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Conclusions: The surgical options for the treatment of stress urinary inconti- TMUS transobturator mid ure-
thral sling
nence continue to evolve; as such, this guideline and the associated algorithm
aim to outline the currently available treatment techniques as well as the data TVT tension-free vaginal tape
associated with each treatment. Indeed, the Panel recognizes that this guideline UUI urgency urinary
will require continued literature review and updating as further knowledge incontinence
regarding current and future options continues to grow.
Accepted for publication June 10, 2017.
The complete unabridged version of this
Key Words: female; algorithms; urinary incontinence, stress guideline is available at http://jurology.com/.
This document is being printed as submitted
independent of editorial or peer review by the
editors of The Journal of Urology.
0022-5347/17/1984-0875/0 http://dx.doi.org/10.1016/j.juro.2017.06.061
THE JOURNAL OF UROLOGY
2017 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH, INC.
Vol. 198, 875-883, October 2017
Printed in U.S.A.
www.jurology.com j 875
876 SURGICAL TREATMENT OF FEMALE STRESS URINARY INCONTINENCE
Table. AUA nomenclature linking statement type to level of certainty, magnitude of benefit or risk/burden and body of evidence
strength
Figure. Evaluation and treatment algorithm for female stress urinary incontinence
878 SURGICAL TREATMENT OF FEMALE STRESS URINARY INCONTINENCE
procedure or recurrent SUI at a later time that may data that exceed 15 years of follow-up.6,7 Success
require further intervention. rates are reported to be between 51 and 88%. The
10. Prior to selecting synthetic MUS proced- retropubic top-down versus bottom-up approach
ures for the surgical treatment of SUI in was also evaluated,7,8 but definitive superiority for
women, physicians must discuss the specific one approach over the other has not been found.
risks and benefits of mesh as well as the Transobturator mid urethral synthetic sling. The
alternatives to a mesh sling. (Clinical principle) TMUS was developed in an effort to simplify and
The Panel believes that patients considering even minimize the complication profile realized with
surgical intervention should be counseled thor- the retropubic approach by avoiding the need to
oughly regarding the use of synthetic mesh to treat traverse the retropubic space. Single and multi-
SUI. The focus should be on the benefits, the center prospective and retrospective studies have
potential risks and the FDA (U. S. Food and Drug confirmed efficacy with success rates ranging
Administration) safety communication regarding between 43 and 92% in follow-up of up to 5 years.
MUS, thereby allowing the patient to make a goal- Short-term analyses demonstrated statistical
oriented, informed decision as to how she would equivalence between RMUS and TMUS; however,
like to approach her SUI treatment. slight advantages toward the RMUS were seen with
longer follow-up (five years).9
Treatment Single incision synthetic sling. In another devel-
11. In patients with SUI or stress-predominant opment toward simplification of the synthetic sling,
MUI, physicians may offer the following non- the SIS was introduced as a less invasive, lower
surgical treatment options: (Expert Opinion) morbidity surgery with the potential to maintain
efficacy of the synthetic sling. Overall evidence on
Continence pessary effectiveness favors RMUS over SIS, but most of
Vaginal inserts the SIS trials involved TVT-Secur, which is a
Pelvic floor muscle exercises device that has since been withdrawn from the
market for poor results. The average study quality
Patients may opt for the use of conservative
was moderate, and a five-study meta-analysis indi-
measures to treat SUI or stress-predominant MUI.
cated a twofold difference in success rates in favor
There are no comparative or direct observational
of RMUS.10 Comparison of SIS and TMUS have
data concerning the use of urethral plugs, conti-
been performed in both index and non-index
nence pessaries or vaginal inserts in the manage-
patients. Taken in aggregate, the overall results
ment of these patients. The Panel believes these are
show equivalence with the available SIS and TMUS
low-risk options to consider in the treatment of
with regard to effectiveness and sexual function,
patients.
although the trials are primarily of lower level
12. In index patients considering surgery
evidence.
