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Chapter 17 Diagnostic and Surgical Management of Stress Urinary Incontinence
Fig. 17.3.
The Zuidex implacer is composed of
four prefilled syringes, each containing 0.7 ml Zuidex gel, syringes each
with a 21-G needle. A cannula covers
the needles for a smooth introduction
into the urethral lumen.Once withdrawn, the cover enables the surgeon
to prick into the urethral mucosa in
four sites under local anesthesia
stress incontinence after radical prostatectomy. Deflux injected in the area of the insufficient external sphincter appears to improve the continence for those patients after radical prostectomy (Alloussi 2004).
Calcium hydroxylapatite (Coaptite) has been developed to implant teeth in the
bone for jaw reconstruction. As a component of the bone, it seems to have no antigenic or inflammatory potential. In the 3-year follow-up study, Mayer et al. (2001) published ten patients’data that showed no complications and demonstrated an improvement or cure rate of 60%.
257
17.12 FDA-approved Bulking Agents
Another type of bulking agent is collagen. Collagen is widely used around the world
for many different applications. It is made from bovine dermis, mainly cross-linked
collagen types I and III. After injection,it becomes neovascularized and promotes the
invasion of fibroblasts. The advantages are that it is safe and easy to inject. Additionally, it has been proven that it does not migrate and ensures a minimal inflammatory response.Over time, it is replaced by host collagen (Remacle et al.1990).A disadvantage
is that a small group of patients might be allergic, and therefore a skin test is needed.
More importantly,long-term follow-up is still required, as the initial results show that
the cure rate is low and temporary.One side effect is that de novo urgency and/or persistent incontinence is seen in up to 13% of the patients and 2% of the patients face
temporary urinary retention. It appears that collagen’s early high success rate of
72%–100% decreases over time without re-injections. With respect to the so-called
long-term results, Herschorn and Radomski (1997) have published a cure rate of 72%
in the 1st year,which dropped to 57% after 2 years and 45% at 3 years.The continence
rate appears to be better with one or two additional treatments, with a mean of
5.6–15 ml collagen administered.
Durapher large particles or pyrolytic carbon-coated zirconium beads appear not to
migrate, although this has not been completely proven in the long term (Pannek et al.
2001). Because of the size of the particles, bigger injection needles are needed, with a
higher risk of retention in comparison to collagen. With a short follow-up of
12months, Lightner et al. (2001) looked into the data of 355 women with intrinsic
sphincter deficiency (ISD) and found equal effectiveness compared to the bovine collagen; however, less material was used.
258
Karl-Dietrich Sievert, Arnulf Stenzl
17.13 Tissue-engineered Stem Cells for Bulking: Dream or Reality?
Although there are a myriad of materials, none of those discussed in the sections
above seems to have the real potential to cure stress incontinence in the majority of
patients.Many are easy to inject and improve the patient’s quality of life for a specified
time. Several of these products are ideal for patients with co-morbidities who should
not or who do not want to undergo anesthesia.A disadvantage is that these substances currently need to be repeatedly injected.
Hopefully in the near future there will be more information with regard to autologous agents developed in the field of tissue engineering. Bent et al.published the data
of 32 patients after injecting tissue engineered cells. They demonstrated an increase in
the leak point pressure to over 90 cm H
proved in the follow-up after 1 year (Bent et al. 2001). With the application of primary
cultured skeletal myoblasts, Yokoyama et al. (2001) hoped that the amount of cells
would cause an obstruction in the bladder outlet but no long-term data exists as yet.
Strasser et al. (2004) published an improvement in female sphincter function both experimentally and clinically, albeit with short-term results to date. Follow-up data over
the next years will demonstrate if this technique will ensure success or if further improvements are needed.
Because it seems that the ideal substance,which is easy to inject without high pressure and decreases the chance of migration or rupture of the tissue, has not yet been
found, research will continue to search for an agent that can restitute the insufficient
external sphincter in its physiological function.
