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INTRODUCTION
Although
urinary stress incontinence is a widely
recognized disorder and many different treatment
approaches have been developed, the anatomic
and physiologic factors that cause it are
not well understood. Excessive urethral
mobility appears to be the most pre-valent
factor that may cause urinary leakage when
there is an increased abdominal pres-sure1.
Most of the initial surgical treatment has
been developed to correct the urethral hyper-mobility.
With the popularization of sling pro-cedures,
it has been recognized that treatment needs
to be directed toward providing a sub-urethral
support mechanism, as well as curing
dure
for treatment of female urinary stress incontinence.4
Several recent reports docu-ment the initial
experience with this tech-nique5,6,7. The
results are very encouraging with cure rates
of >80% being reported in all these studies,
with minimal morbidity and a quick post-operative
recovery. However, the objective results
of most of these studies were based on a
cough-stress test and pad testing, rather
than the gold standard of a urodynamic evaluation.
In
this study, the morbidity and initial results
of the TVT technique for treating isolated
type II stress urinary incontinence at a
minimum follow up of 6 months were prospectively
evaluated. The patients were analyzed (both
before and after surgery) subjectively and
with a full urodynamic evaluation. Unlike
other stu-dies, this study includes women
who have pre-viously undergone unsuccessful
stress incon-tinence surgery.
PATIENTS AND METHODS
Twenty
patients with genuine stress incontinence
were included in this study. All patients
had more than a one-year history of stress
incontinence symptoms and they had also
requested a surgical solution to the problem.
Their mean age was 46.4 ranging from 32-68
years. Nineteen patients were multiparous,
and one patient was nulliparous. Five patients
(25%) had undergone a previous hysterectomy.
Of
the 20 studied patients, 6 (30%), had undergone
previous anti-incontinence surgery consisting
of anterior colporrhaphy in 3, needle bladder
neck suspension in 2 and retropubic colposuspension
in 1. In all these cases treat-ment had
failed and stress incontinence had recurred
or persisted.
A
special protocol was devised for the pre
and postoperative evaluation according to
the following criteria:
1. A thorough history of the duration and
severity of stress incontinence was taken.
2.
Physical examination and a stress provocation
test were performed in the supine and standing
positions with a comfortably filled bladder
(200-250 ml bladder volume recorded by ultrasound).
midline approximately 1cm cephalad and lateral
to the symphysis pubis. The vaginal epithelium
on either side of the urethra was grasped,
and a 1.5 cm midline incision in the anterior
vaginal mucosa was made at the level of
the mid-urethra. Using Metzenbaum scis-sors,
sharp and blunt dissection was per-formed
to mobilize the vaginal epithelium lateral
to the urethra for a distance of 1 cm. A
rigid catheter guide was placed into the
20 Fr. Foley catheter to move the bladder
neck away from where the TVT trocar and
introducer would pass into the retropubic
space. Move-ment of the catheter guide in
one direction will displace the bladder
to the contralateral direction. Therefore,
the catheter guide was directed toward the
patient's draped leg ipsilateral to the
side in which the surgeon intended to pass
the trocar.
The
TVT sling was constructed of undyed polypropolene
mesh measuring approximately 40 ×
1.1 cm. The mesh tape was covered by a plastic
sheath that allowed free passage through
the tissue and was separated at its midpoint
so that it could be removed once the sling
was in place. The TVT sling was secured
to a curved trocar, which was fastened to
an introducer.
The
TVT trocar was placed into the vaginal incision
lateral to the urethra and passed through
the endopelvic fascia into the retro-pubic
space. With care the trocar was directed
along the back of the pubic bone, through
the rectus fascia, and through the stab
incision in the abdominal skin. The same
procedure was repeated on the contralateral
side. With the two introducers in place,
the Foley catheter was removed and a cystoscope
was inserted into the bladder to ensure
that inadvertent penetration into the bladder
had not occurred. Once bladder penetration
had been ruled out, the rest of the trocar
was passed through the abdominal incisions,
thus bringing two ends of the TVT sling
through. When entry into the bladder was
confirmed by cystoscopy, the device was
removed and another attempt at trocar passage
was made in a more lateral direction. Once
both limbs of the TVT sling had been brought
through the abdominal incisions, haemostats
were used to secure the sling. The curved
trocars were released with a heavy blunt
curved scissors but care was taken not to
remove the plastic sheath encasing the sling.
