Adjustable Continence Therapy for the treatment of male stress urinary incontinence: a single-centre study.

Abstract

To evaluate the Adjustable Continence Therapy (ProACT) device, a new device for the treatment of male stress urinary incontinence resulting from compromised sphincteric function.
A total of 64 males with post-prostatectomy incontinence underwent ProACT implantation. Efficacy was assessed by means of a daily pad count, a direct visual stress test, administration of the Incontinence Quality of Life (IQOL) and patient global impression (PGI) questionnaires and use of a visual analogue scale (VAS) to assess improvement in incontinence. These assessments were performed at baseline, 1, 3, 6 and 12 months after the procedure and annually thereafter.
The pad count declined from a median of 5.2 at baseline to 2 at 6 months and to 1.54 at 12 months. The median baseline IQOL score was 31.7, and this improved to 62.5 at 6 months and to 71.1 at 12 months. In terms of postoperative daily pad usage, 43 patients (67%) were considered to be dry, 10 (15%) improved and 11 (17%) unchanged. In terms of the post operative PGI score, 42 patients (66%) considered themselves to have improved greatly, 10 (16%) to have improved quite a lot, 6 (9%) to have improved slightly and 6 (9%) to be unchanged. The average improvement based on the VAS was 80%. The average number of postoperative adjustments was three (range zero to nine). Complications included infection (2/64; 3%), erosion of balloons (5/64; 7.6%), migration (2/64; 3%) and balloon deflation (2/64; 3%). Device removal was required in 9/64 patients (14%) but was easily achieved using local anaesthesia, and this thus permitted further therapeutic intervention. New balloons were implanted following endoscopic confirmation of urethral healing.
The ProACT device represents an efficacious treatment modality, which has an acceptable complication rate for a difficult group of patients.

Full text

Page 1

ORIGINAL ARTICLE
Adjustable Continence Therapy for the treatment of male stress
urinary incontinence: A single-centre study
ERVIN KOCJANCIC, SIMONE CRIVELLARO, STEFANIA RANZONI,
DANIELE BONVINI, PAOLO GONTERO & BRUNO FREA
Clinica Urologica, Ospedale Maggiore della Carita, Novara, Italy
Abstract
Objective. To evaluate the Adjustable Continence Therapy (ProACTTM) device, a new device for the treatment of male stress
urinary incontinence resulting from compromised sphincteric function. Material and methods. A total of 64 males with post-
prostatectomy incontinence underwent ProACT implantation. Efficacy was assessed by means of a daily pad count, a direct
visual stress test, administration of the Incontinence Quality of Life (IQOL) and patient global impression (PGI)
questionnaires and use of a visual analogue scale (VAS) to assess improvement in incontinence. These assessments were
performed at baseline, 1, 3, 6 and 12 months after the procedure and annually thereafter. Results. The pad count declined
from a median of 5.2 at baseline to 2 at 6 months and to 1.54 at 12 months. The median baseline IQOL score was 31.7, and
this improved to 62.5 at 6 months and to 71.1 at 12 months. In terms of postoperative daily pad usage, 43 patients (67%)
were considered to be dry, 10 (15%) improved and 11 (17%) unchanged. In terms of the postoperative PGI score, 43
patients (66%) considered themselves to have improved greatly, 10 (16%) to have improved quite a lot, 6 (9%) to have
improved slightly and 6 (9%) to be unchanged. The average improvement based on the VAS was 80%. The average number
of postoperative adjustments was three (range zero to nine). Complications included infection (2/64; 3%), erosion of
balloons (5/64; 7.6%), migration (2/64; 3%) and balloon deflation (2/64; 3%). Device removal was required in 9/64 patients
(14%) but was easily achieved using local anaesthesia, and this thus permitted further therapeutic intervention. Usually,
new balloons were implanted following endoscopic confirmation of urethral healing. Conclusion. The ProACT device
represents an efficacious treatment modality, which has an acceptable complication rate for a difficult group of patients.
Key Words: Stress urinary incontinence, adjustability, prostatectomy, balloons, quality of life
Introduction
There have been varying reports [1,2] concerning
the incidence and severity of post-prostatectomy
incontinence (PPI), depending on the surgical tech-
nique and individual definitions of incontinence [3].
About 6% of patients with PPI experience symptoms
severe enough to warrant further surgical interven-
tion [4]. The Artificial Urinary Sphincter (American
Medical Systems, Minnetonka, MN) is considered
the gold standard of surgical intervention [5]; how-
ever, its global adoption has been limited somewhat
by its cost, the invasiveness of the technique, and
therefore the skill required by the surgeon to perform
the procedure and manage the complications, as well
as the need for patient participation in the use of the
device [6,7].
Material and methods
The Adjustable Continence Therapy (ProACTTM)
device, developed by Uromedica Inc. (Plymouth,
MN) for the treatment of male stress urinary
incontinence (SUI), is a minimally invasive treat-
ment for this condition, which possesses the unique
feature that it can be postoperatively adjusted if
required. It consists of two silicone elastomer bal-
loons which are placed para-urethrally at the bladder
neck (in post-radical prostatectomy patients) or at
the level of the membranous urethra (in patients who
have residual prostatic tissue following benign sur-
gery). Each balloon is attached via a conduit to a
titanium port buried in the anterior lateral aspect of
the scrotum. Postoperative adjustment of the bal-
loons is facilitated by percutaneous injection of the
Correspondence: Ervin Kocjancic, Via Angoria 32, 33037 Pasian di Prato, Udine, Italy. Fax: ?39 43 255 2930. E-mail: e.koc@tiscali.it
Scandinavian Journal of Urology and Nephrology, 2007; 41: 324?328
(Received 14 August 2006; accepted 23 October 2006)
ISSN 0036-5599 print/ISSN 1651-2065 online # 2007 Taylor & Francis
DOI: 10.1080/00365590601153488