O.Half of the patients were cured and 31% im-
2
17
17.13.1 Mid-Urethral Synthetic Slings
17.13.1.1 Transvaginal Needle Procedures
The history of mid-urethral slings started with the Pareyra procedure in 1959. Over the
past years, different modifications to transvaginal needle application were made with
a different recognized outcome.However, it appeared that none of these modifications
lasted for the long term (Stamey 1973; Wennberg et al. 2003; Kuczyk et al. 1998). The
patient’s satisfaction was high compared to their presurgical status and in comparison
to the invasiveness of the procedure.However, long-lasting results are similar to those
of bulking agents. In comparison to other sling procedures,the sutures did not cause
tissue irritation or scarring compared with more invasive techniques.One major side
effect that is often seen is bladder perforation or the migration of nonresorbable sutures through the bladder wall, thereby causing chronic bladder infections or irritations known as de novo urgency.
17.13.1.2 Vaginal Slings
Because of the long-term outcome of the Stamey procedure, further techniques were
developed from the traditional pubovaginal sling first described by Giordano 1907
(Ridley 1985). These vaginal fascia of rectus muscle slings were placed primarily at the
level of the bladder neck through an abdominal approach. In a retrospective study,
Morgan et al. and Chaiking et al. found in the long-term follow-up that an allografted
Chapter 17 Diagnostic and Surgical Management of Stress Urinary Incontinence
Table 17.2. The success rate of the pubovaginal sling is similar, independent of the center performing this study and the percentage of“de novo”urge (5%–7%) and the persisting urge incontinence (23%–41% after more than 10 years of follow-up (Chaikin et al. 1998)
1 year 2 years 3 years 4 years 5 years 10 years
Morgen et al. (2000) No. patients 247 178 144 88
% cured SUI 93 91 88 85
Chaikin et al. (1998) No. patients 250 103 47 20
% cured SUI 94 94 95 95
fascia sling had a highly satisfactory outcome of 92% and with a cure rate of 85% after
5 years (Morgan et al. 2000) (Table 17.2). When autologous vs allografted slings were
compared at the time of a re-operation, Fitzgerald found that the cadaveric sling had
disappeared.This was interpreted as a cause of autolysis and a possible reason for failure in the long-term follow-up (Fitzgerald et al.1999). The cadaveric sling nevertheless
seems to be an alternative. Despite the fact that off-the-shelf material operation time
has been shortened, patients have to be informed that other procedures are available
with a longer follow-up.Brown and Govier (2000) compared autologous and cadaveric fascia data and saw a similar outcome.A minimum of 5 years follow-up is probably
needed to give the final recommendation. In order to have a true comparison of the
two materials, a random study with the same surgical technique needs to be conducted.
The modification with the bone-anchored sling has a similar outcome that does not
justify the more invasive technique; however, this procedure seems to be more preferred by individual surgeons.
259
17.14 Tension-Free Vaginal Tapes
The first approach of a mid-urethral sling with synthetics was undertaken with GoreTex with its well-known failures such as urethral perforations and fistulas. It seemed
for a long time that the use of foreign materials would not be used again to treat urinary stress incontinence. Almost a decade ago Petros and Ulmsten (1993) described
their integral theory and their use of what is now known as tension-free vaginal tape
(TVT). The introduction of new mid-urethral synthetic sling is currently restricted to
the following category of patients: obese,elderly, failed prior surgery,low average leakpoint pressure or mid-urethral closing pressure with hypermobility and concurrent
prolapse repair. An important criterion in placement is that the sling needs to be
loosely placed below the urethra. The name “tension free vaginal tape”probably best
describes the technique and what all these slings have in common. Other companies
have modified their technique with their specified synthetic sling material (Table 17.3).
The ideal synthetic material should be an inert material, have a large pore size to minimize the chance of colonization or infection and enhance the vascularization and tissue in-growth.