A long blunt curved scissors was placed
between the vaginal portion of the sling
and the urethra
RESULTS
Mean
operative time was 22 minutes (range 18
to 36 minutes). No urinary leakage during
the intra-operative stress test under spinal
anaesthesia was noted. In 2 patients (10%)
the tension-free vaginal tape needle punctured
the bladder. The two episodes were recognized
intra-operatively on cystoscopy and the
needle was replaced uneventfully. In one
patient the urethral catheter was removed
on the third postoperative day with no subsequent
morbid-dity. The other patient required
catheterization for another 5 days. A history
of surgery for stress incontinence appeared
to be a signi-ficant risk factor with a
40% (2 of the 5 patients) rate of bladder
penetration in this subgroup versus no incidence
in patients without previous surgery.
There
was no case of excessive bleeding and none
of the patients required blood trans-fusion.
One patient developed a retropubic haematoma
and was treated conservatively.
Overall,
16 of the 18 patients without blad-der perforation
(89%) resumed immediate spontaneous voiding
after removal of the urethral catheter.
The postvoid residual urine was less than
100 cc in these patients. In two patients
repeated catheterization had to be performed
for 3 and 5 days. One of the two patients
who had bladder perforations resumed spontaneous
voiding on removal of her cathe-ter after
3 days, while the other required a Foley
catheter for another 5 days. No further
catheterization was then needed.
Urinary
tract infection developed during hospitalization
or immediately after discharge in 3 cases.
There was no vaginal or suprapubic infection
except in the patient who had deve-loped
a retropubic haematoma.
Patients
were discharged after a median of 1.5 days
postoperatively (range 1 to 4). Using the
described categories of surgical outcome,
16 patients (80%) were cured of stress incon-tinence,
3 (15%) were judged to have signi-ficant
improvement and in one (5%) the proce-dure
was considered to have failed. The three
patients with improvement reported occasional
leakage, mostly when sneezing with less
than two episodes weekly. The only case
of failure appeared after one month. There
were no further changes in the postoperative
outcome over time.
vided minimal morbidity, only 40% to 50%
of the patients were permanently cured13.
The Marshall– Marchetti – Krantz
(MMK) Procedure was introduced in 1949 and
involved elevating the bladder by securing
the periurethral tissue to the pubic bone
periosteum14. A cure rate of 84% has been
documented with this proce-dure15. Likewise,
the Burch procedure was developed in which
the periurethral tissues are secured to
Cooper's ligament16,17. Similar suc-cess
rates were documented when compared with
the MMK procedure18. Although these procedures
elevate the bladder neck and act to tighten
the underlying vaginal tissue, they do not
provide added suburethral support.
The
next advance in the technique was the development
of transvaginal procedures to re-suspend
the lower urinary tract. In 1959, Peyera
developed the first transvaginal bladder
neck suspension that secured the periurethral
tissue to the anterior rectus fascia18.
This operative technique formed the basis
for several later modifications developed
by Stamey19, Raz20, Gittes21 and others23,
24. The newer techniques vary in the extent
of dis-section of the periurethral tissues,
the use of graft material, the location
and number of sutures used in the supporting
periurethral tis-sues, and the use of different
needle carriers. Like the MMK and Burch
procedures, the transvaginal procedures
elevate the bladder neck but do not provide
additional suburethral support.
The
next technical advance was the popu-larization
of the sling procedure, which has the ability
to both reposition the bladder and provide
a stronger suburethral support mecha-nism.
Many different materials have been used
to construct the sling, including the anterior
vaginal wall, autologous muscle and fascia
(fascia lata, rectus fascia, gracilis muscle),
cadaveric fascia and synthetic substances,
such as nylon and polypropylene mesh. In
1997, the American Urological Association
and the Female Stress Urinary Incontinence
Clini-cal Guidelines Panel concluded that
the sling procedure and the retropubic suspensions
were the most effective surgical treatments
for female stress incontinence24.The panel
found that, when compared with the transvaginal
procedures, the sling procedures and the
retropubic suspensions had an increased
durability. The investigators demonstrated
that whereas the retropubic suspensions
and the sling procedures had cure rates
of 84% and 83%, respectively, the transvaginal
bladder
moval
of the catheter. The reason why so few intraoperative
and postoperative complications occurred,
despite the fact that the TVT might be considered
a sling–like procedure, is due to
the minimal tissue handling and the tape
being loosely placed around the mid-urethra
without elevation. In the mid-urethra, only
low tension is necessary for support. There
was no fiberoptic reaction, even in patients
with pre-vious surgery, since most procedures
were done more proximal at the bladder neck
level, and bladder neck funneling during
voiding was preserved. Short-term catheterization
was re-quired in only three patients. No
long-term catheterization or sequelae were
noted. On the other hand, in sling procedures,
8% of patients are likely to experience
urinary retention lasting more than weeks,
whereas 5% of patients undergoing a retropubic
suspension would ex-perience this degree
of obstructive uropathy28. New onset detrusor
instability that occurred only in the upright
position was observed in two cases (10%).
