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NEUROLOGY & FEMALE
UROLOGY
The
adjustable continence therapy system for recurrent female stress urinary
incontinence: 1-year results of the North America Clinical Study Group
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.
- Materials
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.
Reference
1. Darson MF, Malizia AA, Barrett DM: Periurethral injection of the genitourinary
spheroidal membrane. J Endourol. 1996; 10: 283-6.
Dr. Steven P. Petrou
Professor of Urology, Associate Dean
Mayo School of Graduate Medical Education
Jacksonville, Florida, USA
E-mail: petrou.steven@mayo.edu
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