Original article by Menahem Neuman Urogynecology, Dept. of Gynecology: “Shaare Zedek”, Ben-Gurion University of the Negev, “Hadassah-Har-Hazofim” and “Assuta” Medical Centers, “Leumit Advanced Personal Healthcare” and “Meuhedet Health Fund”
Aim: To evaluate the technical
aspects and training process of the TVT-SECUR – a novel minimally
invasive anti-incontinence operative procedure. Methods. With this
prospective, observational and consecutive patient series, the
TVT-SECUR operation was taught by one trainer to experienced pelvic
floor surgeons on 100 patients with urodynamically proven stress
urinary incontinence. Peri-operative data was prospectively
collected. Results. The surgical aspects of these 100 patient’s
parameters were evaluated. No voiding difficulties, significant
pain, or any other patient inconvenience was observed
post-operatively. The early therapeutic failure rate for the
TVT-SECUR procedure was 9.0%. Four patients had vaginal wall
penetration with the inserters, requiring withdrawal and
re-insertion as well as vaginal wall repair. Three other patients
needed trimming of a vaginaly extruded tape segment, done in the
office with satisfactory results. Five patients had un-intended tape
removal at the time of inserter removal, necessitating the usage of
a second TVT-SECUR. No signs for bowel, bladder, or urethral
injuries, intra-operative bleeding or post-operative infections were
evident. Conclusions. Use of the TVT-SECUR, a novel mid-urethral
sling, seems to be a safe anti-incontinence procedure. Operative
complications associated with the TVT, such as bladder penetration
and post-operative outlet obstruction as well as the TVT-Obturator
complications such as post operative thigh pain and bladder outlet
obstruction seem to be reduced with the TVT-SECUR.
The Tension-free Vaginal Tape (TVT) procedure is a well-established
surgical procedure for the treatment of female stress urinary
The operation, described by Ulmsten in 1996, which is based on a
mid-urethral Prolene tape support, is accepted worldwide as an
easy-to-learn, effective and safe surgical technique. 1-5
Some typical TVT operative complications of concern to the
operating surgeons include: bladder penetration, urinary outlet
obstruction, potential bowel penetration, intra-operative bleeding
and post-operative infections. 2, 3, 5-9
Against this background, Jean de Leval was encouraged to design a
novel mid urethral sling in the form of an “inside-out”
trans-obturator TVT-like procedure. In such, the TVT needle bypasses
the retropubic area, which is in intimate proximity with the
bladder, bowel and blood vessels, by making the needle route pass
through the relatively safe medial compartment of the obturator
fossa area, remote from the pelvic viscera and vessels. 10
The TVT-Obturator was shown to be a safe and easily performed
minimally invasive anti-incontinence procedure. 11-12
The novel TVT-SECUR was designed to overcome two of the
peri-operative complications reported with use of TVT-Obturator:
thigh pain and bladder outlet obstruction. 11-12
This was addressed by tailoring the tape to be only 8 cm long and
anchoring the tape edges into the internal obturator muscle, rather
than passing it through the obturator foramen, muscles and membrane.
The initial pull-out force of the tape and further tissue ingrowth
were studied in the sheep model, revealing satisfactory figures.
The aim of the current analysis was to evaluate the operative data
collected with early training in the first 100 novel, minimally
invasive anti-incontinence procedures.
Patients suffering from urinary stress
incontinence with no intrinsic sphincteric deficiency, based on
subjective complaints and objective clinical signs and confirmed
with urodynamic diagnosis including cystometry, uroflowmetry and
stress test, were prospectively and consecutively referred for
corrective surgery from 25/9/2006 to 25/12/2006.
One hundred TVT -SECUR training procedures were performed after
receiving profound consultation and explanation of the informed
consent, highlighting the novelty of the procedure, the lack of
experience and the training issues. This operative series of Hammock
approach was done at 13 hospitals with one single trainer having
previous experience with 35 TVT-SECUR operations. All patients were
given one gram of Monocef (Cefonicid, Beecham Healthcare)
intravenously, one hour prior to surgery and were subjected to an
iodine antiseptic prophylactic vaginal wash prior to commencement of
The mode of anesthesia depended on patient request. No Foley
catheter was placed and no diagnostic cystoscopy was performed.
Pelvic floor relaxation was recorded in accordance with the ICS
pelvic organ prolapse quantification system (POPQ). 14
Patients presenting with significant pelvic organ prolapse had
colporrhaphies (anterior and posterior) with or without implantation
of vaginal mesh (ProLiftTM, Gynecare, Summerville, NJ) implantation
for pelvic floor concomitant with the anti-incontinence surgery.
