UroToday - Post radical prostatectomy urinary incontinence represents a serious complication of the surgery, significantly compromising a patient's quality of life. About 6% of patients undergoing radical prostatectomy will need surgical treatment for their incontinence. A new prosthesis, the Adjustable Continence Therapy (ProACT) device, was developed to give an alternative to the current options of injectable bulking agents, sling procedures, and the artificial urinary sphincter.

The ProACT involves the insertion of two balloons periurethrally, one on each side of the urethra just beneath the bladder neck to increase its resistance. The device is placed perineally after puncturing of the pelvic floor and developing a space with blunt dissection and fluoroscopic guidance to place the contrast filled balloon. The novel difference with this device is the ability to adjust the tightness of the urethral occlusion by altering the amount to fluid in each balloon via a titanium port connector that can be accessed via a percutaneous injection in the scrotum. A recent study to evaluate the efficacy and safety of the device was performed by F. Trigo-Rocha and colleagues from Sao Paulo Brazil. The study is published in the May 2006 issue of Urology.

In this study, 23 patients suffering from post-prostatectomy incontinence underwent insertion of the ProAct device over a 4 year period. The preoperative and postoperative evaluation included pad count, Valsalva leak point pressure determinations, and Incontinence Quality-of-Life scores. The follow-up period was 6 to 48 months with a mean of 22.4 months.

Analysis of the efficacy showed significant improvements in pad count, Incontinence Quality-of-Life scores, and Valsalva leak point pressures from baseline (P < 0.05). Overall, 15 (65.2%) of patients were continent using 0-1 pad daily and satisfied, 3 (13%) were improved but unsatisfied, and 5 (22%) did not have any improvement. The daily pad count dropped from 4.76 to 1.83 pad daily, the Valsalva leak point pressure increased from 48.76 cm H2O to 84.1 cm H2O. Balloon adjustments were performed in all patients to achieve continence. The average number of adjustments was 4.6 (range 1 to 7) all of which were done in an outpatient setting and in the first 6 months after placement. The final balloon volume ranged from 2.0 to 7.0 mL (mean 3.5 mL). Revision surgery was required in 4 (17%) of 23 patients. Mean operative time was a mean of 35.4 minutes. No significant bleeding or anesthetic complications were observed in any patient.

The ProACT device offers another option for patients suffering from the debilitating problem of post radical prostatectomy incontinence. The device gives a good degree of patient satisfaction and a low complication rate. The ability to adjust urethral compression based on symptoms is truly novel compared to existing surgical options.

By Michael J. Metro, M.D.

Reference:
Urology. 2006 May; 67(5):965-69
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