UROLOGIC SURGERY IN WOMEN: ADVICE FROM THE EXPERTS
From The 2007 Kaiser Permanente Urology Symposium
Educational Objectives
| The goal of this program is to improve the management of stress urinary incontinence (SUI) and cystocele. After hearing and
assimilating this program, the clinician will be better able to:
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 | 1. Compare currently used procedures for management of SUI, including the tension-free vaginal tape (TVT) procedure,
the Burch procedure, and transobturator procedures.
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| 2. Discuss the outcomes, safety, and complications of midurethral sling procedures.
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| 3. Summarize the technical challenges involved in correction of pelvic organ prolapse.
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| 4. Contrast the properties of biologic and synthetic materials used in pelvic reconstruction.
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| 5. Interpret the published data on various approaches to pelvic reconstruction.
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Faculty Disclosure
In adherence to ACCME Standards for Commercial Support, Audio-Digest requires all faculty and members of the planning
committee to disclose relevant financial relationships within the past 12 months that might create any personal conflicts of interest.
Any identified conflicts were resolved to ensure that this educational activity promotes quality in health care and not a
proprietary business or commercial interest. For this program, the faculty and planning committee reported nothing to disclose.
Acknowledgements
Drs. Lemack and Winters gave their lectures at the 2007 Kaiser Permanente Urology Symposium, sponsored by the
Southern California Permanente Medical Group, and held October 5-7, 2007, in Westlake Village, CA. The Audio-
Digest Foundation thanks the speakers and the Southern California Permanente Medical Group for their cooperation
in the production of this program.
| MIDURETHRAL SLINGS —Gary Lemack, MD, Associate Professor of Urology and Neurology, University of Texas
Southwestern Medical Center, Dallas
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Retropubic Procedures
| Tension-free vaginal tape (TVT): gold standard for stress incontinence; level I evidence; tries to recreate pubourethral
ligament complex
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| Studies: Ward et al—randomized controlled trial (RCT) comparing TVT to Burch bladder neck suspension (effective
and safe, but larger procedure with bigger incision); in 2 yr, 81% of patients with TVT and 80% of those with Burch
had negative pad test (objective measure of success); on questionnaire, 25% of Burch group and 20% of TVT group reported
no leakage at any time; by subjective measures, TVT better than Burch (SF-36 Health Survey scores higher);
meta-analysis (European Urology, 2008)—RCTs or large studies; looked at overall cure rate for TVT vs Burch;
trend toward TVT being better than Burch, although some studies favored Burch; meta-analysis comparing TVT to
pubovaginal sling found no dramatic difference; safety (speaker’s experience)—bladder perforation (5%-10%); retropubic
hematoma (undefined); vaginal extrusion of mesh (≈1%); urinary tract infection (UTI; ≈1%)
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| TVT vs suprapubic arch (SPARC) sling system: meta-analysis found TVT “somewhat superior” in efficacy; safety—
little difference between 2 methods; bladder perforation rate somewhat higher (patient outcome not affected); retropubic
hematoma about same; extrusion rate slightly higher; UTI rate similar; choice depends on comfort level of surgeon
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| Other complications: rare but disastrous; bowel perforations and obstructions underreported; arterial perforations and
need for immediate vascular intervention; ≥8 deaths attributed to midurethral sling (MUS; not many, considering thousands
of procedures done); however, for quality-of-life (QOL) procedure, any death warrants close examination; complications
likely underreported and underestimated
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Other Procedures
| Distal urethral polypropylene sling: similar to TVT and SPARC but uses different (less costly) material; subvaginal
pocket created; postoperative daily pad use substantially improved; QOL and other assessments similar to that seen with
TVT; 5-yr data—68 patients; 93% had ≤1 episode of stress incontinence per day; ≈7% had de novo urge incontinence;
no prolonged voiding dysfunction; no patients had sling removed
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| Role of urodynamics in patient evaluation: value of Valsalva leak point pressures (LPPs) controversial; study
found patients with lower LPPs preoperatively had more leaks per week, but no difference postoperatively, ie, distal urethral
polypropylene sling works similarly, regardless of LPP; unknown whether due to superiority of procedure or because
LPP does not give information on type of incontinence
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| Transobturator procedures: efficacy—meta-analysis looking at TVT vs transobturator tape (TOT) shows no clear