for SUI, physicians may offer the following
options: (Strong Recommendation; Evidence Autologous fascia pubovaginal sling. The autolo-
Level: Grade A) gous fascia PVS, which involves the placement of
autologous fascia lata or rectus fascia beneath the
MUS (synthetic) urethra to provide support, has been performed
Autologous fascia PVS for several decades. Using varying definitions,
Burch colposuspension single center studies have confirmed between 85%
Bulking agents and 92% success with 3-15 years of follow-up.11e13
The SISTEr trial compared the fascial sling to
Choice of intervention should be individualized the Burch colposuspension, and data suggest
based upon the patients symptoms, the degree of effectiveness and need for re-treatment favoring
bother the symptoms cause the patient, patient the fascial sling over the Burch colposuspension
goals and expectations, and the risks and benefits (66% versus 49%).14
for a given patient. Colposuspension. While largely supplanted by MUS,
Mid urethral synthetic sling. MUS may be charac- the suture-only based colposuspension still has a role
terized as retropubic (top-down or bottom-up), in the management of SUI. Many would consider
transobturator (inside-out or outside-in), single this primarily for patients concerned with the use
incision sling or adjustable sling types. of mesh or who are undergoing concomitant open
Retropubic mid urethral synthetic sling. Initially or minimally invasive (laparoscopic or robotic)
introduced as a bottom-up retropubic approach in abdominal-pelvic surgery, such as hysterectomy.
the late 1990s, the TVTTM is arguably the most Comparative studies of the Burch colposuspension
widely studied anti-incontinence procedure, with with the TVTTM showed essentially equivalent
880 SURGICAL TREATMENT OF FEMALE STRESS URINARY INCONTINENCE
outcomes with the TVTTM in several RCTs. The approach and voiding dysfunction occurring more
SISTEr trial compared the Burch colposuspension frequently with the inside-out approach.20e24
with the autologous fascial PVS. This comparison
had outcome data to five years and favored b. When performing RMUS in women with
the autologous fascia PVS over the Burch stress-predominant urinary incontinence, sur-
colposuspension due to the lower re-treatment rates. geons may perform either the bottom-up or the
top-down approach.
Bulking agents. The Panel believes that bulking
agents are viable treatments for SUI; however, Most studies comparing the top-down to the
little long-term data exist for them. Re-treatment bottom-up technique demonstrated equivalence or
tends to be the norm for bulking agent therapy, were inconclusive. The systematic review by Ford
and there are inadequate data to allow the et al detected a statistically significant difference
recommendation of one injectable agent over in the subjective cure rates favoring the bottom-
another. up approach; however, the relative risks for both
13. In index patients who select MUS sur- the subjective and objective cure rates fell within
gery, physicians may offer either the RMUS or the equivalence range. The top-down approach
TMUS. (Moderate Recommendation; Evidence had higher rates of bladder and urethral perfo-
Level: Grade A) ration, voiding dysfunction, and vaginal tape
The selection of RMUS versus TMUS should be erosion while an analysis of other adverse events
determined by the surgeon based on comfort or such as perioperative complications, de novo
preference and degree of urethral mobility after urgency or urgency incontinence and detrusor
discussion with the patient regarding the difference overactivity was inconclusive due to wide confi-
in risks of adverse events between each procedure. dence intervals.
A large systematic review including 55 trials with 14. Physicians may offer SIS to index
a total of 8,652 patients with SUI or stress- patients undergoing MUS surgery with the
predominant MUI showed similar rates of subjec- patient informed as to the immaturity of
tive and objective cure between TMUS and RMUS evidence regarding their efficacy and safety.
in the short term (up to 1 year).7 (Conditional Recommendation; Evidence
A meta-analysis of six trials measuring Urogen- Level: Grade B)
ital Distress Inventory scores found a statistically SIS products were introduced into the market
significant weighted mean difference favoring since the last review and have continued to evolve
TMUS slings (2.28, 95% CI: 1.77 to 2.80).15 Meta- over time leading to inconsistent evidence regarding
analyses of other instrument scores (Incontinence their efficacy and safety. Nambiar et al included 20
Impact Questionnaire Visual Analog Scale, Inter- trials that compared adverse events between SIS
national Consultation on Incontinence Question- and either inside-out or outside-in TMUS.10 After
naire Short Form and Urinary Incontinence removing the 8 trials that utilized TVT-Secur as
Severity Score)16e19 found no significant between- the SIS, the remaining 12 trials were inconclusive
group differences. with regard to efficacy.