Hysterectomies were not performed with this series. Operative
bleeding was managed with hemostatic suture placement via vaginal
Intra-operative and early post-operative complications within
this patient series were recorded. Patients were interviewed and
subjected to pelvic examination at the ends of the first and second
post-operative months. The clinical findings regarding urine and
feces leakage and prolapse were also collected according to the ICS
standards terminology. 14
Therapeutic failure was defined as persistent urinary stress
incontinence, that affected her quality of life, reported by patient
and clinically confirmed. Minimal residual leakage, not
deteriorating the patient’s quality of life, was mentioned but not
regarded as therapeutic failure.
Patient’s pre-operative, operative and
post-operative details have been tabulated in
Table 1 and
According to the POPQ system, 14 48 patients (48.0%) had
an advanced cystocele (Aa/Ba>+1), 19 (19.0%) had an advanced
rectocele (Ap/Bp>+1), 2 (2.0%) had uterine prolapse (C>+1) and 5
(5.0%) had vaginal vault prolapse (C>+1). All patients had the
TVT-SECUR as primary anti-incontinence operation.
Fifty one patients (51.0%) underwent concomitant operative
procedures in addition to the TVT-SECUR: 48 patients (48.0%) had
anterior and 19 (19.0%) had posterior colporrhaphies, Eleven
patients (11.0%) had anterior ProLift, 2 (2.0%) had posterior
ProLift and 5 (5.0%) had total ProLiftTM operation (Gynecare) for
the support of the vaginal walls and apex. No hysterectomies where
performed with this patient’s series.
The 82 trainees where experienced pelvic floor staff surgeons, 28
(34.1%) of them where Urologists and 54 (65.9%) Gynecologists, each
performed one or two operations. The mode of anesthesia was subject
to patient’s request, resulting in general in 52 (52.0%) operations,
regional in 11 operations and local in 37 (37%) operations. No
anesthetic mode appeared to be superior in terms of facilitating the
procedure or the recovery.
The TVT-SECUR patients were followed up
for period of 2 to 5 months. Therapeutic failure, meaning sustained
urinary stress incontinence, was diagnosed in 7 out of the first 35
patients (20.0%). Seven (20.0%) other patients reported residuals
non-significant post operative leakage, not influencing quality of
life and hence not regarded as therapeutic failures. Acknowledging
these figures, the mesh tension was subsequently minimally increased
with the last 65 patients and a further two failure patients (3%)
In total 9 patients (9%) failed. No clinical signs for operative
bleeding, bladder or intestinal penetration, post-operative
infection, bladder over activity or outlet obstruction were
observed. Four patients (4.0) had vaginal wall penetration with the
inserters, requiring withdrawal and re-insertion as well as vaginal
wall repair. This was avoided later by making the preliminary
sub-mucosal tunnel as wide as 12 mm to permit the device to slip in
smoothly. With such, no further vaginal penetrations were noted.
Three other patients (3.0%) presented with vaginal tape extrusion,
this was easily resected in office and no morbid sequela was
recorded. After incorporating suburethral dissection to the
procedural steps and allowing the tape to sink away from the vaginal
mucosa – no more mesh extrusion occurred.
Five patients had un-intended tape removal at the time of inserter
removal, necessitating the usage of a second TVT-SECUR. This was
addressed by proper inserter separation from the tape prior to its
withdrawal, and with such, no further unintended tape displacements
were recorded. One patient had to be taken back to theater for
evacuation of an early post operative para-vesical hematoma of 50
ml. Hematocrit level was not altered and neither blood transfusion
nor bleeding control measures were required. All the above mentioned
complications, other than the one case of hemorrhage and one case of
vaginal tape extrusion, occurred with the first 42 patients.
The TVT procedure has become very popular ever since it was first
described by Ulmsten in 1996. Common complications in previously
performed surgeries for the treatment of stress urinary
incontinence, such as intra-operative blood loss, pelvic and
abdominal organ injury, post-operative de novo detrusor instability,
dyspareunia and urethral erosion, are rare in the TVT era. 1-5
Prospective randomized multi-center studies, comparing TVT to the
former gold standard Burch colposuspension, demonstrated similar
therapeutic impact for both. However, TVT was associated with a
higher intra-operative complication rate while colposuspension was
associated with a higher post-operative complication rate and a
longer recovery period. 16-17
The previously reported TVT-related complications included
bladder penetration, intra-operative bleeding, post-operative
infection and vessel and bowel injuries. 1-3, 5-8
Since surgical procedures are more likely to cure stress urinary
incontinence rather than non-surgical procedures, 18 de
Leval adapted the TVT-Obturator procedure to avoid the
aforementioned complications. His novel type of surgery enables mid
urethral support for the treatment of female urinary stress
incontinence, while not encroaching on the bladder, the femoral
blood vessels, or the bowel.
