Stress Urinary Incontinence: Advances of Surgical Management

1
Stress Urinary IncontinenceAdvances of Surgical
Management

• Eugene Kaplan, MD
• Center for Advanced Gynecologic Surgery
• and Pelvic Floor Medicine

2
Stress Urinary IncontinenceAdvances of Surgical
Management
AN INCONTINENT MOMENT
OR
A LITTLE DRY HUMOR AMONG FRIENDS
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SUI - Is the Most Common Type of UI in Women
Stress Urinary IncontinenceAdvances of Surgical
Management
Hampel C, et al. Urology. 199750 (suppl
6A)4-14.
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US Prevalence of SUI Symptoms
Stress Urinary IncontinenceAdvances of Surgical
Management

• In total, 34 million women suffer from SUI
  symptoms1
• Equivalent to the population of California2

1. NFO Migliara/Kaplan August, 2001. Research
funded by Eli Lilly and Company. 2. US Census
Bureau. Electronic Citation 2001.
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Stress Urinary IncontinenceAdvances of Surgical
Management
Surgeries for SUI in the United States

• Incontinence1 - 1998 135,000 procedures

• Waetjen LE. Ob Gyn. 2003101(4)671-676.
• (Data from national hospital discharge surveys)

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Cost Statistics
Stress Urinary IncontinenceAdvances of Surgical
Management

• Cost to U.S. health care system is more than 15
  BILLION annually
• Of this amount, approximately 250 million is
  spent on medical devices

1. May 2002, Medical Data International, HIS
Health Group
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Stress Urinary IncontinenceAdvances of Surgical
Management
Cost Statistics

• Cost To Patient
• - 1000/year in absorbent products,
• laundry, clothes1,2

1. Read Karens Story Cure your incontinence
today! www.womenneedtoknow.com (AHCPR, 1996) 2.
Wilson, Leslie, et al. Annual Direct Cost of
Urinary Incontinence, The American
College of Obstetricians and Gynecologists. Vol.
98, No. 3, p398-406, Sept 2001.
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Stress Urinary IncontinenceAdvances of Surgical
Management
ICS - DEFINITION OF URINARY INCONTINENCE
The objective loss of urine that presents a
social or hygienic problem to the individual.
Incontinence is not a normal part of aging nor is
it a disease.
Abrams P et al. Urology. 200361(1)37-49.
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Stress Urinary IncontinenceAdvances of Surgical
Management
ICS - DEFINITION OF STRESS URINARY INCONTINENCE
Symptom Involuntary leakage on effort or
exertion, or on sneezing or
coughing Sign Involuntary leakage from
the urethra synchronous with exertion, chough...
Urodynamic observations Involuntary leakage
during increased abdominal pressure w/o
detrusor contractions
Abrams P et al. Urology. 200361(1)37-49.
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Stress Urinary IncontinenceAdvances of Surgical
Management
STRESS INCONTINENCE

• Failure of urethra to maintain water-tight seal
  during stress conditions
• Basic mechanisms of failure
• - poor urethral support
• - intrinsic sphincter deficiency

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ETIOLOGIC FACTORS FOR SUI
Stress Urinary IncontinenceAdvances of Surgical
Management

• Anatomic and neurological injury of the pelvic
  floor during childbirth
• Genetic susceptibility (tissue strength)
• Behavioral aspects (smoking, obesity, occupation)
  
• Confounding medical conditions (chronic pulmonary
  disease, aging, estrogen deficiency)

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Stress Urinary IncontinenceAdvances of Surgical
Management
SIZE DOES MATTER
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Stress Urinary IncontinenceAdvances of Surgical
Management
EFFECTS OF CHILDBIRTH

• Prospective study¹ 305 primiparas
• - 32 SUI during pregnancy
• - 19 of continent after delivery ? develop SUI
  5 years later
• - ? with SUI 3 months postpartum - 92 had
  SUI 5 years later
• Prospective study² 344 nulliparous pregnant
  women - 2 groups
• - vaginal delivery group (VD) - 18 times higher
  risk of having SUI in year
• postpartum than cesarean delivery group
  (CD)

