Aims of Study:
The goal of this
study
is
to
evaluate
the
initial
operative
safety
and
short
and
intermediate
term
efficacy
of
radio
frequency
(RF)
bladder
neck
suspension
for
the
treatment
of
female
stress
urinary
incontinence
(SUI).
The
approach
reported
here
evaluated
a
minimally
invasive
technique
for
providing
support
to
the
urethrovesical
junction
utilizing
radio
frequency
induced
tissue
changes
without
the
use
of
implantable
materials,
sutures,
staples,
or
mesh.
A
similar
technique
is
used
by
orthopedic
surgeons
in
shoulder
and
spine
surgery
to
support
and
lift
other
anatomic
structures.
Methods:
Two parallel, independent,
prospective
IDE
approved,
multi-center
comparative
studies
of
RF
treatment
were
conducted
on
women
with
genuine
SUI
confirmed
by
objective
urodynamics.
Two
access
methods
were
used:
the
first
uses
a
standard
extraperitoneal
laparoscopic
(LP)
approach
and
the
second
a
bilateral
transvaginal
(TV)
approach. In both procedures, the endopelvic fascia (EPF) was visualized and
an
instrument
(SURx,
Inc.,
Pleasanton,
CA)
was
used
to
apply
the
low
power
RF
energy
directly
to
the
EPF.
The
EPF
was
observed
to
shrink
as
a
result
of
the
heat
generated
by
the
RF. Success and complication rates were noted and
compared
to
published
sources
to
determine
the
safety
profile
of
this
new
procedure.
Results:
Complication rates
were
noted
and
compared
to
the
American
Urological
Association
19971
report
on
surgical
options
for
incontinence.
Success
rates
were
determined
by
standard
urodynamics,
pad
usage,
voiding
diaries
and
patient
satisfaction
scores.
|
Complication/Risk
|
Retropubic Suspension1
|
Sling1
|
TV(N=26)
|
LP(N=105)
|
|
Intra-operative
(bladder,
urethra
perforation)
Transfusion
Retention
(longer
than
4
wks)
Comp.
Requiring
Surgery
Urgency
Wound
Comp.
UT
Infection
TOTAL
|
2%
2
5
2
11
7
13
42%
|
3%
4
8
3
7
9
12
46%
|
0%
0
0
0
0
0
3
3%
|
2% ***
0
0
0
2
1
1
6%
|
| Success Rate (%) |
3 month |
6 month |
12 month |
|
Transvaginal (TV)
Laparoscopic (LP)
|
78% (N =18)
80% (N =75)
|
100% (N = 10)
80% (N = 61)
|
88% (N = 8)
64% (N = 14) ***
|
*** No patients who have reached their 3 month follow-up interval have
changed
their
continence
status
in
subsequent
follow-up
periods. The lower 12-month success rate is due to initial
physician
learning
curve
and
technique
refinement. The two LP intraoperative perforations were
due
to
difficult
access
and
unrelated
to
the
RF
instrument.
Conclusions:
RF bladder neck
suspension
appears
to
have
acceptable
short
and
intermediate
term
success
rates
and
a
low
complication
rate.
However,
further
study
is
required
with
more
patients
and
longer
follow-up
time.
1 Report on the surgical management of female stress
urinary
incontinence,
1997,
American
Urological
Association.
This
study
sponsored
by
SURx,
Inc.