RMUS has been associated with more major The literature regarding adverse events
vascular or visceral injuries, bladder or urethral following SIS is inconsistent. In one study, data
perforations, voiding dysfunction and suprapubic regarding four specific adverse events favored
pain, while groin pain, repeat incontinence surgery TMUS over SIS: less vaginal mesh exposure, less
between one and five years, and repeat incontinence mesh perforation into the bladder or urethra,
surgery after more than five years were more likely greater need for repeat SUI surgery and greater
to occur with the TMUS.7 need for any other additional or new surgical pro-
cedure. In contrast, meta-analyses of these same
a. When performing TMUS in women with
outcomes comparing TMUS and SIS were incon-
stress-predominant urinary incontinence, sur-
clusive. While both postoperative and long-term
geons may perform either the in-to-out or out-
pain and discomfort favored SIS when compared
to-in TMUS technique.
to TMUS, for all other outcomes, meta-analyses
Data from 10 RCTs of both index and non-index were inconclusive.
patients are consistent in finding equivalence 15. Physicians should not place a mesh sling
between the two approaches. Subjective and objec- if the urethra is inadvertently injured at the
tive cure at various follow-up times indicated time of planned MUS procedure. (Clinical
equivalence between the procedures. Adverse Principle)
events were different with vaginal perforation Given the risks of mesh erosion, the Panel felt
occurring more frequently with the outside-in that in cases where the urethra has been entered
SURGICAL TREATMENT OF FEMALE STRESS URINARY INCONTINENCE 881
unintentionally, mesh procedures for SUI should be prior vaginal surgery, severe atrophy) may be at
avoided. If the surgeon feels it is appropriate to increased risk for complications following synthetic
proceed with sling placement in the face of an mesh placement.
inadvertent entry into the urethra, then a non- 20. In patients undergoing concomitant sur-
synthetic sling should be utilized. gery for pelvic prolapse repair and SUI, physi-
16. Physicians should not offer stem cell cians may perform any of the incontinence
therapy for stress incontinent patients outside procedures (e.g., MUS, PVS, Burch colposus-
of investigative protocols. (Expert Opinion) pension). (Conditional Recommendation; Evi-
The Panel recognizes that stem cell therapy may dence Level: Grade C)
be a future option for women with SUI; however, SUI may coexist with POP in many patients.
there are currently not enough data to support this Physicians may choose to perform a concomitant
treatment modality. incontinence procedure when repairing POP;
however, they must balance the benefits with the
Special Cases potential for an unnecessary surgery and possible
17. In patients with SUI and a fixed, immobile additional morbidity.26,27
urethra (often referred to as intrinsic 21. Physicians may offer patients with SUI
sphincter deficiency) who wish to undergo and concomitant neurologic disease affecting
treatment, physicians should offer PVS, RMUS lower urinary tract function (neurogenic
or urethral bulking agents. (Expert Opinion) bladder) surgical treatment of SUI after
Some argue that a MUS should be avoided in a appropriate evaluation and counseling have
patient with an immobile urethra as the immobile been performed. (Expert Opinion)
urethra may require additional tension on the sling, Issues such as incomplete emptying, detrusor
which should be avoided when using mesh slings. overactivity and impaired compliance should be
Nevertheless, in situations in which a MUS is being identified and in many cases treated prior to surgi-
considered, some data suggest that the RMUS is cal intervention for SUI. In a patient who requires
preferred over the TMUS.25 intermittent catheterization, one must be cognizant
The Panel believes that in the case of a minimally of possible complications with the use of a bulking
mobile urethra, RMUS or PVS may a preferred agent or a synthetic sling. Patients with neurogenic
option, and in the case of the non-mobile urethra, lower urinary tract dysfunction who undergo sling
PVS may be the preferred option. procedures in particular should be followed long
Bulking injections have been shown to be effec- term for changes in lower urinary tract function.
tive in this setting as well; however, the risk of SUI 22. Physicians may offer synthetic MUS, in
recurrence and the likely need for future injections addition to other sling types, to the following
should be discussed with the patient. patient populations after appropriate evalua-
18. Physicians should not utilize a synthetic tion and counseling have been performed:
MUS in patients undergoing concomitant (Expert Opinion)
urethral diverticulectomy, repair of ure-
throvaginal fistula or urethral mesh excision Patients planning to bear children
and SUI surgery. (Clinical Principle) Diabetes
It is a well-accepted principal that synthetic Obesity
mesh should not electively be placed in close prox- Geriatric
imity to a fresh opening into the genitourinary tract.