Page 2

port after a minimum of 4 weeks postoperatively,
with a 4-week interval being required between
further adjustments. The implant is available in 12-
and 14-cm lengths and each balloon can be inflated
to a volume of 8 cm3over time if necessary. The
ProACT device can be simply inserted using general,
spinal or local anaesthesia as required.
The procedure was performed using a similar
technique to that reported by Hubner and Schlarp
[8] and by Trigo Rocha et al. [9]. With the patient in
the lithotomy position, the bladder is emptied and
filled with 100 cm3of contrast solution. The filling
cystoscope is retained to maintain horizontal posi-
tioning of the urethra. Two small perineal stab
incisions are made on each side of the urethra to
allow passage of the balloons via designated blunt
and sharp trocars and an outer cannula. The trocar
is designed to perforate the pelvic floor and is gently
rotated so that it advances towards the bladder neck
or membranous urethra as appropriate. Image in-
tensification is used to identify the position of the
trocar in relation to the urethra and the desired final
position of the trocar. Once in position, the trocar is
removed and a tissue-expanding device is inserted
through the U-shaped channel of the cannula. This
device dilates only the area where the balloon will be
inflated. The choice of device length is generally
made based on the individual anatomical configura-
tion of the patient. Prior to insertion, the device is
primed to remove all air and is soaked briefly in
antibiotic solution. The trocar is removed and the
balloon inserted with the assistance of a push wire.
Once in position, the balloon is inflated using an
isotonic mixture of contrast medium and water using
a dedicated non-coring 23 G needle and syringe.
The process is repeated on the contralateral side. A
urethrogram should be performed to verify the
positions of the balloons and a 12 F Foley catheter
inserted overnight. A superficial pocket is created in
the sub-dartos fascia of the anterior lateral aspect of
the scrotum, taking care to ensure that the ports are
well separated and able to be easily accessed during
postoperative adjustments.
We set out to evaluate this procedure in a group of
males with urodynamic SUI who met the selection
criteria. Inclusion criteria included being able and
willing to provide informed consent and undergo
follow-up. Patients were excluded if they had poor
bladder compliance, an overactive or unstable blad-
der, a current bladder tumour or stones. Whilst PPI
was the major reason for patient presentation,
this was not a specific inclusion criterion, and men
with other aetiologies were also invited to join the
study. Following ethics committee approval (No.
2000D-9131), patients were enrolled and implanted
with the ProACT device. Patients were evaluated
using a daily pad count (0?1 safety pad/day?dry;
]2 pads/day but?50% pad reduction?improved;
and ]2 pads/day andB50% pad reduction?fail-
ure), administration of the Incontinence Quality of
Life (IQOL) [10] and patient global impression
(PGI) [11] questionnaires and use of a visual
analogue scale (VAS) [12] to assess improvement
in incontinence. These assessments were performed
at baseline, 1, 3, 6 and 12 months after the
procedure and annually thereafter. Additionally,
adverse events, number of adjustments, balloon
volumes and the overall patient impression based
on a global assessment score [ranging from 1 (greatly
improved) to 7 (very much worse) using the PGI
questionnaire] were determined at each of the post-
operative visits. Urodynamic evaluation of Valsalva
leak point pressures and measurement of mean
urethral closure pressure were performed at baseline
and a direct visual stress test was performed at
baseline and at each postoperative visit.
Results
Sixty-four male patients were implanted with the
ProACT device between July 2000 and September
2004, and all patients have now had ?12 months
follow-up. The mean follow-up period was 19.51
months (range 12?62 months). The mean age of
patients at the time of implantation was 65.4 years
(range 25?79 years). All patients had undergone
previous prostatic surgeries that resulted in SUI an
average of 4.4 years (range 1?12 years) previously.
Seven patients (10%) had undergone a number of
secondary procedures that may have further exacer-
bated their incontinence and six men (9.2%) had
undergone one or more previous procedures to treat
their urinary incontinence. The relevant previous
surgical histories of the patients are shown in Table I.
The mean operative time was 19 min (range
10?35 min). All patients underwent implantation
of the ProACT balloons using spinal anaesthesia.
Blood loss was B20 ml in each case. Analgesia was
not required postoperatively and patients were dis-
charged on average 1.1 days (range 1?2 days) after
implantation. Foley urethral catheters were usually
removed within 24 h postoperatively, but were
retained for 4 days (range 3?5 days) if operative
bladder perforation had occurred.
Table II shows the statistical improvement in
quality of life based on IQOL score at each time
point, and the trend in this improvement is shown in
Figure 1.
Table II shows statistically significant changes in
daily pad count over time. Figure 2 demonstrates the
reduction in pad usage at each postoperative visit.
Importantly, 68% of patients were pad-free (dry) at
ProACTTMstudy of male stress incontinence
325

