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British Journal of Urology (1976), 48, 675-680 0
A Simple Artificial Implantable Sphincter MICHAEL ROSEN
Department of Urology, Wollongong Hospiial, N.S. W., Awtralia
A new device to aid in the control of urinary incontinence is described. The idea of urethral compression to attain continence is not new (Berry, 1961 ; Kaufman, 1973; Scott, Bradley and Timm, 1974), but this device is physiologically superior because the urethra can be occluded and opened at will, in a simple fashion.
The Artificial Sphincter
The device is composed of a 3-pronged clamp, 2 arms of which are parallel on 1 side and a single arm carrying a balloon opposing them. These arms fit transversely across the urethra. The balloon is connected via reinforced tubing to a reservoir bulb containing isotonic saline and a release valve. The tubing is in 2 parts joined by a small connector piece to enable the device to be filled with isotonic saline. Compression of the bulb inflates the balloon elevating and compressing the urethra thus obtaining urethral compression and continence (Fig. I ) . Voiding is performed on deflating the balloon by pressing the release valve. The reservoir bulb and valve is sited in the scrotum and is easily palpable and manipulated (Fig. 2). The whole device is constructed of medical grade silicone elastomer (Fig. 3).
The Patients
16 patients are presented. The period of incontinence varied from 8 months following an abdomino-perineal resection, to 19 years following trauma and consequent paraplegia. There were 6 cases of incontinence following a T.U.R. and 3 cases following an open prostatectomy, and in 1 case the patient had had 3 T.U.R.s followed by subsequent open prostatectomy. 3 cases followed abdomino-perineal resection, and 2 cases were neurogenic bladders (see Table).
All patients had a routine medical assessment and all had an I.V.P., cystoscopy and a mictu- rating cystogram; some of the patients, in particular those with neurogenic disorders, had a cystometrogram. The operations were carried out under epidural anaesthesia in the majority of cases. Most patients received large doses of intravenous antibiotics commencing some hours before surgery and this was maintained for 48 hours and then oral antibiotics were continued for at least a week.
Method
The patients were prepared with shaving and cleansing of the skin of the lower abdomen, genitalia, perineum and buttocks on the evening before the operation. The bowel was sterilised with sulphathalazole for 3 days before the operation and neomycin the day before operation.
At operation the patient is placed in a slightly exaggerated lithotomy position and a 20 French
Read at the 32nd Annual Meeting of the British Association of Urological Surgeons in London, June 1976. 675
676
//Contra side members
BRITISH JOURNAL OF UROLOGY
Fig. I . The device.
Fig. 2. The device i r r sirrr.
SIMPLE ARTIFICIAL IMPLANTABLE SPHINCTER 677
Fig. 3. Largc and small device inflated.
sound is inserted in the urethra. An assistant’s hand is used to steady the sound and push it forward into the perineum. The anus is covered by a “Steri-drape”.
A midline perineal incision is made extending from the base of the scrotum to a point a little in front of the anus. The subcutaneous tissue is sharply incised in the midline until the perineal fascia and the urethral bulb is exposed. The urethra is then mobilised anteriorly and laterally from the fascia and deeply from the urogenital diaphragm. Superficial branches of the pudendal nerves and arteries on either side of the midline are not damaged by keeping in the midline. The urethra is separated from the urogenital diaphragm for a length of 2.5 cm. A ring retractor facilitates exposure. The sterilised prosthesis is filled to the maximum with isotonic saline. The 3-pronged clamp is then placed transversely across the urethra, the single arm deep and the parallel arms superficial. The sound is then removed. The parallel arms are then bent manually or with haernostats until they hold the urethra snugly. These arms are quite malleable and this manoeuvre is easily performed. The ends of the 3 arms are loosely approximated with a non-absorbable monofilament suture and then anchored to the urogenital diaphragm and deep surface of the perineal fascia. The arms on the other side of the urethra are similarly fixed. The tubing of the 3-pronged clamp is brought out by a stab wound through the perineal fascia laterally. At this stage the device is assembled and the tubing tied to the connector piece with non-absorbable sutures as a safeguard. The perineal fascia is sutured in the midline with a running continuous suture of 00 atraumatic catgut. Dissection is commenced to place the bulb in the scrotum and this is carried out in a superficial plane. The bulb having been placed in the scrotum the superficial perineal fascia is closed with a similar suture. The skin is closed with a running sub- cuticular suture of synthetic monofilament suture (Prolene) and the wound sprayed with protective adhesive.
