UROLOGICAL SURVEY
Aboseif SR, Franke EI, Nash SD, Slutsky JN, Baum NH, Tu le M, Galloway NT, Pommerville PJ, Sutherland SE, Bresette JF
Department of Urology, Kaiser Permanente, Los Angeles, California, USA
J Urol. 2009; 181: 2187-91
PURPOSE: We determined the efficacy, safety, adjustability and technical feasibility of the adjustable continence therapy device (Uromedica, Plymouth, Minnesota) for the treatment of recurrent female stress urinary incontinence.
MATERIAL AND METHODS: Female patients with recurrent stress urinary incontinence were enrolled in the study and a defined set of exclusionary criteria were followed. Baseline and regular follow-up tests to determine eligibility, and to measure subjective and objective improvement were performed. A trocar was passed fluoroscopically and with digital vaginal guidance to the urethrovesical junction through small incisions between the labia majora and minora. The adjustable continence therapy device was delivered and the balloons were filled with isotonic contrast. The injection ports for balloon inflation were placed in a subcutaneous pocket in each labia majora. Device adjustments were performed percutaneously in the clinic postoperatively. An approved investigational device exemption Food and Drug Administration protocol was followed to record all adverse events.
RESULTS: A total of 162 subjects underwent implantation with 1 year of data available on 140. Mean Stamey score improved by 1 grade or more in 76.4% (107 of 140) of subjects. Improvement in the mean incontinence quality of life questionnaire score was noted at 36.5 to 70.7 (p < 0.001). Reductions in mean Urogenital Distress Inventory (60.3 to 33.4) and Incontinence Impact Questionnaire (54.4 to 23.4) scores also occurred (p < 0.001). Mean provocative pad weight decreased from 49.6 to 11.2 gm (p < 0.001). Of the patients 52% (67 of 130) were dry at 1 year (less than 2 gm on provocative pad weight testing) and 80% (102 of 126) were improved (greater than 50% reduction on provocative pad weight testing). Complications occurred in 24.4% (38 of 156) of patients. Explantation was required in 18.3% (28 of 153) of the patients during 1 year. In terms of the complications 96.0% were considered to be mild or moderate.
CONCLUSIONS: The Uromedica adjustable continence therapy device is an effective, simple, safe and minimally invasive treatment for recurrent female stress urinary incontinence. It can be easily adjusted percutaneously to enhance efficacy and complications are usually easily manageable. Explantation does not preclude later repeat implantation.
Editorial Comment
The authors describe a balloon system to provide support and urethral coaptation in those patients plagued with female stress incontinence. The authors describe a 52% dry rate at 1 year as well as an 80% improvement rate. Of the patients studied, approximately 18% required removal of the device. Of those cases that need explantation, 50% of the women still opted to be reimplanted within 12 months after the initial device removal. Presumably, secondary to position of the adjustment port, sexual activity was associated with a higher complication rate.
An interesting technology, which is not overly dissimilar to the genitourinary spheroidal membrane, which had its greatest degree of clinical exposure in the mid-1990s (1). Problems with the genitourinary spheroidal membrane at that time included the lack of ability for secondary and tertiary adjustments as well as the tendency of the device to float into non-therapeutic positions in the retropubic space. It seems that the adjustment port of this device, which is placed at the labia majora, may help anchor the support balloons and keep them from migrating to non-therapeutic positions as well as providing a method for adjustment. Perhaps these modifications will allow it to have a greater shelf life than that experienced by the genitourinary spheroidal membrane.
Dr. Steven P. Petrou
Professor of Urology, Associate Dean
Mayo School of Graduate Medical Education
Jacksonville, Florida, USA
E-mail: petrou.steven@mayo.edu
- 1. Darson MF, Malizia AA, Barrett DM: Periurethral injection of the genitourinary spheroidal membrane. J Endourol. 1996; 10: 283-6.
Neurology & Female Urology
Publication Dates
-
Publication in this collection
24 Aug 2009 -
Date of issue
June 2009
