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Chapter 15 Innovative and Minimally Invasive Treatment
ports have confirmed a high curing rate with low morbidity.According to the producer Gynecare, more than 500,000 TVT operations have been carried out so far.
Kuuva et al. evaluated the therapy-associated morbidity of all patients who had
undergone a TVT operation in Finland by the end of the year 1999. The incidence of
bladder perforation was 3.8%, that of major vessel and nerve injury 0.1% and that of
urethral lesion 0.1%. The incidence of minor voiding difficulty was 7.6%, that of urinary tract infection 4.1%, of retropubic hematoma 1.9% and of vaginal defect healing
0.7% (Kuuva and Nilsson 2002).The rate of complications is comparable to the one described by Nilsson (Nilsson et al.2001).
Problems with bladder voiding occurred when the contractibility of the detrusor
was impaired,the bladder outlet obstructed or in the case of a combination of the two.
During recent years, many analyses of results and complications after TVT have
been published. In general, intra- and postoperative complications were few and included bladder perforations ranging from 4.9% to 6%,voiding difficulties 4%–12%, de
novo urinary urgency 7.4%–12%, urinary infections 3.1%–10.9% and retropubic hematoma 0.4%–1.7% depending on the publication. Both the intraoperative complications as well as the postoperative problems are associated with the individual
surgeon’s experience (Nilsson et al. 2001; Kuuva and Nilsson 2002; Karram et al. 2003;
Bodelsson et al. 2002; Meschia et al.2001; Moss et al. 2002; Debodinance et al. 2002).
Other rare intraoperative complications include bowel perforation, major vascular
injury, obturator nerve injury, urethra penetration and erosion (Vassallo et al. 2003;
Fourie and Cohen 2003; Meschia et al. 2002; Shobeiri et al. 2003).
Two prospective randomized studies have been performed to date to compare the
efficacy and the complications of TVT with those of Burch colposuspension in the
treatment of primary female stress incontinence (Liapis et al. 2002; Ward and Hilton
2002).The results are summarized in Table 15.1 and Table 15.2.
217
Table 15.1. Results of studies comparing Burch colposuspension and TVT procedure in the treatment of primary female stress incontinence
Prospective, Number of Follow-up time Cure rate Burch- Cure rate
randomized patients colposuspension TVT
study
Liapis et al.; 71 patients 24 months 86% 84%
Athens/ Greece;
Eur Urol 2002
Ward et al.; 344 patients 6 months 57% 66%
UK/Ireland;
BMJ 2002
Table 15.2. Results of studies comparing Burch colposuspension and TVT in the management of
primary stress urinary incontinence
– Six months and 2 years after the TVT procedure the operation proves as effective as the
colposuspension for the primary treatment of stress incontinence
– Operative complications are more common with TVT, but length of hospitalization is
shorter and the return to normal activity is possible earlier than with colposuspension
–Postoperative complications are more common after colposuspension
15
218
Christl Reisenauer,Konstantinos Gardanis,Diethelm Wallwiener
15.3 Other Tension-free Suburethral Slings for Treatment of Stress
Urinary Incontinence
15.3.1 Materials of Suburethral Slings
A wide range of materials have been used in fashioning a suburethral sling for the
treatment of stress urinary incontinence. Biomechanical comparison between autologous,allogenic or xenogenic biomaterials and synthetic materials showed that biomaterials such as dermis have less mechanical strength to support the urethra properly
(Choe et al. 2001). Infections such as AIDS, HCV, prions, etc. can make allogenic and
xenogenic biomaterials – at least theoretically – dangerous for recipients (Bidmead
and Cardozo 2000).
A randomized trial of porcine dermal sling (Pelvicol implant, Bard) vs TVT in the
surgical treatment of stress incontinence was conducted by a team from the UK.After
a median follow-up time of 12 months, the patient-determined cure rate was 85% in
the TVT group and 89% in the Pelvicol implant group.The prevalence of postoperative
voiding dysfunction and de novo urge incontinence was 3.4% and 9%, respectively,after TVT and 1.4% and 6%, respectively,after the Pelvicol implant (Arunkalaivanan and
Barrington 2003).
In comparison with polypropylene, the material that has been most thoroughly
studied, experimental data on collagen-based materials remain scarce.
In a long-term experimental study carried out with rabbits, tensile strength was
studied, among other material properties, comparing the different materials such as
porcine dermal collagen (Pelvicol, Bard), collagen matrix derived from porcine small
intestinal mucosa (SIS,Cook) and Prolene (Johnson & Johnson). Over a 1-year observation period, Prolene proved to have the highest tensile strength. Surgisis was not recognizable after 3 months. During the first half year, Pelvicol was as strong as Prolene,
but from the 180th day on, its strength decreased gradually (Claerhout et al.2003).