No catheter is inserted and the device is left in the open position. The perineum receives dry
Tab
le
Nam
e A
ge
Cau
se o
f Pe
riod
of
inco
ntin
ence
in
cont
inen
ce
A. S
. R
. N.
R. J
. H
.
R. P
.
C.
H.
F. B
.
A. Y
.
F. H
. H
. C.
R.
H.
J. G
.
N.
W.
W.
N.
R.
C.
J. M
. H
. H.
71
83
55
63
74
66
47
71
67
60
65
71
71
34
65
74
T.U
.R.
Ope
n pr
osta
tect
omy
T.U
.R.
T.U
.R.
A b
dom
ino-
peri
neal
O
pen
pros
tate
ctom
y
Neu
roge
nic
U.M
.N.
Ope
n pr
osta
tect
omy
T.U
.R.
Abd
omin
o-pe
rine
al
T.U
.R. (
3) O
pen
T.U
.R.
T.U
.R.
Cau
da e
quin
a
A bd
omin
o-pe
rine
al
Ure
thro
tom
y
pros
t.
I ye
ar
5 ye
ars
1 + ye
ars
I ye
ar
2 ye
ars
2 ye
ars
19 y
ean
6 ye
ars
I+ ye
ars
1 ye
ar
3 ye
ars
2 ye
ars
5+ y
ears
7
year
s
8 m
onth
s 6
year
s
Dat
e of
op
erat
ion
Res
ult
FO
IIO
W-U
P
6 Ju
ne.
1974
25
Jul
y, 1
974
28 A
ug,
1974
2 Se
pt,
1974
6 Se
pt, 1
974
29 O
ct,
1974
27 M
arch
, 19
75
3 Ju
ly,
1975
4
Sept
, 19
75
9 Se
pt, 1
975
13 N
ov,
1975
4 D
ec.
1975
27 N
ov,
1975
5
F-b.
197
6
26 M
arch
, 19
76
9 A
pril,
197
6
Cur
ed
Cur
ed
Faile
d
Cur
ed
Cur
ed
Impr
oved
Cur
ed
Cur
ed
Faile
d
Faile
d
Faile
d
Faile
d
Cur
ed
Cur
ed
Cur
ed
Cur
ed
-
-
-
Dev
ice
faile
d
-
-
Infe
ctio
n
-
-
-
-
~ -
Dev
ice
faile
d
-
-
~ ~
~~~
Act
ion
-
-
Rem
oval
of
devi
ce
Inse
rt n
ew
devi
ce
Rea
djus
t de
vice
D
evic
e re
mov
ed
- -
Dev
ice
Dev
ice
Dev
ice
Seco
nd
rem
oved
rem
oved
rem
oved
devi
ce
-
Seco
nd
devi
ce
- -
Fina
l re
sult
~~ Com
men
t
Cur
ed
Cur
ed
Faile
d
Cur
ed
Cur
ed
Cur
ed
Faile
d
Cur
ed
Faile
d
Faile
d
Faile
d
Impr
oved
Cur
ed
Cur
ed
Cur
ed
Cur
ed
- - Se
psis
-
-
-
Seps
is
-
Seps
is fi
stul
a
Seps
is
Seps
is fi
stul
a
L
-
0
-
C
?
P r
3
7
A SIMPLE ARTIFICIAL IMPLANTABLE SPHINCTER 679
heat for 20 minutes twice daily and the running subcuticular suture is removed on the 7th day. The patient is not encouraged to manipulate the bulb even in the absence of scrotal oedema until the 7th day when the sutures are removed. The patient usually manages to manipulate the bulb very rapidly and can go home on the 9th or 10th day.