difference in efficacy; out-to-in vs in-to-out—retropubic and obturator TVT (TVT-O) have similar success rates, although
operating times different; safety—bladder perforation less with TOT; urethral perforation may occur; vaginal perforations,
bowel injuries, and extrusions seem less common, but probably underreported; several cases of side and groin pain, groin
abscesses, and ongoing severe pain; unexplained vaginal pain, worsened incontinence, and dyspareunia; ongoing follow-up
and evaluation for extrusion indicated; vaginal extrusion—seems highest with TOT (unwoven thermally bonded polypropylene
material [since replaced]); fewest extrusions with knitted monofilament polypropylene found in TVT-O and now in
most products
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| Transobturator or retropubic? some initial evidence that patients lacking urethral hypermobility do not do as well with
TOT; trajectory of sling and direction of forces different (more up-and-down, ie, anteroposterior, with TVT and more lateral
with TOT); large-scale comparison studies under way, with results expected in ≈2 yr
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| Complications: transobturator approach favored overall in reported studies; voiding dysfunction (mean values)—
percentage requiring catheterization not much different but slightly higher with SPARC approach; percentage requiring
transection slightly lower with TOT; percentage with de novo urgency definitely lower with TOT
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| National Institutes of Health (NIH) studies under way: part of Urinary Incontinence Treatment Network; 1) pubovaginal sling
vs Burch bladder neck suspension; 2) tolterodine with or without biofeedback for urge incontinence; 3) TVT vs TOT; all patients
had urodynamic studies to which all investigators blinded
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| Summary: TVT and TOT similar in efficacy; pubovaginal sling effective as well; TVT, TOT, and pubovaginal sling
more effective than Burch procedure; complications infrequent but disastrous when they occur; unresolved issues—
preoperative predictors of which patients might benefit from which procedures; usefulness of urodynamics; long-term
impact on voiding (pressure changed by retropubic procedures); effectiveness for mixed incontinence; how to train physicians
in new procedures
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| CYSTOCELE REPAIR: TECHNIQUES AND GRAFT MATERIALS —Jack C. Winters, MD, Professor and Chair, Department
of Urology, Louisiana State Health Sciences Center, New Orleans
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| Prolapse: caused by lack of suspensory support, due to poor connective tissue and comprehensive neuromuscular dysfunction;
not just anterior compartment, but also posterior and apical; although patients may present with complaints of
lower urinary tract symptoms (LUTS, eg, incontinence), prolapse caused by complex multicompartment defects;
symptoms—storage abnormalities, eg, detrusor overactivity; emptying disorders, eg, incontinence due to impaired urethral
resistance; demographic—rising; in one population, risk for prolapse surgery ≈11% before 80 yr of age, and repeat
surgery needed in >33% of these
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| Technical challenges: graft materials—data on biologic materials available from pubovaginal sling as well as orthopedic
procedures; in prolapse, end point not only improvement of incontinence, but also maintenance of pelvic organ
support in multiple compartments; variance of biologic materials leads to variations in outcomes; allografts—harvesting
and transplantation of tissues; packaging, processing, and sterilization proprietary; same type of tissue may be treated by
various methods, eg, freeze drying, irradiation; potential for disease transmission because processed tissue retains antigens
and DNA from donor; ability of tissue to remodel, which adds host antigens, determines long-term success of graft;
xenografts—most commonly used now due to 1) cadaveric material often in short supply; 2) process more standardized;
3) material more readily available
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| Why biologic materials fail: rupture; rejection; dissolution or degeneration; lack of revitalization and remodeling by
host (also problem with synthetic materials); rupture—force vectors placed on tissue in pelvis unknown; no evidence to
suggest failure due to graft breakage; rejection—little evidence, except when severe infection present; inflammatory
cells from generalized inflammatory reaction, not rejection; dissolution or degeneration—most common finding with
failed allografts; encapsulation—tissue walled of; no cellular ingrowth; remodeling—graft must have substrate that
promotes integration of host tissues; arrangement of collagen fibers must allow host to deposit tissue into graft; irradiating,
freezing, or other processing of graft affects arrangement
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| Synthetic materials: gross visible host tissue integration into mesh as in biologic materials; mesh becomes “bioaccepted”;
case for synthetics—variability and other unknowns of biologic material; ability of mesh to become bioaccepted; ready