Page 3

the last follow-up. Patient improvement based on
global assessment (PGI score) and VAS score are
described in Figures 3 and 4, respectively.
Adjustments were required in 61 patients (95%),
with a median number of adjustments of 3 (range
0?8). The mean final balloon volume was 3.1 ml
(range 1?8 ml).
Complications necessitating balloon removal oc-
curred in 11 patients (17%), and there were two
bilateral and nine unilateral removals. Balloon re-
moval was required as a result of erosion (n?5),
infection (n?2), migration (n?2) and balloon fail-
ure (n?2). Nine patients required balloon removal
within 6 months, and the remaining two patients
required it after ]6 months. Ten patients were
subsequently re-implanted at least 6 weeks later: two
became dry, six improved (one of whom required an
underwear liner) and two were unchanged. No
patients were worse following reimplantation. Op-
erative bladder perforation occurred in 5 patients
(7.6%) but was managed by way of a mean 4-day
(range 3?5 days) urethral catheterization period,
without further sequelae.
Eleven patients had previously undergone exter-
nal-beam radiotherapy prior to implantation of their
balloons: 4 (36.3%) were dry following adjustment,
2 (18.2%) were improved and 5 (45.5%) were
unchanged compared to baseline at the last follow-
up visit.
Three of these patients required removal of single
balloons due to erosion: 80% of these cases occurred
within 6 months following surgery, with the remain-
ing 20% occurring at 12 months. The volume of
the balloons at the time of erosion was equally
Table II. Changes in pad use and quality of life with time.
IQOL scorePad usage
Time (months)Mean SD
p
Mean SD
p
0
1
3
6
31.7
40.5
51.3
62.5
71.1
5.2
3.55
2.45
2.01
1.54
21.09
23.8
25.7
23.89
0.000063
B0.0001
B0.0001
3.29
3.15
2.83
3.01
0.000037
B0.0001
B0.0001
B0.0001 12
Table I. Initial causes of PPI and subsequent anti-incontinence surgery.
Original surgerySecondary procedurePrevious incontinence treatments
Bladder neck incision or internal urethrotomy,
n?7 (including three tertiary procedures) (10%)
Radiotherapy, n?11 (17%)
Bulking agents (including Macroplastique),
n?5 (8%)
Artificial urinary sphincter (removed
following erosion), n?1 (1.5%)
Radical retropubic prostatectomy,
n?57 (87%)
Radical perineal prostatectomy,
n?1 (1.5%)
Transurethral prostatectomy
(including HIFU), n?3 (4.6%)
Open prostatectomy, n?2 (3%)
Cystectomy and creation of
neobladder, n?1 (1.5%)
HIFU?high-intensity focused ultrasound.
0
10
20
30
40
50
60
70
80
0
(n=65)
1
(n=65)
3
(n=65)
6
(n=65)
Follow-up (months)
12
(n=65)
24
(n=22)
36
(n=08)
48
(n=07)
62
(n=07)
IQOL
Figure 1. Changes in IQOL score with time.
0
1
2
3
4
5
6
0
(n=65)
1
(n=65)
3
(n=65)
6
(n=65)
Follow-up (months)
12
(n=65)
24
(n=22)
36
(n=8)
48
(n=7)
62
(n=7)
Pads per day
Figure 2. Changes in daily pad count with time.
326
E. Kocjancic et al.

Page 4

distributed in the range 1.5?7 ml and was not
statistically significant based on a 95% CI.
Three patients had pre-existing sensory urgency.
Postoperatively, four de novo cases were reported,
but all seven of these patients experienced resolution
of symptoms following short-term anticholinergic
therapy within 1 month of surgery.
Discussion
The outcomes of this study raise some interesting
points. Firstly, the preliminary results appear to
demonstrate that implantation of the ProACT de-
vice may offer relief of symptoms in men with SUI
resulting from different causes.
In our experience, the implantation procedure was
easy both to perform and to reverse when necessary.
Interestingly, during implantation of the ProACT
balloons it was noted that those patients with
titanium haemoclips in the pelvic area presented
