A Novel Transurethral Cryotherapy Catheter System to Treat Benign Prostate Hyperplasia

Abstract Benign prostate hyperplasiaBPHis a chronic and highly prevalent medical condition in aging menApproximatelyof men agedyears are affected by BPH and associated lower urinary tract symptomsLUTSa progressive and chronic medical condition that drastically impairs quality of lifeWhile first line drug therapies successfully impede further enlargement of the prostate glandthey only provide modest symptom relief and are associated with a prominent side effect profile that directly impacts quality of lifeAs a resultsurgical intervention is necessary inof all men afflicted with BPHmaking it one of the most common procedures among elderly men with estimated annual direct costs of $B in the U SaloneTransurethral resection of the prostateTURPis effective for improving LUTSbut the procedure is invasive and has a prominent side effect profileWhile less invasive surgical techniques for BPH have reduced the complications associated with TURPthese techniques have limited efficacy and or poor long term durabilityEven the Prostatic Urethral LiftPULprocedurea promising new therapyhas an early indication of poor long term LUTS symptom reliefTo address the need for a minimally invasive approach that has robust long term effectiveness and minimal comorbiditiesTheraNova has developed the TUCT Cathetera transurethral cryotherapyTUCTcatheter system for BPH treatmentThe TUCT Catheter is comprised of a urinary catheter balloon system that provides uniform delivery of cryotherapy to both lateral lobes of the prostate through a single approach and without the need for repositioningThe goals of this Phase I proposal are to optimize the TUCT Catheter system parameters for cryotherapy treatment and assess safety and effectiveness in a pilot preclinical studyIn Specific Aimwe will test the TUCT Catheter in a benchtop model to optimize system parameters for achieving the desired cryotherapy doseThe optimized system will be used in Specific Aimto determine the effectiveness of the TUCT Catheter cryotherapy treatmentrelative to a sham control treatmentto induce cell death of prostate cells in an animal modelWe will also evaluate urethral damage and bladder function one week after treatmentThe data obtained through this proposal will be used to demonstrate proof of concept for this novel cryotherapeutic technology for BPHThese data will also be used to support a Phase II submissionwhich will include a pivotal pre clinical study and a pilot clinical study to determine clinical effectiveness of the TUCT Catheter for the treatment of BPH Narrative Benign prostate hyperplasiaBPHis a chronic and highly prevalent disease among aging men that refers to the nonmalignant growth of the prostate glandCommercially available therapies for BPH can be effectivehowever they have undesirable side effect profiles or limited durabilityWe propose a novelminimally invasivetransurethral cryotherapy catheter system for treatment of BPH