First Report

U.S. Patient and Clinician Experiences With the inFlow™ Urinary Prosthesis for Permanent Urinary Retention in Women

Leanne Schimke, MSN, FNP-C, CRNP, CUNP; Kevin M. Connolly

Disclosures

Urol Nurs. 2020;40(2):61-73. 

In This Article

Clinician Experience

Clinical Case Studies Reported by Author Leanne Schimke, CRNP, CUNP

The inFlow device intrigued me as a urology clinician because it provided another option for my female women with PUR. I have used the device in my office for the past two years with a total of six women. In terms of choosing the appropriate patient to utilize the device, there was a learning curve. The following is my personal experience using the device with my women.

Three women have successfully used the device, and two continue to use it; the third woman is since deceased but used the device until her death. All three women have been unanimous in stating the device has been amazing and has greatly improved their quality of life. All three women were unable to perform CIC. Prior to using the inFlow device, two of the women required an indwelling catheter, and the other woman relied on her daughter, who worked full-time, to perform intermittent catheterization. These three women are my success stories.

However, the other three women were unable to utilize the inFlow device long-term. In evaluating why these women were unsuccessful, I have determined it was due to inadequately evaluating their emotional and physical readiness, as well as failing to ensure an appropriate home support system. A.S. (not patient's real initials) had a chronic indwelling catheter and was trialed with the inFlow. Although the inFlow device worked with her, she did not have the hand strength to keep the Activator button depressed during urination. A.S. lived with a family member; however, the family member was unable to help her master the inFlow device, so ultimately, after a week with multiple office visits to assess and confirm the device's functionality, the device was removed. Despite it not initially working for her, she stated it was wonderful not having an indwelling catheter with a urinary bag.

B.K. (not patient's real initials) had an indwelling catheter because she was unable to perform CIC, and no one in her family could do intermittent catheterization. She had problems with bladder spasms and experienced pain with the indwelling catheter. Physically, B.K. was an appropriate candidate; however, she developed increased stress regarding the device. She would use the Activator every hour to empty her bladder despite being educated to wait at least 90 minutes before voiding, which would allow the bladder to fill. Unfortunately, due to anxiety and increased stress level with the device, she requested to have it removed.

T.J. (not patient's real initials) originally had issues with frequency and urge incontinence, for which she had also undergone bladder botulinum toxin A injection, which caused long-term urinary retention (greater than three months). T.J. was unable to perform CIC and needed to rely on a family member to do so. Unfortunately, due to work schedules, CIC could not be performed in a timely fashion. Physically, T.J. was able to correctly use the Activator to empty her bladder; however, she did not want to use it at her place of work. She became incontinent as a result of not emptying her bladder. At this point, I recommended that we discontinue use of the device.

The takeaway from my experience is that to utilize the inFlow, women must be fully assessed in relation to cognition and the ability to follow directions. Moreover, physical strength should be assessed as well as the dexterity of the hands, which are needed to correctly operate the Activator. Emotional readiness should also be assessed (regarding the performing of a new procedure), and the woman's motivation and ability to empty the bladder every three to four hours while awake should be considered. In addition, it is also very helpful to have someone at home to provide guidance and emotional support.

Regarding issues of encrustation, UTIs, and decreased quality of life with current treatments mentioned earlier, my experience supports the claims of a reduced UTI rate because of the six women, only one has required antibiotics for one UTI. There have been no issues with encrustation. All women reported an improved quality of life. One woman stated she was able to go back to playing weekly games of bridge with her friends without fearing she smelled of urine. This woman stated that prior to inFlow, she had become reclusive (not doing the things she had previously done) due to the indwelling catheter.

The major drawback to the inFlow is that it is not being reimbursed by medical insurance; therefore, all of my female patients are on compassionate use. Currently, no U.S. patient has been charged for the inflow; all have been supplied on a compassionate use basis. The MSRP is $495 per device, but the reimbursement cost will be determined by CMS, and facilities themselves are likely to set pricing. However, pricing is thought to be comparable to Medicare's current reimbursement for intermittent catheters. Due to it not being covered by Medicare at this time, I have been unable to start new women on the device.

Insertion of the device is straightforward and easily done, but the introducer does require thumb strength to push, until the flanges spread. When the women come into the office to have it changed, they are instructed to not empty the bladder for 2 to 3 hours prior so they can activate the new inFlow device while on a commode to assure it is correctly working before they leave my office. Women need to be aware that the Activator is a very strong magnet, so it must be kept away from credit cards or hotel room keys; it is strongly attracted to metal, so keys, stethoscopes, and metal doors can all become attached to the Activator. Currently, there is a travel shield being developed by the company to help with this issue.

processing....