with more severe incontinence and had more scar
tissue, making placement of the balloons more
challenging.
Although we had implanted a number of patients
prior to commencement of the study, our placement
technique improved with experience, thereby redu-
cing the incidence of procedural-related complica-
tions. Additionally, analysis of the results highlighted
those patients more likely to experience complica-
tions, such as those who had undergone previous
radiotherapy. In terms of these irradiated patients,
although the success rate was less than that in the
overall group the dry/improved rate of 57% was
encouraging. The main complication in the irra-
diated patients was early erosion, which occurred
almost exclusively within this group. Reassuringly,
however, resolution was easy, with uncomplicated
removal of the device being possible in an outpatient
setting without further sequelae. Conservative bal-
loon inflation and adjustment regimens should be
adhered to in post-radiotherapy patients. The ability
to make postoperative adjustments was of great
benefit and, as shown by the numbers of adjustments
performed, was a well-utilized feature.
Other available therapeutic options, such as the
Artificial Urinary Sphincter [13], bulbar slings [14]
and injectable bulking agents [15], provide varying
rates of initial success using different approaches.
Whilst a few slings may be adjusted during a
secondary procedure [16], none have the ability to
be adjusted over time without surgical intervention
to maintain efficacy or offer the easy reversibility
of the ProACT device. For these reasons we think
that the ProACT device may become well accepted
from the patient’s perspective as a first-line treat-
ment option.
We will continue to offer the ProACT device as a
first-line surgical therapy for our patients, and to
further evaluate the long-term outcomes of our
already implanted males.
Acknowledgement
The authors thank Deborah Bell for her editorial
assistance.
References
[1] Majoras A, Bach D, Keszthelyi A, Hamvas A, Romics I.
Urinary incontinence and voiding dysfunction after radical
retropubic prostatectomy (prospective urodynamics study).
Neurourol Urodyn 2006;
[2] Walsh P, Partin A, Epstein J. Cancer control and quality of
life following anatomical radical retropubic prostatectomy:
results at 10 years. J Urol 1994;
[3] Pfister C, Cappele O, Dunet F, Bugel H, Grise P. Assess-
ment of the intrinsic urethral sphincter component function
in postprostatectomy urinary incontinence. Neurourol Ur-
odyn 2002;
[4] Fowler FJ Jr, Barry MJ, Lu-Yao G, Roman A, Wasson J,
Wennberg JE. Patient-reported complications and follow-up
treatment after radical prostatectomy. The National Medi-
care Experience: 1988?1990 (updated June 1993). Urology
1993;
[5] Klingler HC, Marberger M. Incontinence after radical
prostatectomy: surgical treatment options. Curr Opin Urol
2006;
[6] Hajivassilou CA. A review of the complications and results of
the implantation of the AMS artificial urinary sphincter. Eur
Urol 1999;
[7] Montague D, Angermeier, Paolone D. Long term continence
and patient satisfaction after artificial sphincter implantation
/25: /2?7.
/152:
/1831?6.
/21: /194?7.
/42:
/622?9.
/16:
/60?4.
/35: /36?44.
0
10
20
30
40
50
60
70
80
90
100
0
(n=65)
1
(n=65)
3
(n=65)
6
(n=65)
Follow-up (months)
12
(n=65)
24
(n=22)
36
(n=8)
48
(n=7)
62
(n=7)
% improvement
Figure 3. Changes in VAS score with time.
PGI score
9%
9%
0%
66%
16%
Extremely Improved
Very improved
Slightly improved
Unchanged
Slightly worse
Very worse
Extremely worse
Figure 4. Distribution of PGI scores at last follow-up.
ProACTTMstudy of male stress incontinence
327