Results (Table)
Of the 16 patients operated on for a variety of reasons for incontinence, 10 have been cured, 1 improved and 5 failed. “Cure” was defined as not leaking any urine at all and not requiring pads or collecting devices, “improved” was defined as a patient who previously required a collec- ting device and now could wear pads or if he was already wearing pads, the number of pads used in a day was significantly reduced, and “failure” was defined as no improvement. No patient was made worse by the procedure.
Discussion
Several points for discussion emerge from the results. The incidence of fistula formation is low. It might have been thought that with direct compression of the urethra there would have been subsequent urethral wall necrosis and fistula development. In fact, only 2 cases of fistula occurred and 1 of these was iatrogenic. This patient (J . G.), on the evening of having the device inserted, developed gross scrotal oedema, extravasation of urine and retention and it was obvious that he had sustained urethral damage during the procedure of insertion. He had had 3 T.U.R.s, 1 open prostatectomy and a Kaufman prosthesis which had subsequently to be removed because of sepsis. A suprapubic cystotomy was done and he managed to retain the device for 3 months. The fistula in fact closed but there was so much woody oedema around the device that it could not be manipulated. It was painful to the patient and was therefore removed.
The other case of fistula (H. C.) developed some weeks following the insertion of the device. At no time was he able to manipulate the device and this fistula was certainly caused by and associated with infection. The device in this case was removed.
The other failures were due to sepsis. This was not the florid type of sepsis and in fact did not show much oedema, but there was tenderness at all times at manipulating the device and when finally the device was removed it could be seen that around the reservoir bulb there was a thick walled capsule with a 1 ml or less of pus present.
The “improved” case (N. W.) was due to a 2nd operation. At the 1st operation the device to be inserted was perforated and an older device had to be used. The operation went well and the patient recovered promptly but the device did not produce any significant reduction in his incontinence. 2 months later a 2nd device was put in. This was extremely easy to do and it was obvious at this time that the device becomes surrounded in non-infective cases by a thin serous lining. There was no difficulty in putting the urethral portion across the urethra and there was no suggestion of impending urethral wall necrosis. However, the device managed only to improve this patient, converting him from using a collecting device to pads.
The 2 cases of device failure were easily rectified. In I case the patient forgot to deflate the balloon to void and voided past the balloon; he felt and heard a popping sound in his perineum and became incontinent immediately. At reoperation a new device was inserted and this was successful. In the 2nd case of device failure, the connector piece had eroded through the reinforced tubing. In this case the 2 ends were freshened and a new connector piece inserted and this restored continence.
It can be seen from these results that most of the complications are due to infection and one cannot be too scrupulous about the preparation of the patient and the use of large doses of broad spectrum antibiotics intravenously at least initially. Epidural anaesthesia makes the operation very much easier, and age is no bar to surgery. The only contra-indications to this procedure
680 BRITISH JOURNAL OF UROLOCY
would be in those patients afflicted with a gross intention tremor, Parkinson's disease or senility.
Summary
A device is presented for the cure of urinary incontinence in males.
failures were due to sepsis. 16 cases have been operated on, 10 have been cured, 1 improved and 5 failed. Most of the
Despite this small number of cases the results are extremely encouraging. The device, because of its simplicity, both in construction and ease of insertion, is considered
worthy of extensive trials.
Addendum
Since this paper was delivered, 4 more cases of post-prostatectomy incontinence have been operated on and all have been cured.
References
BERRY, J . L. (1961). A new procedure for correction of urinary incontinence: preliminary report. Joiirt1ul (J/
KAUFMAN, J . J . ( I 973). Treatment of post-prostatectoniy urinary incontinence using a silicone gel prosthesis.
SCOTT, F. B., BRADLEY, W. B. and TIMM, G . W. (1974). Treatment of urinary incontinence by an implantahlc
Urology, 85, 77 1-775.
Brilish Joiirriul of Urology. 45, 646-653.
prosthetic urinary sphincter. Journal of Urology, 112, 75-80.
The Author
Michael Rosen, FRCS, Honorary Urologist.