availability and lower cost of synthetic materials; no potential for disease transmission; favorable tensile strength
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| Amid classification: type I meshes—polypropylene; several configurations and pore sizes; macroporous monofilament,
ie, loosely woven mesh, desirable for prolapse surgery; large openings promote host tissue integration and allow host
defenses to prevent bacterial infiltration; other types, eg, Mersilene, Marlex, Teflon, Gore-Tex—some have large
pore sizes, but multifilament, ie, promote bacterial penetration into mesh
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Pelvic Reconstruction
| Anterior compartment: abdominal and vaginal approaches; 1) anterior repair; 2) paravaginal repair (done abdominally
or vaginally); 3) 4-corner repair
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| Anatomic concepts: bladder rests on pubocervical fascia, which must remain intact and connected to intact apex to
achieve level anterior support; increasing pressure and forces lead to break in pubocervical fascia, leading to midline
central defect, ie, separation of fascia, that allows herniation of bladder and appearance of distention
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| Anterior colporrhaphy: lateral and apical attachments must be intact; traditional—involves reducing hernia in midline and
plicating pubocervical fascia with sutures; anterior repair with grafts—onlay graft of absorbable mesh not successful;
suturing of graft to lateral pelvic sidewall as well as to contralateral pelvic sidewall results in double repair (lateral and anterior)
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| Paravaginal repair: entry into retropubic space allows placement of stabilizing sutures into arcus tendineus fasciae pelvis
or fascia of obturator internus on both sides; addition of midline repair results in lateral and midline correction;
caveats—if apex not connected to level I support, problems may arise; procedure may involve more bleeding, and patients
may experience more LUTS; technical pearls—if incorporating patch, midline or flap incision preferred; Miya
hooks or Capio device helpful; advantages of paravaginal repair—ability to continue to multicompartment repair,
ie, place sutures into sacrospinous ligament or near ischial spine, allowing stabilization of cuff of vagina
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| Isolated paravaginal defects: if pubocervical fascia intact, break from arcus visualized from above and repaired laparoscopically,
abdominally, or vaginally; place multiple interrupted sutures from vaginal sidewall to arcus to reestablish
lateral support
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| Approach: ideally, perform physical examination to determine type of defect, then perform repair specific to defect; in reality,
limitations of physical examination and diagnostic adjuncts prevent this approach; consider how best to handle
defect(s) present in each patient, based on skill sets of surgeon and team
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Interpretation of Data
| Problems: no standardization in diagnosis, technique, or outcome reporting
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| Anterior colporrhaphy (Weber, 2001): 2-yr prospective randomized trial; standard repair; ultralateral technique
(aggressive plication to greatly reduce anterior compartment laterally); ultralateral technique plus mesh; found no technique
truly superior; with mesh, 46% success rate at 2 yr; however, majority of patients reported improved symptoms;
other authors report overall success rate of ≈66% with standard repair
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| Tissue-reinforced repair: vaginal-paravaginal technique; recurrence rate 2% to 19%
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| Earlier data: paravaginal repair with biologic material—few studies, small number of patients, and short follow-up;
results better than with traditional anterior repair, but numbers decline at intermediate times, suggesting inherent deficiency
in graft material that may predispose to failure; cap procedure? Leach reported 60% recurrence rate for stress incontinence;
some had recurrence of cystocele, but symptom recurrence low; Handel et al, Journal of Urology, 2007—looked at 3
procedures; porcine dermis graft had highest recurrence rate and complications; patients who had anterior repair with mesh
seemed to do better
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| Total mesh reconstruction: components—lateral support (arcus or pelvic sidewall); distal urethral support (sling or
another suture placed distally); proximal support (cuff, sacrospinous ligament, or iliococcygeal fascia); thus providing total
mesh support for anterior compartment and apex; may also be extended posteriorly for complete mesh repair of vagina;
methods—kit; free graft and placement of point sutures in arcus and sacrospinous ligament; both achieve total mesh reconstruction
of pelvic floor; outcomes—trend in favor of mesh over biologic material; data longer-term with larger number
of patients; complications—≤13% incidence of mesh exposure; dyspareunia; pelvic pain
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| Kits for total mesh repair: perform full-thickness vaginal wall dissection; enter retropubic space and move toward ischial
