Pacey Cuff™: Clinical Follow Up

Cystoscopy Study - Eleven Months

Index Patient

Clinical Summary:

The Pacey Cuff™ has been used by a post-radiation therapy patient who had Palladium Brachytherapy carried out by Dr. Gregory Merrick of Schiffler Hospital in Wheeling, West Virginia in 2001. Then 50 Gray External Beam Radiotherapy was delivered at CCABC using a Linac linear accelerator to complete the treatment. The bladder outlet developed calcification and complete obstruction in 2008 when surgical relief resulted in incontinence.

Treatment with an AMS 800 device was effective for two years with one replacement. The device was removed afterwards. Radiation induced vascular changes to the base of the bladder, resulting in atrophic changes at the level of the upper urethra.

Pacey Cuff™ treatment started in early December 2016 and continued through the development period of the device. On 275 days of this 310-day period, the device was in constant twenty-four-hour use. Initial cystoscopy showed excellent healing of former surgical approaches to the urethra. The cystoscopy follow-up was completed November 20, 2017 and showed no negative impact on the urethra resulting from intense usage.

The plan to follow this sentinel case will include cystoscopic examination to ensure that any urethritis will be seen and managed. The current Pacey Cuff™ has undergone design changes to make it more tissue friendly, and its excellent record is likely to continue as more follow-up is recorded.