The overall outcome of slings depends upon the current group of previewed literature. The outcomes that have been published by the developers (Nilsson et al.2001) are
slightly better than the overall outcome of a nationwide analysis (Kuuva and Nilsson
260
Karl-Dietrich Sievert, Arnulf Stenzl
Table 17.3. Comparison of the different materials used as synthetic tapes
Type I Polypropylene (loosely woven)
Complete macro porous net
(porous >75 µm)
(Prolene,Gynemesh, TVT)
Type II Expanded polytetrafluoroethylene
Type III Macroporous nets
Type IV Submicro pores
Type I vs Type II and III:
Type I less foreign body reaction
Type I low infection rate
Type I better in-growths
(PTFE)
Complete microporous net
(porous <10 µm)
(Gore-Tex, Uratape)
with multi-filament
Or microporous components
(Parietex, Surgipro, Uretex)
(Not useable as a net)
17
2002).The long-term 5 year follow-up demonstrates similar overall outcomes to the so
called classic procedures (Fritel and Pigne 2002; Maaita et al. 2002; Sander et al.2002;
Olsson and Kroon 1999; Ulmsten 1998 and many others). The longer-term outcome
(more than 5 years follow-up) of the prospective sling studies demonstrates a cure rate
of about 84%–88% and a significant improvement of 7%–10% with only a failure rate
around 5%–8%.The outcome might depend on the mid-urethral closing pressure and
many others think the long-term outcome depends on the mobility of the mid-urethra. Fritel et al. pointed out in their study that where urethral mobility is above 60°,
the success rate is around 97%.When the mobility decreased to below 30°, the success
rate drops to 70%, where the mid-urethral closing pressure is not significant (Fritel et
al. 2002).
Chapter 17 Diagnostic and Surgical Management of Stress Urinary Incontinence
17.15 Comparison of Two Major Tapes
Additionally, several companies have developed their own system with a shorter follow-up.The SPARC system is one of them with a similar outcome. It has shown similar surgical complications in the 2-year follow-up, but it seems that the tape needs to
be surgically placed with a specific tension. In peer-reviewed literature, four studies
are available two of which an overall similar or identical outcome (Dietz et al. 2004;
Lim et al.2004). The major difference between Dietz et al. (2004) and Lim et al. (2004)
is that with the SPARC system, it was possible to bring in the needles from the abdomen, whereas the TVT system was able to make this approach only recently. The gynecologists seem to be more familiar with placing the needles through the vagina, while
urologists using the Stamey procedure seem to prefer the abdominal approach.In addition to the TVT and SPARC systems,other systems have been introduced in the clinic (Table 17.3). While the learning curve is short with most systems, surgeons should
usually look for the system they feels best with and stick with it so as to obtain the best
results over the long term.An important advantage to consider in selecting the system:
a reduction in operating times (approximately 30 min) and a system that can be done
under all types of anesthesia. Several departments perform this as an ambulatory procedure with a similar outcome compared to the golden standard techniques for SUI.
The successful indication has to be verified with a preoperative urodynamic evaluation. Urethral mobility can be predicted using the Q-tip test. This test is easy to perform and helps to choose the best technique (Bakas et al. 2002). The critical indications to avoid major complications appear to be a mobile urethra and the tape being
placed tension free (Table 17.4).
261
17.16 New Materials: The Resorbable Sling
Recently the modification of the tension-free vaginal tape as a subcutaneous prepubic
sling application has been presented. The long-term outcome needs to be demonstrated until it can be decided whether this procedure can be recommended (Daher et al.
