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MACROPLASTIQUE
INJECTION IN 20 WOMEN WITH INTRINSIC SPHINCTER DEFICIENCY AIM OF
STUDY
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Authors:
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S Salvatore, S Scalambrino,
S Gallazzi, M Vignali, R Milani
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Institution:
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Azienda Ospedaliera San
Gerardo di Monza, Università di Milano Bicocca, Italy
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AIM OF STUDY
According to Blaivas classification intrinsic sphincter deficiency (ISD) is
defined when genuine stress incontinence is associated with a fixed urethra
and a maximum closure pressure less than 20cmH2O on urethral pressure profilometry.
Women suffering of such condition are reported to have a lower success rate
when a Burch colposuspension is performed. Amongst the available treatments
for ISD, the intra- or para-urethral injection of different materials (gax collagen,
autologous fat, macroplastique etc) has been reported. Macroplastique has the
advantage to be readily available, it does not need to be stored in a fridge,
it doesn't require a skin test and, theoretically, it should not be reabsorbed
like the other materials. The aim of this study is to evaluate the success and
the complications rate of macroplastique as a treatment of women with ISD.
METHODS
In this study we only included women with genuine stress incontinence on cystometry
with a maximum urethral closure pressure < 20cmH2O and a fixed urethra demonstrated
with a < Q-Tip < 30°. All this women underwent an intraurethral injection of
Macroplastique, which was repeated after some time up to 3 times when required.
The intraurethral injection was performed cystoscopically using a 30° lenses
under local anaesthetic. Each time the injection was performed in 3 different
points at the level of the bladder neck (Hrs 3-6-9). No catheter was placed
after injection and each patient was invited to void spontaneously after maximum
of 4 hours. A post-void residual was checked with ultrasound and a catheterisation
was performed when needed. All women were reassessed both subjectively and urodynamically
at 3, 6, 9 and 12 months. In case of failure women were re-booked for a repeat
injection up to 3 times. All the data were then stored into a specifically designed
database and analysed.
RESULTS
From 1996 to 1999 we included 20 women with a mean age of 69 years (range 52-87
yrs). Preoperatively five women used no more than 2 pads/day, 9 used 3-4 pads/day
and 6 women more than 5 pads/day. The mean maximum urethral closure pressure
was 16.5cmH2O (SD ± 7.4 cmH2O) and the mean functional urethral length was 19.5mm
(SD ± 3.5mm). Five women had a previous retropubic surgery, 5 vaginal surgery,
1 had a vulvectomy, 3 pelvic radiotherapy whereas 7 had not any previous therapy.
A total of 32 macroplastique implants were performed with a mean amount/implant
of 5.3ml (range 2.5-10ml) and a mean amount/patient of 8.25ml (range 2.5-17.5ml).
After a mean follow-up of 7 months (range 3-13 months) all women were reassessed.
Seven women (35%) were subjectively cured and 6 (30%) objectively, eight women
(40%) were improved and 5 (25%) the same. Two women (10%) complained of de-novo
detrusor instability and no one had voiding difficulties.
CONCLUSION
In this study we found that only 35% of women with intrinsic sphincter deficiency
can be cured. However when also improvement is considered the rate of success
increases up to 75%. This is reasonably good result, especially considering
this group of selected women, which are generally considered at high risk for
surgical failure. A longer assessment for efficacy is needed to confirm these
data.