The chemical and physical properties of each synthetic material determine how the
sling is incorporated into the surrounding tissue and its susceptibility to infection,
erosion or rejection.Multifilament fibers may provide a safe harbor for small bacteria
and may exclude macrophages and leucocytes. In comparison in the mesh of monofilament fibers,tissue ingrowth and neovascularization is relatively enhanced and cellular access is not inhibited.Thus the risk of infection and erosion is higher when multifilament material is used.The nonwoven polypropylene has a lower grammage and a
lower elasticity than woven polypropylene (Fig. 15.2). No material has been as widely
accepted worldwide as the TVT (Niknejad et al. 2002; Iglesia et al. 1997; Staskin and
Plzak 2002).
Rechberger et al. showed that the clinical efficacy of both TVT (Gynecare) and IVS
(Tyco Healthcare) tapes was equally high, the only statistically significant difference
between the monofilament and multifilament tape being the higher rate of postoperative urinary retention in the monofilament group,probably caused by the greater elasticity of this tape compared to the multifilament one (Rechberger et al. 2003).
Tables 15.3 and 15.4 show most of the suburethral tapes that are widely used in surgery at present. Unfortunately, only very few of them have been evaluated as to their
complications and/ or success rate.Nevertheless we would like to mention the Remeex
Chapter 15 Innovative and Minimally Invasive Treatment
219
Fig. 15.2. Synthetic material used for the treatment of stress urinary incontinence
220
Christl Reisenauer,Konstantinos Gardanis,Diethelm Wallwiener
15
between two silicone pubic
columns
T-Sling Herniamesh, Approach: IVS Tyco, multi- Approach:
polypropylene joined transobturator supra- filament propylene vaginal
by absorbable suture pubic vaginal
Uretex Bard,poly- Approach: suprapubic Safyre Medic Approach:
propylene in a Teflon vaginal Service, pierced transobturator
Table 15.3. Suburethral slings for treatment of stress urinary incontinence
sheath polypropylene vaginal supra-
Serasis, Serapren, Approach: vaginal Stratasis® TF Cook, Approach:
submucosa
Serag Wiesner, biomaterial sling suprapubic
polypropylene small intestinal vaginal
L.I.F.T. Cousin Biotech, Approach: Remeex System Approach:
polypropylene sling transobturator Neomedic, suprapubic/
with a suburethral non- Suprapubic vaginal Readjustable poly- vaginal
woven patch propylene sling
between two Prolene
sutures
Emerald Gallini Medical Approach:
Devices, polypropylene transobturator
sling woven/nonwoven suprapubic
Chapter 15 Innovative and Minimally Invasive Treatment
Table 15.4. Suburethral slings for treatment of stress urinary incontinence
Suburethral sling Approach
221
readjustable sling (Neomedic International). The Remeex system is composed of a
suburethral sling with two traction thread sutures connected to a regulation device
(varitensor) positioned above the fascia of the abdominal muscles.The polypropylene
sling is placed at the urethrovesical angle. This surgical technique allows a postoperative adjustment of the sling tension,especially with patients who have undergone previous incontinence surgical interventions or have intrinsic sphincter deficiency, fixed
urethra or urethral hypermobility (Iglesias and Epuna 2003).
15.3.2 Approaches of Suburethral Slings
15.3.2.1 Antegrade Suprapubic Approach
The antegrade suprapubic approach is also used to place other midurethral slings,
such as SPARC (suprapubic arc sling systems,AMS), in order to avoid major complications of vascular or bowel injuries.SPARC differs from TVT in how the sling is placed
under the urethra. The SPARC needles are passed through two suprapubic incisions,
advanced under the pubic rami and enter at the level of the mid-urethra . In addition,
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Christl Reisenauer,Konstantinos Gardanis,Diethelm Wallwiener
Table 15.5. Approaches of suburethral slings
– Retropubic:
Vaginal (e.g., TVT)
Suprapubic (e.g.,SPARC)
– Prepubic: (TVT)
– Transobturator:
Outside-in (Uratape,Obtape, Monarc)
Inside-Out (TVT-O)
a knotted tensioning suture, which is unique to the SPARC sling, runs longitudinally
through the sling. This decreases the stretch on the mesh when plastic sheaths are removed (Tash and Staskin 2003).
The wide use of retropubic tension-free suburethral slings has been associated with
various peri- and postoperative complications. To reduce these complications,particularly with high-risk patients such as those who have been operated on before in the
lower pelvis, alternative approaches with a prepubic or transobturator passage of the
tape have been developed (Table 15.5). Continence rates obtained with these routes
have been similar to those obtained after the retropubic route.
