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Mini-sling – New Minimally Invasive One-incision Sling for Treatment of Female SUI
needle is then placed into the dissected tunnel and directed towards the
Figure 3: Placement of the MiniArc Needle in a Bony Pelvis
obturator space at approximately a 45º angle. This is similar to the
‘hammock’ position of the Monarc TOT sling (see Figure 3). The needle
tip is directed towards the position in the groin where the TOT sling
incision would be made. Once the pelvic sidewall is penetrated, i.e. the
obturator fascia and muscle, the needle is advanced until the mid-point
of the sling is at the mid-urethra or just beyond. The sling tip should not
penetrate the obturator membrane. The needle is then easily removed
simply by sliding it back out of the fixating tip. Due to the tip’s design,
the sling does not move while disengaging the needle from the sling. The
other side is then completed in an identical fashion. The needle is
slowly advanced into the obturator muscle until a tension-free
adjustment is completed under the mid-urethra. The design of the
self-fixating tip and curved needle provide the surgeon with excellent
control when advancing the needle, allowing them to obtain precise
tension-free adjustment under the mid-urethra (see Figure 4). It is
recommended that the sling is placed flat against the urethra using a
Note the direction of the needle is towards the obturator space; this will place the sling in a
haemostat or similar instrument to help guide appropriate tensioning
‘hammock position’, which is the same position as the transobturator (TOT) sling.
without overtightening the sling.
Copyright: American Medical Systems, reproduced with permission.
Figure 4: MiniArc Sling in Position with the Self-fixating Tip in
If the patient is under MAC or local anaesthesia, a cough test for
Place in the Obturator Internus Muscle
adjustment of the sling can be completed. The bladder is filled with
250cc of fluid prior to the second side of the sling being placed. The
second side of the sling is then advanced into the sidewall, the needle
is left on the self-fixating tip and the patient is asked to cough. The
needle is then sequentially advanced into the obturator internus muscle
until there is no longer any leakage with cough. The vaginal epithelium
is then closed with absorbable sutures. Cystoscopy is left to the
discretion of the surgeon.
Clinical Results of MiniArc Sling
The results with the MiniArc sling were encouraging in the first clinical
trial to date. Our centre is leading a multicentre, retrospective study
with four other centres in the US to evaluate the first 60 patients
implanted with the MiniArc sling. Twelve-week follow-up has been
completed on 59 of 60 patients. Procedural results can be seen in Table
Copyright American Medical Systems, reproduced with permission.
1. The average procedure time has been only seven minutes, and blood
loss has been minimal. There were no intra-operative complications
Table 1: MiniArc Procedural Parameters
reported, including no incidence of bladder or urethra injury due to the
sling procedure. There have been no reports of pain, mesh extrusions Total Population, number Hospital Setting
or urinary obstructions requiring dilation, loosening or release of the
Subjects implanted with MiniArc, n (%) 60 (100%)
sling post-operatively. None of the self-fixating tips could be palpated
Procedure time (minutes)
Mean ± standard deviation 7±3.4
on vaginal exam. Only two of 60 patients required a catheter (for more
Range Minimum: 4, maximum: 20
than three days) and both were voiding normally by day 10.
Estimated blood loss (ml)
Mean ± standard deviation 27±16
Preliminary results have shown an objective cure of 92% in patients
Range Minimum: 10, maximum: 80
who underwent cough stress test on follow-up exam, with 46 of 50 number/Number (%)
patients tested having negative cough stress test (250cc in bladder).
Physician assessment of sling tension
The overall cure rate utilising objective testing in combination with
Loose 0/60 (0%)
physician and patient subjective assessment of cure was 93.2% (55 of
Standard 44/60 (73.3%)
Snug 16/60 (26.7%)
59 patients considered cured of SUI symptoms). The subjective cure
Subjects treated with concomitant procedure 40/60 (66.7%)
rate for SUI was 94.5% (Urinary Distress Impact [UDI]-6 score of 0 or
Cystocele repair 20/60*
1). Urinary urgency and frequency symptoms were significantly present
Rectocele repair 25/60*
in 66% of patients pre-operatively and in only 9.1% of patients post- Enterocele repair 3/60*
operatively. Patient quality of life was also significantly improved after
Uterine prolapse repair 7/60*
MiniArc sling placement, with quality of life scores (Incontinence
Other 24/60*
Impact Questionnaire [IIQ]-7 and UDI-6) showing statistically significant
Subjects with MiniArc implant complications 0/60 (0%)
improvement on both assessment questionnaires.
n = 60. * Some patients had multiple prolapse repairs during one concomitant procedure.
EUROPEAN UROLOGICAL REVIEW 79
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