Mesh placed near or adjacent to a concurrent ure- Overall, there does appear to be a relatively high
thral incision can theoretically affect wound heal- rate of SUI recurrence following delivery, indepen-
ing, potentially resulting in mesh perforation. dent of mode of delivery, among women with a his-
19. Physicians should strongly consider tory of MUS. In light of the elective nature of the
avoiding the use of mesh in patients under- surgery, the Panel suggests that in most instances,
going SUI surgery who are at risk for poor surgical treatment of SUI should be deferred until
wound healing (e.g., following radiation ther- after child bearing is complete.
apy, presence of significant scarring, poor Diabetic women planning to undergo sling sur-
tissue quality). (Expert Opinion) gery should be counseled regarding their higher
Proper healing of the vaginal epithelium is crit- risk for mesh erosion and reduced effectiveness
ical in the prevention of mesh exposures. Compro- compared with their non-diabetic counterparts.28e33
mised tissue may heal poorly, thereby increasing There appears to be a slight correlation suggest-
the risk for complications when mesh is placed. ing worse clinical effectiveness of slings in obese
Patients with poor tissue characteristics (e.g., patients compared with those with lower body mass
following radiation therapy, significant fibrosis from index.28,34e37
882 SURGICAL TREATMENT OF FEMALE STRESS URINARY INCONTINENCE
Geriatric patients should be counseled that they Urological Association Education and Research,
are at lower likelihood of successful clinical out- Inc., which was created in 2015. The Practice
comes compared with younger patients. Guidelines Committee (PGC) of the AUA selected
the committee chair. Panel members were selected
Outcomes Assessment by the chair. Membership of the Panel included
23. Physicians or their designees should specialists in urology with specific expertise on this
communicate with patients within the early disorder. The mission of the Panel was to develop
postoperative period to assess if patients recommendations that are analysis-based or
are having any significant voiding problems, consensus-based, depending on Panel processes and
pain, or other unanticipated events. If available data, for optimal clinical practices in the
patients are experiencing any of these out- treatment of stress urinary incontinence.
comes, they should be seen and examined. Funding of the Panel was provided by the AUA
(Expert Opinion) and SUFU. Panel members received no remunera-
Early intervention may ameliorate potential tion for their work. Each member of the Panel pro-
complications in patients who have had SUI sur- vides an ongoing conflict of interest disclosure to
gery. Because patients may not recognize some of the AUA.
the potential adverse events that can occur, they While these guidelines do not necessarily estab-
may suffer unnecessarily if the appropriate ques- lish the standard of care, AUA seeks to recommend
tions and assessment are not performed. Though and to encourage compliance by practitioners with
clearly this communication can be in person, there current best practices related to the condition being
is no evidence that a phone discussion cannot pro- treated. As medical knowledge expands and tech-
vide the same information.38 nology advances, the guidelines will change. Today
24. Patients should be seen and examined these evidence-based guidelines statements repre-
by their physicians or designees within six sent not absolute mandates but provisional pro-
months postoperatively. Patients with unfa- posals for treatment under the specific conditions
vorable outcomes may require additional described in each document. For all these reasons,
follow-up. (Expert Opinion) the guidelines do not preempt physician judgment
in individual cases.
The subjective outcome of surgery as Treating physicians must take into account vari-
perceived by the patient should be assessed ations in resources, and patient tolerances, needs,
and documented. and preferences. Conformance with any clinical
Patients should be asked about residual in- guideline does not guarantee a successful outcome.
continence, ease of voiding/force of stream, The guideline text may include information or rec-
recent urinary tract infection, pain, sexual ommendations about certain drug uses (off label)
function and new onset or worsened OAB that are not approved by the U. S. Food and Drug
symptoms. Administration (FDA), or about medications or
A physical exam, including an examination substances not subject to the FDA approval process.
of all surgical incision sites, should be per- AUA urges strict compliance with all government
formed to evaluate healing, tenderness, mesh regulations and protocols for prescription and use of
extrusion (in the case of synthetic slings) these substances. The physician is encouraged to
and any other potential abnormalities. carefully follow all available prescribing information
A PVR should be obtained. about indications, contraindications, precautions
A standardized questionnaire (e.g. PGI-I) and warnings. These guidelines and best practice
may be considered. statements are not intended to provide legal advice
about use and misuse of these substances.
Although guidelines are intended to encourage
FUTURE DIRECTIONS best practices and potentially encompass available
All future therapies will need to be carefully vetted technologies with sufficient data as of close of the
and assessed for safety and efficacy, and it is hoped literature review, they are necessarily time-limited.
that enhanced collaboration between regulatory, Guidelines cannot include evaluation of all data on
academic and patient outcomes groups will provide emerging technologies or management, including
continued improvement in interventions for SUI. those that are FDA approved, which may immedi-
ately come to represent accepted clinical practices.
For this reason, the AUA does not regard technolo-
DISCLAIMER gies or management which are too new to be
This document was written by the Stress Urinary addressed by this guideline as necessarily experi-
Incontinence Guideline Panel of the American mental or investigational.
SURGICAL TREATMENT OF FEMALE STRESS URINARY INCONTINENCE 883
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