15
15.3.2.2 Prepublic Approach
Prepubic TVT surgery (Fig. 15.3) can be carried out under local anesthesia and the
same instrument kit is used as in classic TVT.
As in classic TVT, the operation begins with a small incision under the mid-urethra.
Minimal paraurethral dissections are performed. Unlike classic TVT, the dissections,
which are needed to receive the preformed canals for the TVT needles, are directed
more laterally towards the middle of the ischiopubic bone.
The first needle is introduced straight into the preformed canal. When the ischiocavernosus muscle has been perforated,the needle is angulated straight upwards.Then
the needle is passed under the vulva to reach the small skin incision, which had been
made near the superior part of the pubic bone at the beginning of the operation. The
incision is situated in the middle between the genitofemoral fold and the midline of
the symphysis.
The second needle is then introduced at the other side of the urethra. When both
needles have reached the abdominal incisions, the ends of the tape are cut. The tape is
adjusted at a bladder volume at 300 ml.As the bladder cannot be perforated during the
procedure just described, cystoscopy is not necessary.When leakage has been proved
minimized during the cough test, the plastic sheaths are removed and the ends of the
tape are cut in the subcutaneous layer. Then the abdominal and vaginal incisions are
closed.
Chapter 15 Innovative and Minimally Invasive Treatment
223
Fig. 15.3. Pre-pubic tension-free vaginal tape
15
224
Christl Reisenauer,Konstantinos Gardanis,Diethelm Wallwiener
The short-term results with prepubic TVT seem to be similar to those with classic
TVT. After a mean postoperative follow-up time of 5 months,Daher et al. showed that
81% of patients were cured and another 13% improved; 6% of the operations failed.
Intraoperatively the vaginal wall was perforated when introducing the needle tip laterally to the pubic bone. This was discovered intraoperatively and the needles could be
reinserted properly without any postoperative healing problems. Postoperative residual urine of more than 100 ml was recognized in three patients. Some ecchymoses
were noted after the procedure (Daher et al. 2003).
15.3.2.3 Transobturator Approach
In the transobturator technique (Uratape, Obtape/Mentor,Porges) as described by Delorme (2001) the tape is inserted through the obturator foramina from outside the vulva to inside the vagina.
Although the transobturator sling’s out-in technique is claimed to be a safe procedure,it may cause urethra and bladder injuries.
De Laval (2003) described a novel surgical technique that allows the passage of the
tape through the obturator foramina, from inside to outside. This technique avoids
damage to the urethra and the bladder and makes cystoscopy unnecessary.
The Monarc transobturator sling(AMS) (Fig. 15.4) is passed from one obturator foramen to the other preserving an intact retropubic space (Pelosi and Pelosi 2003).
After making a small incision along the anterior vaginal wall 0.5 cm below the urethral meatus,the vaginal epithelium is separated from the underlying periurethral fascia using sharp and digital dissection. The internal edge of the obturator foramen is
identified. A skin incision is made bilaterally in the genitofemoral fold at the level of
the clitoris.
After the skin penetration, the needle passes the superficial perineal fascia and
crosses the adductor muscles of the thigh near their pubic bone origin and below the
insertion of the adductor longus tendon. Then the needle perforates the obturator
membrane, the obturator internus muscle and exits through the vaginal incision.The
way through the obturator foramen is in its upper-inner corner at a safe distance to the
obturator canal,which is located at the anterolateral upper margin of the obturator foramen. These steps are repeated on the contralateral side.
The polypropylene sling and its plastic sheath are connected to the needle tips at
the both sides. Then the needles are retracted through the skin incisions up to the
point where they are connected to the sling. After that scissors or tweezers are placed
between the urethra and the sling. The plastic sheaths from the slings are removed and
then the skin and the vaginal incisions are closed in the usual manner.
So far only short-term results are available, which state an efficacy similar to that of
the retropubic tension-free vaginal slings with less risk of overcorrection.
The transobturator vaginal tape inside-out procedure (TVT-O) as described by De
Laval (Fig. 15.5) allows the passage of the tape through the obturator foramina from inside to outside by using newly designed specific instruments (De Laval 2003).
The surgical procedure is generally carried out under spinal anesthesia but may also be performed under general or local anesthesia
Chapter 15 Innovative and Minimally Invasive Treatment
225
Fig. 15.4. Monarc (AMS) transobturator vaginal tape outside-in
226
Christl Reisenauer,Konstantinos Gardanis,Diethelm Wallwiener
15
Fig. 15.5. TVT-O (Gynecare) transobturator vaginal tape inside-out
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