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Biodegradable ring-shaped implantable device for intravesical therapy of bladder disorders.

ABSTRACT: Intravesical instillation is an efficient drug delivery route for the local treatment of various urological conditions. Nevertheless, intravesical instillation is associated with several challenges, including pain, urological infection, and frequent clinic visits for catheterization; these difficulties support the need for a simple and easy intravesical drug delivery platform. Here, we propose a novel biodegradable intravesical device capable of long-term, local drug delivery without a retrieval procedure. The intravesical device is composed of drug encapsulating biodegradable polycaprolactone (PCL) microcapsules and connected by a bioabsorbable Polydioxanone (PDS) suture with NdFeB magnets in the end. The device is easily inserted into the bladder and forms a 'ring' shape optimized for maximal mechanical stability as informed by finite element analysis. In this study, inserted devices were retained in a swine model for 4 weeks. Using this device, we evaluated the system's capacity for delivery of lidocaine and resiquimod and demonstrated prolonged drug release. Moreover, a cost-effectiveness analysis supports device implementation compared to the standard of care. Our data support that this device can be a versatile drug delivery platform for urologic medications.

SUBMITTER: Kim H

PROVIDER: S-EPMC10485746 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Biodegradable ring-shaped implantable device for intravesical therapy of bladder disorders.

Kim Hyunjoon H Lee Seung Ho SH Wentworth Adam A Babaee Sahab S Wong Kaitlyn K Collins Joy E JE Chu Jacqueline J Ishida Keiko K Kuosmanen Johannes J Jenkins Joshua J Hess Kaitlyn K Lopes Aaron A Morimoto Joshua J Wan Qianqian Q Potdar Shaunak V SV McNally Ronan R Tov Caitlynn C Kim Na Yoon NY Hayward Alison A Wollin Daniel D Langer Robert R Traverso Giovanni G

Biomaterials 20220817

Intravesical instillation is an efficient drug delivery route for the local treatment of various urological conditions. Nevertheless, intravesical instillation is associated with several challenges, including pain, urological infection, and frequent clinic visits for catheterization; these difficulties support the need for a simple and easy intravesical drug delivery platform. Here, we propose a novel biodegradable intravesical device capable of long-term, local drug delivery without a retrieval ...[more]

PMID: 36030104

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Project description:Traditional urodynamics have poor correlation with urological symptoms. Ambulatory urodynamics may improve this correlation but the need for a transurethral catheter and the time-consuming nature of this examination limits its use. Therefore, the objective of this study was to develop a wireless real-time bladder pressure measurement device for repeated and prolonged-term measurement of bladder behavior in awake pigs. The Bladder Pill is an intravesical device with a pressure microsensor and a 3-dimensional inductive coupling coil for energy supply. A corresponding external coil provides wireless power transmission and real-time communication of bladder pressure data. To test the correlation between the pressure data measured by the device and by standard methods, we compared static water column pressures with this device and water-filled urodynamic catheter systems. In vivo assessment of awake voiding by the pill was done by introducing the bladder pill into the bladder of Göttingen minipigs. An air-charged urodynamic catheter was introduced transurethrally as control for pressure measurements. The optimal physical configuration of the pill was investigated to maximize the containment in the bladder. We used two versions of external signal receivers (one waistband and one rectangular frame) to test the optimal external signal capture. Next to that, we performed short-term and medium-term comparative pressure studies. The in vitro static pressure measurement demonstrated a mean difference of less than 1 cm H2O between the methods. The optimal design of the pill for maximal retainment in the bladder proved to be a pigtail configuration. The bending of the device during bladder contractions caused offset of 2.7 +/- 1.4 cm H2O (mean +/- SD) on the pressure measurements. The rectangular frame performed signal capture during 5 consecutive voids with a good correlation of the pressure measurements. The device can be inserted through the urethra and is retrieved using string or endoscopic extraction. In conclusion, wireless long-term measurement of bladder pressure is demonstrated and yields comparable results to current available catheter methods of measurement in a pig model.

Project description:PurposeWe conducted a prospective pilot study to evaluate safety and feasibility of TraceIT, a resorbable radiopaque hydrogel, to improve image guidance for bladder cancer radiation therapy (RT).Methods and materialsPatients with muscle invasive bladder cancer receiving definitive RT were eligible. TraceIT was injected intravesically around the tumor bed during maximal transurethral resection of bladder tumor. The primary endpoint was the difference between radiation treatment planning margin on daily cone beam computed tomography based on alignment to TraceIT versus standard-of-care pelvic bone anatomy. The Van Herk margin formula was used to determine the optimal planning target volume margin. TraceIT visibility, recurrence rates, and survival were estimated by Kaplan-Meier method. Toxicity was measured by Common Terminology Criteria for Adverse Events version 4.03.ResultsThe trial was fully accrued and 15 patients were analyzed. TraceIT was injected in 4 sites/patient (range, 4-6). Overall, 94% (95% confidence interval [CI], 90%-98%) of injection sites were radiographically visible at RT initiation versus 71% (95% CI, 62%-81%) at RT completion. The median duration of radiographic visibility for injection sites was 106 days (95% CI, 104-113). Most patients were treated with a standard split-course approach with initial pelvic radiation fields, then midcourse repeat transurethral resection of bladder tumor followed by bladder tumor bed boost fields, and 14/15 received concurrent chemotherapy. Alignment to fiducials could allow for reduced planning target volume margins (0.67 vs 1.56 cm) for the initial phase of RT, but not for the boost (1.01 vs 0.96 cm). This allowed for improved target coverage (D95% 80%-83% to 91%-94%) for 2 patients retrospectively planned with both volumetric-modulated arc therapy and 3-dimensional conformal RT. At median follow-up of 22 months, no acute or late complications attributable to TraceIT placement occurred. No patients required salvage cystectomy.ConclusionsTraceIT intravesical fiducial placement is safe and feasible and may facilitate tumor bed delineation and targeting in patients undergoing RT for localized muscle invasive bladder cancer. Improved image guided treatment may facilitate strategies to improve local control and minimize toxicity.

Dataset Information

Biodegradable ring-shaped implantable device for intravesical therapy of bladder disorders.

Publications

Biodegradable ring-shaped implantable device for intravesical therapy of bladder disorders.

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