Kidney stones represent a significant health concern both domestically and worldwide, with incidence rates increasing over the past three decades due to the combination of dietary habits and sedentary lifestyle. Ureteral stents are an important tool to support kidney stone management, but for the past 50 years have not advanced beyond the traditional nondegradable single- or double-curl design requiring a secondary procedure for removal. Pain and discomfort is prevalent, reported for up to 80% of patients, as are other patient inconveniences, such as urinary incontinence. Advances such as lubricious coatings and higher compliance materials have not significantly addressed these concerns and unfortunately, it is established that these traditional stents are a direct cause of pain and discomfort while (1) the stent is in place, and (2) as a result of the secondary stent removal procedure. Due to pain, nearly 4 in 10 patients use opioid medications, a far higher rate than that of non-stented patients. These disadvantages demonstrate a need for new stent concepts. ADVA-Tec, Inc. has developed Uriprene®, a degradable ureteral stent designed to temporarily support drainage from the kidney to the bladder as a part of kidney stone management. Uriprene is a composite tubular structure that provides drainage like other ureteral stents, but softens after implantation and ultimately degrades into compliant pieces that void naturally with urination. An 8-patient pilot clinical study, as well as several pre-clinical evaluations, has confirmed the safety of Uriprene, and preliminary evaluations support the ability of Uriprene to address stent pain and discomfort while in place; Uriprene also eliminates the need for a secondary removal procedure, another significant contributor to pain and discomfort. The objective of this SBIR proposal is to demonstrate the safety, efficacy, incontinence rates, and pain response of Uriprene through a single arm multi-site study. This will be achieved through objective outcome measures such as laboratory and radiographic assessments, including recorded usage of pain medications, as well as through subjective measures such as patient-scored pain through a validated questionnaire. This study will follow 87 patients through the 30-day stent degradation and self-elimination window, and up to 90 days post- surgery as necessary. Stent performance will be statistically evaluated against published historical controls that represent the standard of care. Prior communication with FDA confirms our regulatory path, and successful completion of this study will provide the necessary support to submit the Uriprene degradable stent for regulatory clearance, thereby translating this important device advance to market.
Public Health Relevance Statement: PROJECT NARRATIVE Over the past 50 years, ureteral stenting has gained widespread acceptance to reduce the risk of significant harm from kidney stone management procedures; however, side effects are common with up to 80% of patients experiencing pain and discomfort as a direct result of the stent while implanted and due to the required secondary removal procedure leading to prevalent use of opioids. Incontinence is also a currently accepted result due to stenting. This SBIR proposal aims to validate, through a clinical trial, performance improvements associated with Uriprene®, a degradable ureteral stent, including objective and subjective evaluation of safety, efficacy, pain and a reduction in anticipated incontinence rates. Successful completion of this work will directly translate to a marketed product through support of the 510(k) regulatory pathway and provide scientific evidence to support the benefits of the product for broad adoption.
Project Terms: Adoption; Adult; 21+ years old; Adult Human; adulthood; Analgesics; Analgesic Agents; Analgesic Drugs; Analgesic Preparation; Anodynes; Antinociceptive Agents; Antinociceptive Drugs; pain killer; pain medication; pain reliever; painkiller; Animals; Bladder; Bladder Urinary System; urinary bladder; Clinical Research; Clinical Study; Clinical Trials; Communication; Disadvantaged; Disease; Disorder; Drainage procedure; Drainage; Feedback; Flank Pain; Health; Human; Modern Man; Hydronephrosis; Incidence; Incontinence; Interview; Kidney; Kidney Urinary System; renal; Kidney Calculi; Kidney Stones; Renal Calculi; Renal Stone; Laboratories; Literature; Pain; Painful; Legal patent; Patents; Patients; Publishing; Quality of life; QOL; Questionnaires; Radiology Specialty; General Radiology; Radiology; Risk; Safety; Stents; Technology; Translating; Urinary Incontinence; Urination; micturition; Urine; Urine Urinary System; Work; Diagnostic radiologic examination; Conventional X-Ray; Diagnostic Radiology; Diagnostic X-Ray; Diagnostic X-Ray Radiology; Radiography; Roentgenography; X-Ray Imaging; X-Ray Medical Imaging; Xray imaging; Xray medical imaging; conventional Xray; diagnostic Xray; diagnostic Xray radiology; Measures; Dietary Habits; eating habit; Diet Habits; Outcome Measure; base; improved; Procedures; Ureteroscopy; Site; Clinical; Medical; Evaluation; Opiates; Opioid; Tubular; Tubular formation; tool; Knowledge; Severities; Event; Source; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; Operative Surgical Procedures; meetings; experience; Performance; Structure; Devices; Reporting; Abscission; Extirpation; Removal; Surgical Removal; resection; Excision; response; Adverse Experience; Adverse event; Intervention Strategies; interventional strategy; Intervention; preventing; prevent; Address; Symptoms; Regulatory Pathway; Clinical Evaluation; Clinical Testing; clinical test; research clinical testing; SBIR; Small Business Innovation Research; Small Business Innovation Research Grant; Validation; Monitor; Active Follow-up; active followup; follow up; followed up; followup; follow-up; imaging; Image; preclinical; pre-clinical; designing; design; clinical site; clinical research site; Outcome; Population; prospective; Implant; implantation; stem; standard of care; pre-clinical evaluation; preclinical evaluation; licit opioid; opiate medication; opioid medication; prescribed opiate; prescribed opioid; prescription opiate; prescription opioid; arm; Sedentary behavior; Sedentary life-style; sedentary lifestyle; predictive outcomes; predictors of outcomes; outcome prediction; improved outcome; opiate consumption; opiate drug use; opiate intake; opiate use; opioid consumption; opioid drug use; opioid intake; opioid use; recruit; pain score; side effect; adverse event monitoring