This is achieved by exploiting the obturator fossa as a route for
the Prolene tape, replacing the retropubic space. The reported data
regarding efficacy of the TVT-Obturator in terms of cure as well as
intra-operative and early post-operative complication rates is
Bladder penetration, previously reported in relation to
“outside-in” trans-obturator designed mid urethral tape procedures,
19-20 has not been described in association with an
“inside-out” trans-obturator procedure. Though bladder perforation
could not be ruled out as diagnostic cystoscopy is not routinely
performed, the absence of any indicative signs provides additional
support to the idea that the TVT-Obturator does not cause bladder
Therapeutic failure, intra-operative bleeding, post-operative
infection and voiding difficulties also seem to occur less with the
TVT-Obturator than previously reported for TVT. 2, 3, 5, 8,
However, the TVT-Obturator is not free of operative
complications: thigh-pain is reported to interfere with patient
satisfaction, operative infections and post-operative bladder outlet
obstruction still occur as well as occasional operative hemorrhage.
The TVT-SECUR was designed to minimize
the operative procedure as much as possible in order to reduce those
undesired complications. 21 This new device is composed
of an 8 cm long laser cut polypropylene mesh and is introduced to
the internal obturator muscle (Hammock position) by a metallic
inserter, while no exit skin cuts are needed.
This approach imitates the sub-mid-urethral support provided with
the TVT-obturator, yet imitating the TVT is possible as well, by
introducing the TVT-SECUR arms retropubically rather than to the
obturator area. This “U” position approach necessitates urethral
catheterization as well as diagnostic cystoscopy for recognition of
possible bladder penetration. As the main possible advantage of the
TVT-SECUR is minimalisation of the procedure and its side-effects,
the simpler “ham mock” approach was elected for this patient’s
The 100 teaching operations reported herein served for training
TVT-SECUR to experienced pelvic floor surgeons. It was obvious that
the first trainee’s tended to use their previous knowledge and
experience gained with the former mid-urethral slings to the
performance of this newly developed surgical device. Given that the
new laser cut tape and novel inserters are different than the former
equipment, one could understand the trainer’s early learning curve
difficulties. Laser cutting of the Secur tape is thought to greatly
diminish the fraying previously seen with the mechanically cut tape.
The elasticity of the laser cut mesh is, however, the same as the
mechanically cut mesh within the physiologic range of forces applied
to a mid-urethral tape. However, it does not “rope out” and remains
flat under the urethra. The extra tension applied to the TVT and
TVT-Obturator tapes during removal of the covering plastic sleeves,
does not occur with the TVT-SECUR. Hence, some extra tension needs
to be applied to the TVT-SECUR compared to the TVT in order to
achieve the desired therapeutic result. Even doing so, no clinical
signs for post-operative bladder outlet obstruction were observed.
To accommodate the flatter, wider tape under the urethra that laser
cutting produced, further mucosal undermining was done in order to
permit the tape to sink deeper, away from the vaginal mucosa. The
inserters, being more than twice as wide as TVT and TVT-Obturator
needles, necessitate wider tunnels; 12 mm at least, in order to
permit smooth passage of the tape and inserter and avoid gathering
of vaginal skin which might lead to vaginal wall penetration.
The tunnel depth should not go beyond the bone edge to avoid
damaging the tissue meant to hold the coated tape edge; otherwise
the initial pull out force might be impaired. The unique locking
mechanism, attaching the tape to the inserter, should be unlocked
properly and detached gently, to avoid unwanted tape removal with
withdrawal of the inserter. Doing these simple surgical steps the
author was able to lead the trainees toward successful completion of
In summary, the TVT-SECUR
procedure appears to be potentially easier to perform and relatively
trouble-free for both surgeons and patients and might not require
urethral catheterization or diagnostic cystoscopy during surgery.
Paying respect to the above mentioned procedural specific surgical
steps might shorten the TVT-SECUR learning curve. The novel
TVT-SECUR’s actual place among TVT and TVT-related procedures can
only be determined with randomized prospective longitudinal
The data presented here supports the
notion that the TVT-SECUR, a novel mid-urethral sling operation for
the treatment of female stress urinary incontinence, seems to be
safe and easy to perform. Intra-operative diagnostic cystoscopy and
bladder catheterization might not be mandatory for an experienced
surgeon when using the Hammock approach.
The TVT-SECUR procedure might be associated with fewer
complications, both intra-operatively and post-operatively, than
previously reported for the TVT and TVT-related procedures. One
should respect the above mentioned special features of this novel
procedure to ensure simplicity, safety and security. Randomized
comparative controlled trials and long-term follow-ups are still
required to clarify the relative places of the different
mid-urethral tape anti-incontinence techniques.
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Disclosure: The author is a TVT SECUR trainer for Gynecare, Summerville, NJ.