spine; for prolapse, also expose sacrospinous ligament; surgical skill required; kit does not provide shortcut, only delivery
system
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| Abstracts from International Urogynecological Association (IUGA): success rates good, but data <6 mo; extrusions and
recurrences (eg, 1 surgeon reported 33 recurrences in 300 patients at 6 mo); incidence of mesh issues 3.2%; French
group reported 4.3% failure rate in 106 patients at 3 mo and 5 serious complications, 4 of which required reoperation
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| Erosions: with total-mesh procedures, extrusion of material through vaginal wall more likely than erosions; prolapse
repairs—with original suture repair, erosion rates 8.3% to 11.0%; with kit, initial erosion rate ≈18%, but number decreasing
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| Dyspareunia: in one study, ≤63% incidence with posterior mesh, and 20% with anterior compartment mesh
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| MUS in advanced cystocele: arguments for—20% to 30% of patients also have stress incontinence; no reliable way
to test urodynamics before surgery; MUS procedure easy, with minimal morbidity; patient will not go into retention; reduces
rate of repeat cystocele procedures; level I evidence that Burch procedure should be done during abdominosacral
colpopexy; arguments against—majority of women who do not complain of leakage do not have it; LUTS in women
with cystocele may be obstructive; some women “Valsalva voiders” who would do poorly with sling; most data on slings
for protection against recurrent cystocele for bladder neck slings, not MUS; speaker’s approach—reduce prolapse; look
for leakage and inform patient of findings; if leakage not present, let patient decide; in women with obstructive symptoms,
MUS not placed; MUS placed only if patient leaks before cystocele surgery
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| Comparison studies: RCTs produced level I evidence that abdominosacral colpopexy should be done with synthetic material;
no level I evidence to suggest that any material needed in vaginal surgery; American Urological Association
data—suggest that grafts better for anterior compartment, but no RCTs; kits cost more and have higher incidence of apical
prolapse; data suggest that apical suspensions successful laparoscopically and robotically, but distal defects must be addressed
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| Concluding remarks: functional implications of total mesh repair unknown; no level I evidence to justify putting mesh or
biologic material in every woman undergoing prolapse repair
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Suggested Reading
Abdel-Fattah M et al: Retrospective multicentre study of the ne. minimally invasive mesh repair devices for pelvic
organ prolapse. BJOG 115:22, 2008; Albo ME et al: Burch colposuspension versus fascial sling to reduce urinary
stress incontinence. N Engl J Med 356:2143, 2007; Blanchard KA et al: Recurrent pelvic floor defects after abdominal
sacral colpopexy. J Urol 175:1010, 2006; Boyles SH et al: Dyspareunia and mesh erosion after vaginal mesh
placement with a kit procedure. Obstet Gynecol 111:969, 2008; Culligan PJ et al: A randomized controlled trial
comparing fascia lata and synthetic mesh for sacral colpopexy. Obstet Gynecol 106:29, 2005; Dubuisson JB et al:
Treatment of genital prolapse by laparoscopic lateral suspension using mesh: a series of 73 patients. J Minim Invasive
Gynecol 15:49, 2008; Frederick RW et al: Cadaveric prolapse repair with sling: intermediate outcomes with 6
months to 5 years of followup. J Urol 173:1229, 2005; Handel LN et al: Results of cystocele repair: a comparison of
traditional anterior colporrhaphy, polypropylene mesh and porcine dermis. J Urol 178:153, 2007; Jakus SM et al: Biologic
and synthetic graft use in pelvic surgery: a review. Obstet Gynecol Surv 63:253, 2008; Maher C et al: Surgical
management of pelvic organ prolapse in women: a short version Cochrane review. Neurourol Urodyn27:3, 2008;
Nager CW et al: Urodynamic measures do not predict stress continence outcomes after surgery for stress urinary incontinence
in selected women. J Urol 179:1470, 2008; Novara G et al: Complication rates of tension-free midurethral
slings in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of randomized
controlled trials comparing tension-free midurethral tapes to other surgical procedures and different devices. Eur Urol
53:288, 2008; Nguyen JN et al: Outcome after anterior vaginal prolapse repair: a randomized controlled trial. Obstet
Gynecol 111:891, 2008; Phillip HE: Low-weight polypropylene mesh for anterior vaginal wall prolapse: a randomized
controlled trial. Obstet Gynecol 111:452, 2008; Ridgeway B et al: The use of synthetic mesh in pelvic reconstructive
surgery. Clin Obstet Gynecol 51:136, 2008; Waltregny D et al: TVT-O for the treatment of female stress
urinary incontinence: results of a prospective study after a 3-year minimum follow-up. Eur Urol 53:401, 2008; Ward
RM et al: Vaginal paravaginal repair with an AlloDerm graft: Long-term outcomes. Am J Obstet Gynecol 197:670,
2007.
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