To optimize navigation toward this reality we identify implications and regulatory design questions which must be addressed. We conclude that a new model is possible and is slowly emerging through cumulative change initiatives that question, challenge, and redesign best practices, roles, and responsibilities, and that this must be combined with adaptation of behaviors and acquisition of new skills.

Needle in a haystack: Robotic removal of a retroperitoneal wire.

Retroperitoneal foreign bodies are rare indications for exploratory surgery. We present a case of a 19-year-old male with abdominal pain after a fall who was found to have a linear metallic object adjacent to the right ureter and inferior vena cava. Given the patient's pain and discomfort, he elected for robotic exploration of the retroperitoneum, which was carried out successfully with the Da Vinci Si® robot. This case demonstrates the feasibility of robotic retroperitoneal exploration and foreign body retrieval for a very small object.