There was no obstruction on pressure flow
evaluation and an open bladder neck on voiding
cystourethrography. There-fore, it seems
that bladder overactivity may be related
to activation of the voiding reflex by stimulation
of the afferent receptors in the proximal
urethra. Moran et al. and Azam et al. reported
an incidence of de-novo detrusor instability
in 4% and 7% of their patients respectively7,29.
The rate of postoperative de-novo urinary
urgency in the retropubic suspensions and
sling procedures was reported to be 11%
and 7% respectively28.
An
analysis of urodynamic voiding variables
before and after surgery in the study shows
a significant decrease in the maximum flow
rate and a significant increase in voiding
detrusor pressure. However, these changes
were within normal values and there was
no significant change in the residual urine
volume. This suggests that there is an increase
in urethral resistance after the TVT procedure
and that it is not entirely tension-free
in practice.
The
intra-operative complications of the TVT
procedure were mainly associated with the
risk of bladder puncture. In our experience
bladder puncture occurred in two patients
(10%). These two punctures represent a 40%
puncture rate in patients with previous
anti-incontinence surgery (5 patients).
This rate is in keeping with other reports
which included patients with previous surgery10,29.
This study demonstrated that TVT surgery
should be done cautiously in recurrent stress
incon-
7.
Moran PA, Ward KL, Johnson D. Tension-free
vaginal tape for primary genuine stress
incontinence: a two-centre follow up study.
BJU Int 2000, 86:39.
8.
Haab F, Trockman BA, Zimmern PE. Results
of pubovaginal sling for the treatment of
intrinsic sphincteric deficiency determined
by questionnaire analysis. J Urol 1997,
158:1738.
9.
Bump RC, Mattiasson A, Bo K. The standardization
of terminology of female pelvic organ prolapse
and pelvic floor dysfunction. Am J Obstet
Gynecol 1996, 175:10.
10.
Haab F, Sananes S, Amarenco G. Results of
the tension-free vaginal tape procedure
for treatment of type II stress urinary
incontinence at a minimum follow up of 1
year. J Urol 2001, 169:159-162.
11.
Olsson I, Kroon UB. A three-year postoperative
evaluation of tension-free vaginal tape.
Gynecol Obstet Invest 1999, 48:267-269.
12.
Kelly HA, Dumm WM. Urinary incontinence
in women, without manifest injury to the
bladder. Surg Gynecol Obstet 1994, 18:444-450.
13.
Green TH. The problem of urinary stress
incontinence in the female. An appraisal
of its current status. Obstet Gynecol Surg
1968, 23:603-634.
14.
Marshall VF, Marchetti AA, Krantz KE. The
correction of stress incontinence by simple
vesico-urethral suspension. Surg Gynecol
Obstet 1949, 88:590-596.
15.
Marchetti AA, Marshall VR, Shultis LD. Simple
vesicourethral suspension. A survey. Am
J Obstet Gynecol 1957, 174-57-63.
16.
Burch JC. Urethrovaginal fixation to Cooper’s
ligament for correction of stress incontinence,
cystocele and prolapse. Am J Obstet Gynecol
1961, 81:281-289.
17.
Burch JC. Cooper’s ligament urethrovesical
sus-pension for stress incontinence. Am
J Obstet Gynecol 1963, 100:764-774,
18.
Peyera AJ. A simplified surgical procedure
for the correction of stress incontinence
in women. West J Surg Obstet Gynecol 1959,
65:223-226.
All correspondence to be sent to:
Ashraf
Abou Elela Elsayed, M.D.
Department of Urology
Cairo University
Cairo
Egypt
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the
urethral hypermobility. In 1994, DeLancey
proposed the "hammock hypothesis",
which states that "increases in urethral
closure pres-sure during a cough (stress
maneuver) arise because the urethra is compressed
against a hammock-like supporting layer,
rather than the urethra being truly intra
abdominal".2,3
The
tension-free vaginal tape (TVT) tech-nique
was introduced by Ulmsten et al.4 in 1996.