2003). Over the past few years, new materials have entered the market. Such products
as xenograft acellular porcine dermis (Pelvicol by Bard,West Sussex, UK) and most recently, small intestinal submucosa (SIS, Stratasis by Cook, Ireland) (Table 17.5). With
the first short-term follow-up they might be an alternative to the synthetic slings
Table 17.4. Comparison of the nationwide analysis (Kuuva and Nilsson 2002) of complications
associated 1455 cases using the TVT procedure in Finland 2001 by Carl Gustaf Nilsson and those
of their own clinic (Nilsson et al. 2001)
Complications % (Kuuva and Nilsson 2002) % (Nilsson et al.2001)
Voiding difficulties 7.5 4.4
Urinary retention 2.3
Urinary tract infection 4.1 7.8
Infection 0.9 1.1
Hematoma 1.9 3.3
Bladder perforation 3.7 1.1
262
Karl-Dietrich Sievert, Arnulf Stenzl
Table 17.5. Acellular materials for urethra slings
Product Company Resorbable Source
Xenograft SIS Stratasis Cook Yes Porcine small intestine
Allograft Repliform Lifecell, Boston Yes Human dermis
Table 17.6. Comparison of different slings and their outcome
Authors Material used Patients Cure rate % Follow-up
Arunkalaivanan and TVT 142 76 6–24
Barrington (2003) Pelvicol 74
Berrington et al. Pelvicol 40 85 6–18
(2002) “sustained”
Ruter Porcine SIS with 152 93.4 4–48
Colvert et al. Stratasis 20 children 70 9–26
(2002) 85% Female
Pelvicol Bard No Porcine dermis
Alloderm Scientific
(months)
bone anchors
43% Male
(Arunkalaivanan and Barrington 2003; Rutner et al. 2003; Barrington et al. 2002; Colvert et al. 2002). Those xenograft materials might have a similar reliability as synthetic
slings; however, only a short follow-up of approximately 1 year is available (Table 17.6).
17
17.17 Transobturatoric Tension-Free Tapes
At the EAU 2003 in Madrid, Proget presented the transobturatoric tension-free tapes
with the Monarc System.The new approach avoids the retropubic space, theoretically
decreases the bladder perforation rate and voiding dysfunctions such as de novo urge.
The peer-reviewed data, with a short follow-up of up to 17 months, demonstrates two
ways to place the transobturator sling: inside-out and outside-in with an overall similar outcome, shorter operating time and intra- or postoperative complications (Delorme et al. 2003).
17.18 Retropubic Suspensions
The introduction for retropubic urethral suspension by Marshall (1949) and later the
modification of Burch (1961), changed the devastating condition of incontinent women in late 1940s.After the first meta-analysis of Jarvis et al. demonstrated for Burch vs
Marschall-Manchetti-Kranz (MMK) a cure rate of around 89.8% vs 89.5% (Jarvis
1994), several modifications have been described, but the most frequently quoted for
Chapter 17 Diagnostic and Surgical Management of Stress Urinary Incontinence
the Burch method has been Tanagho (1976) and for MMK, the Mayo Clinic (Symmonds 1972). Indications for this procedure are the urethral sphincter incompetence
and good vaginal capacity and mobility. The MMK method is only suitable for patients
with SUI and a cystocele grade I, whereas the Burch method is a good option for a coexistence grade I–III cystourethrocele (Stanton and Cardozo 1979). This method has
not been as historically successful. This is most likely because in the early days, only
one suture per side was placed.In laparoscopic surgery,several techniques have been
tried such as the Burch procedure (Moehrer et al. 2002). Today the laparoscopic approach is performed with the modification that at least two suture slings per side are
placed.
17.19 Artificial Urethral Sphincter
The artificial urethral sphincter is discussed in Chap. (Fig.17.4) (see Chap.18,”The Artificial Urinary Sphincter”).
17.20 What to Do When All the Efforts Did Not Result
in a Continent Patient?
Even if all recommendations in this chapter are followed and the surgery turns out as
planned, the long-term success of this approach cannot be predicted. Experts agree
263
Fig. 17.4. The artificial sphincter implanted in the female and male
264
Karl-Dietrich Sievert, Arnulf Stenzl
that the mobile urethra is the key indication for so-called tension-free vaginal tape.