Page 5

for urinary incontinence after prostatectomy. J Urol 2001;
166:
[8] Hubner WA, Schlarp OM. Treatment of incontinence after
prostatectomy using a new minimally invasive device:
adjustable continence therapy. BJU Int 2005;
[9] Trigo Rocha F, Mendes Gomes C, Lima Pompeo AC,
Marmo Lucon A, Arap S. Prospective study evaluating
efficacy andsafety ofadjustable
(ProACT), for post radical prostatectomy urinary inconti-
nence. Urology 2006;
[10] Wagner TH, Patrick DL, Bavendam T, Martin M, Buesch-
ing D. Quality of life of people with urinary incontinence;
development of a new measure. Urology 1996;
[11] Yalcin I, Bump RC. Validation of two global impression
questionnaires for incontinence. Am J Obstet Gynecol 2004;
189:
/
/547?9.
/96: /587?94.
continence therapy
/67:
/965?9.
/1:
/67?72.
/
/98?101.
[12] Frazer MI, Sutherst JR, Holland EFN. Visual analogue
scores and urinary incontinence. Br Med J (Clin Res Ed)
1987;
[13] Venn SN, Greenwell TJ, Mundy AR. The long term
outcome of artificial urinary sphincters. J Urol 2000;
702?7.
[14] Stern JA, Clemens JQ, Tiplitsky SI, Matschke HM, Jain P,
Schaeffer AJ. Long-term results of the bulbourethral sling
procedure. J Urol 2005;
[15] Kylmala T, Tainio H, Raitanen M, Tammela T. Treatment of
post operative male urinary incontinence using transurethral
macroplastique injections. J Endourol 2003;
[16] Sousa A, Mantovani F, Moretti M, Condelidis N, Neymeyer
J, Noguera R. Male Remeex System (MRS) for the treat-
ment of SUI: a multicentric trial. International Continence
Society Annual Meeting, Montre ´al, Canada, September
2005, Abstract 465.
/295:
/582.
/164:
/
/173:
/1654?6.
/17: /113?5.
328
E. Kocjancic et al.