The procedure aims to recreate the urethral
support by the placement of a syn-thetic
sling (polypropylene mesh) at the level
of the mid-urethra via a minimal vaginal
incision. Ulmsten and colleagues reported
a 2-year cure rate of 84% with this minimally
invasive proce-
3.
A symptom and quality of life evaluation
was performed using a self-administered
questionnaire.
4.
A urodynamic evaluation with urethro-cystometry
and urethral profile measure-ment was performed.
Preoperatively, all patients had a urodynamic
diagnosis of genuine urinary stress incontinence
(GST) and a stable bladder. They all had
normal voiding function as defined by a
maximum flow rate of >15 ml/s for a voided
volume of >200 ml, a voiding detrusor
pressure < 40 cm water and a urinary
residual volume of < 100 ml.
5.
Postoperative evaluation also included examination
of the case notes with regard to operation
time, intra and postoperative complications,
bleeding, voiding prob-lems, signs of urinary
infection, defective healing and other complications.
Study exclusion criteria were urge incon-tinence,
detrusor instability, intrinsic sphincteric
deficiency defined by a valsalva leak point
pressure of less than 60 cm H2O with 200
cc in the bladder and a cystocele stage
II to IV ac-cording to the International
Continence Society classification system.
The
20 patients were asked to choose between
regional and local anaesthesia, so that
a provocative stress test could be done
during the procedure by asking the patient
to cough. Eighteen patients received spinal
anaesthesia (L2 to L3 level) according to
their preference. Two patients refused both
and received general anaesthesia. Broad-spectrum
parenteral antibiotic agents were administered
preoperatively and oral cephalosporin was
continued 48 hours postoperatively.
The
main aims of the tension-free vaginal tape
operation are to reinforce "functional"
pubourethral ligaments, thereby securing
a proper fixation of the mid-urethra to
the pubic bone and simultaneously reinforcing
to the suburethral vaginal hammock and in
connec-tion to the pubococcygeus muscles6.
For
the operation, the patient was placed in
the dorsal lithotomy position, and the abdomen
and vagina were prepared with povidone-iodine
solution. A 20 Fr. Foley catheter was placed
in the bladder. Two small stab incisions
(0.5 to 1 cm) were made on either side of
the
.in
order to provide a space between the sling
and the urethra. When tension was given
to the abdominal end of the sling care was
taken not to tangle the sling upon placement.
Ten-sion was applied to the two ends of
the sling until the sling fitted snuggly
around the blunt curved scissors. The scissors
was removed and a tension test was then
performed in which the urinary bladder was
filled with at least 250 ml sterile fluid.
The patient was then asked to cough and
continence was assessed. At this point,
the plastic sheath was removed from the
TVT sling and the abdominal ends of the
sling were cut, just below the surface of
the skin. The abdominal ends of the tape
were not sutured in place. The vaginal mucosa
was re-approximated in the midline with
absorbable sutures.
The
catheter was removed in the morning after
surgery unless bladder perforation had been
observed during surgery. When the post-operative
residual urine volume was more than 100
cc or the patient did not void, the catheter
was replaced for another 2-3 days.
Outpatient
follow up was performed at 1 and 3 months,
then 6 monthly. Follow-up evaluation included
questionnaire assessment of the symptoms
and patient satisfaction, pro-vocative physical
examination, cystometry, uroflowmetry and
recording of any short or long-term complications.
Treatment
outcome was assessed accord-ing to the following
criteria:
A
patient was considered completely cured
when she reported satisfaction with the
sur-gical outcome and no leakage on question-naire
analysis and when no urine loss occurred
on provocative physical examination and
cystometry with a full bladder.
A
patient was considered significantly im-proved
when she reported some leakage, but at least
more than 75% decrease in symptoms and an
overall satisfaction with the surgical outcome
based on the questionnaire evalua-tion and
when there was no urine loss on pro-vocative
stress test and cystometry with a comfortably
filled bladder (200-250 ml bladder volume
recorded by ultrasound).
Failure
was considered in all patients, even if
improved, who did not meet the above criteria.
There had been no preoperative uro-dynamic
evidence of detrusor instability. New onset
detrusor instability with uninhibited detru-sor
contractions during the filling phase of
cystometrography was diagnosed in two pa-tients
(20%). The contractions occurred only while
the patients were standing; no contrac-tions
were found when cystometrography was performed
in the supine position. There was no significant
bladder outlet obstruction on pres-sure
flow study and an open bladder neck on voiding
cystourethrography. Both patients com-plained
of new onset urgency symptoms with-out urge
incontinence episodes. They received anticholinergic
medication and showed signify-cant improvement.
