Prostate Adjustable Continence Therapy (ProAct) Is A Safe And Effective Treatment For Post Radical Prostatectomy Incontinence

UroToday.com - Urinary incontinence after radical prostatectomy may affect 3-8% of patients and can have a significant negative impact on a patient's quality of life. Although the artificial urinary sphincter is considered the "gold standard" treatment for post prostatectomy incontinence, not all patients are candidates or wish to undergo this procedure. Some will opt for an alternative such as the male sling or periurethral bulking agent. Trigo-Roch and colleagues from Sao Paulo, Brazil examined the safety and efficacy of a new prosthesis the Prostate Adjustable Continence Therapy (ProAct; Uromedica, Plymouth, Minn) for the treatment of post prostatectomy incontinence.

This system consists of two balloons placed para-urethrally just beneath the bladder neck. There is a titanium port, which is placed in the scrotum, connected to each of the balloons that allow postoperative adjustment of the balloon volumes. They studied 25 patients with post radical prostatectomy incontinence. The device was placed under anesthesia through a perineal incision. With the help of fluoroscopy the pelvic floor is perforated and the region lateral to the urethra in the area of the bladder neck is dilated to create room for the balloon. A radio-opaque marker on the balloon tip allows identification of the exact position of the balloon. Once in the proper place, 1.5-2.0 ml of x-ray contrast and sterile water is injected into the balloon. Operative time was 22-58 minutes. 2 bladder perforations occurred at the time of placement, and these were treated with catheter drainage for 3 days. There were no other significant complications.

Of the 25 patients undergoing the procedure, 23 were evaluated (1 was lost to follow-up and 1 died). Pad count decreased from 4.76 ± 1.71 to 1.83 ± 1.58. Mean quality of life questionnaire (IQOL) scores improved from 63.04 ± 20.42 to 82.59 ± 15.24. There was also an increase in Valsalva leak point pressure after ProAct treatment from 48.7±25.37 cm H2O to 84.1 ± 33.5 cm H2O. Overall 8/23 (35%) were not satisfied with their treatment or had no significant change. The average number of postoperative adjustments performed in the outpatient setting was 4.6. 17.3% of the patients required revision (2 were for reimplantation of a single balloon after unintended bladder perforation, 1 was for a leaking balloon, 1 was for removal for erosion of injection port through the scrotal skin). Mean follow up was 22. 4 months (range 6-48 months).

The authors conclude that ProAct periurethral implant is a safe and effective alternative for the treatment of post radical prostatectomy incontinence. In those who failed or were not satisfied after ProAct treatment and went on the artificial urinary sphincter placement, the removal of the balloons were performed at the same setting and did not increase the difficulty of the procedure. This may add another treatment option for this difficult situation, however as the authors point out, larger series with longer follow up will be needed to determine its viability.

By M. Louis Moy, MD

Reference:
Urology 2006; 67: 965-969
Link Here.
Trigo-Rocha F, Gomes CM, Pompeo AC, Lucon AM, Arap S

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