Critical diagnostic tools such as the Q-tip test (Bakas et al. 2002), transvaginal ultrasound, and a lateral cystogram should be performed and if possible, while performing
the urodynamic evaluation.In those patients where a fixed urethra is found,a tensionfree tape will not cause the needed outflow resistance to make the patient dry.A tape
placed with tension might cause long-term erosion or even fistula of the urethra. It appears that the Burch colposuspension does have, in those cases,the best outcome.
No peer-reviewed literature was found in regard to predicting the best surgical
choice after the first prior one has failed.Obviously it is preferable to have the highest
long-term success rate for the first surgery.
17.21 After a Tension-Free Sling Did Not Bring the Desired Success
For a female patient, after a tension free vaginal tape has been introduced,persistent
urinary stress incontinence can be treated with additional bulking agent such as Zuidex (Fig. 17.3) to additionally increase the outflow resistant. Micro-balloons (Fig. 17.5)
might be as effective with a lower complication rate compared to the artificial sphincter (picture). The experience of ProACT is still limited and the first multicenter shortterm study appears to be very successful (Gilling et al.2004). This international study
group demonstrated in a study with a 2-year follow up that 50% of the patients were
cured and the remaining patients had only mild leakage.
17
17.22 The Sling with Tension
Initial follow-up publications with regard to an adjustable external mechanical regulator (ReMeEx) bladder neck sling are available.(Fig.17.6) This system, which is used in
cases with severe urinary stress incontinence, have a great benefit. The cure rate seems
to be between 83% and 96% in 38 patients with a follow-up of approximately 2 years
(Sousa-Escandon et al.2004; Mantovani et al. 2004).With a continued follow-up of additional patients,the outcome will be more accurate.It is also important to ensure that
the tension on this sling does not cause fistula or even an obstruction, even though
traction is required to close the bladder neck to improve or cure the incontinence.
With severe leakage, an artificial sphincter (Fig. 17.6) is often the surgical choice, although the implant has an almost certain chance of complications. If the urethra
and/or sphincter has been damaged by an unsuccessful implant or repair,a vesicostomy will be created with the appendix or an ileum segment using the Mitrofanoff technique. This nipple-pouch or an ileum-conduit might be a suitable alternative and provide the patient with a certain quality of life.
As we have discussed before, the patient needs all available information and the assurance that all questions have been answered in order to determine the pros and cons
of the each suggested surgical procedure.
17.23 Urinary Stress Incontinence in Men
The group of male incontinent patients seems to be small, perhaps for two reasons: it
is still a taboo subject for the male patient or it does not happen as frequently. Until
only recently, the artificial sphincter seems to be an option for the male patient. How-
Chapter 17 Diagnostic and Surgical Management of Stress Urinary Incontinence
Fig. 17.5a–c.
The micro-balloons (ProACT) and the instruments
for implantation (a).Im-
planted ProACT in female
(b), implanted ProACT in
male (c)
265
266
Karl-Dietrich Sievert, Arnulf Stenzl
17
Fig. 17.6a, b. The adjustable external mechanical regulator (ReMeEx) bladder neck sling from
Neomedic.a The system. b Placing the regulator
ever, with the above-mentioned systems there might be another option to treat male
urinary stress incontinence. There seems to be no peer-reviewed data available for
male urinary stress incontinence with the exception of micro-balloons and the readjust abele sling. During the last years hyaluronic acid, developed for reflux therapy, has
been used frequently in male patients after radical prostatectomy to treat urinary
stress incontinence. The outcome of this procedure still needs to be substantiated,as
well as how many times the patient needs further injections to maintain the result.
The surgical approach,which might be the best, should be evaluated very carefully.
It might be difficult to place micro-balloons effectively after radiotherapy or because
of scarring. With regards to the other techniques mentioned,no exclusion criteria have
been published.
17.24 Conclusion
The procedure to choose depends on the findings of the urodynamic evaluation. The
best surgical treatment, even with the best urodynamic tools, is hard to choose. The
continence mechanism is very complex and not totally understood. Each day,with new
information and greater understanding of physiological filling and voiding, the dia-
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