Although
flow rates and voiding pressures showed
changes towards obstruction, none of the
patients had an abnormal flow pressure or
residual urine exceeding 100 cc after the
TVT procedure. Maximum urinary flow revealed
no or a slight decrease in 14 patients (70%)
and a decrease by more than 4 ml per second,
but still within normal, in 6 (30%). However,
only 3 patients (15%) reported one or more
symp-toms suggestive of voiding disorders
(hesitan-cy, prolonged stream, poor flow,
sensation of incomplete bladder emptying).
The mean maxi-mum flow was 18 ml per second,
ranging from 16 to 20 ml/sec. These cases
continued to be monitored for signs of increasing
post-void residual urine. Each patient had
less than 100 ml post-void residual urine.
In cured patients, the urethral closure
pressures positively increased after the
operation.
No
case of mesh infection or rejection was
noted at follow up and none of the patients
required removal of the tape.
DISCUSSION
Stress
urinary incontinence is a devastating condition
that affects 10% to 20% of females in the
general population1,10,11. In the previous
century, much study was undertaken to deter-mine
the aetiology and pathophysiology of stress
urinary incontinence in female patients
and many different treatment approaches
and modifications have been developed. Most
of the initial surgical treatment developed
has focused on re-suspending the bladder
neck to correct the urethral hypermobility.
The first pro-cedure was developed by Kelly
in 1911 and involved anterior colporraphy
with plication of the urethra12. Even though
this procedure pro-
neck suspensions were curative in only 67%
of patients. However, they also concluded
that the more efficacious procedures had
significant added morbidity.
Recently,
Delancey proposed the “ham-mock hypothesis”
to describe the patho-physiology of female
stress incontinence2. According to this
theory, in the normal con-tinent female,
the increase in urethral closure pressure
during cough (stress maneuver) arises because
the urethra is compressed against a hammock–like
stable supporting layer, rather than the
urethra being truly intra-abdominal, while
in incontinent females, the unstable supportive
layer is ineffective in providing resistant
back stop against which the urethra can
be compressed. According to Delancey, treatment
of female stress incon-tinence, therefore,
should focus on recon-structing this supporting
tissue, not on elevat-ing or repositioning
the urethra. The findings of Delancey were
consistent with the anatomical study of
Zaccharin, who advocated the role of anterior
pubourethral ligaments for maintaining continence25.
The
latest development in the treatment of female
stress incontinence is the minimally invasive
tension-free vaginal tape (TVT). This procedure
was first described and evaluated by Ulmsten
et al.4 in 1996. The TVT procedure involves
recreating urethral support with a polypropylene
mesh, without repositioning of the bladder
or securing the periurethral tissue to pelvic
structures.
Conventional
suprapubic sling procedures have the highest
success rate for controlling leakage in
published reviews, although there is generally
a higher morbidity than after other suprapubic
procedures26,27. Therefore, the po-tential
for combining a sling–type procedure
with low morbidity is extremely attractive
to surgeons and patients.
The
results of this study are in keeping with
other studies documenting the TVT proce-dure.5,6,7,10,26.
The subjective and objective cure rates
for genuine stress incontinence were high
(80% and 95% respectively), and consistent
with the rates expected from colposuspension27,28.
However, the apparent advantages in the
short term in this study were obvious; the
mean operative time in most cases was <30
min with patients usually discharged within
24 – 48 hours and 85% of the patients
spontaneously voided after re-
tinence
due to scarring and tethering of the bladder
in the fibrotic retropubic space. How-ever,
no long-term complications due to blad-der
puncture were noted, provided it was recognized
during the procedure. Thus, intra-operative
cystoscopy is mandatory during the TVT procedure.
Our
overall results in a selected group of women
without sphincteric deficiency or detru-sor
instability were 85% completely cured, with
another 5% considerably improved. These
results are similar to those previously
reported by Ulmsten et al.4,5
In
conclusion, the tension-free vaginal tape
procedure appears to be a minimally invasive,
safe and effective treatment for type II
stress urinary incontinence. A history of
surgery for stress incontinence did not
interfere with the results but appeared
to be a risk factor for bladder perforation
which was significantly higher in this subgroup.
A longer follow up is necessary to evaluate
precisely the risk of detrusor instability
due to bladder neck and proximal urethra
funneling. Unlike the colpo-suspension,
TVT causes no elevation of the bladder neck
and no reduction in bladder neck mobility.
This explains the low incidence of voiding
complications.
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