• Vikrup L, et al. Obstet Gynecol 1992 79 945-9.
• Int Urogynecol J Pelvic Floor Dysfunct. 2007
  Feb18(2)133-9

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Stress Urinary IncontinenceAdvances of Surgical
Management

• FUNCTIONAL UNIT
• Connective tissue
• Pelvic muscles
• Nerves

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Stress Urinary IncontinenceAdvances of Surgical
Management

• FUNCTIONAL UNIT
• Connective tissue
• Pelvic muscles
• Nerves

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Stress Urinary IncontinenceAdvances of Surgical
Management
EFFECTS OF CHILDBEARING Connective tissue
disruption
DeLancey J., Clinical Obstet and Gynecol, Vol 33,
No.2, June 1990 Peschers U., DeLancey J.,
Urethral Support and Child birth Obstet
Gynecol, Vol. 88, No 6, December 1996
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Stress Urinary IncontinenceAdvances of Surgical
Management
EFFECTS OF CHILDBEARING Levator Ani
muscle disruption
- 20 of women develop defect in Levator Ani
muscle after NSVD
DeLancey J O, Appearance of levator ani muscle
abnormalities in magnetic resonance images after
vaginal delivery Obstet Gynecol, 2003101
46-53
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Stress Urinary IncontinenceAdvances of Surgical
Management
EFFECTS OF CHILDBEARING Neurological
injury
Snook SJ, Swash M, et al, The effect of vaginal
delivery on pelvic floor a 5-year follow up. Br
J Surg 1990 77 1358-60
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Stress Urinary IncontinenceAdvances of Surgical
Management
MAKING A DIAGNOSIS Q-tip Test

• - Exaggerated, upward angle of gt12 degrees at
  rest and gt30 during
• Valsalva is considered evidence of urethral
  hypermobility

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Stress Urinary IncontinenceAdvances of Surgical
Management
MAKING A DIAGNOSIS Cystoscopy
Staskin DR. Classification of voiding
dysfunction. In Cardozo L, Staskin DR,
eds.Textbook of Female Urology and
Urogynaecology. London Isis Medical
Media200184-89.
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Stress Urinary IncontinenceAdvances of Surgical
Management
MAKING A DIAGNOSIS Urodynamic Evaluation
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AIMS OF CORRECTIVE SURGERY EVOLUTION
Stress Urinary IncontinenceAdvances of Surgical
Management

• Compress outlet (Kelly plication)
• Reposition and restore sphincter unit to higher
  intra-abdominal position (Anterior colporrhaphy)
• Restore pressure transmission differential (MMK,
  Burch
• Needle procedures)
• Provide backboard (Sling procedures)
• Coapt outlet at rest - intrinsic sphincter
  deficiency (Bulking agents)

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SURGERY FOR SUI RATIONALES
Stress Urinary IncontinenceAdvances of Surgical
Management

• Anterior repair compress/plicate/reposition/stabi
  lize
• Vaginal/Urethral Suspension Procedures
  Reposition/stabilize
• Retropubic Marshall-Marchetti-Krantz (MMK),
  Burch
• Vaginal Pereyra, Stamey, Gittes, Raz
• Sling Backboard, coaptation (for gross ISD)
• Tension-free vaginal tape (TVT) type Backboard
• Artificial urinary sphincter (AUS) Intermittent
  compression
• Bulking agents coaptation
• Radiofrequency Reposition/stabilize

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ANTERIOR COLPORRHAPHY/PLICATION
Stress Urinary IncontinenceAdvances of Surgical
Management

• ICI (2002)1
• Not normally recommended for the cure of
  stress incontinence
• COCHRANE COALITION2
• Should be restricted to women deemed unsuitable
  for alternative treatment
• Useful only for central defect cystocele

1. Abrams P et al. Incontinence. 2nd
International Consultation on Incontinence,
Paris, July 1-3, 2001. 2nd Edition, 2002. 2.
Cochrane Library, Volume 1, 2003.
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MARSHALL-MARCHETTI-KRANTZ (MMK) (1949)
Stress Urinary IncontinenceAdvances of Surgical
Management

• AUA (1997)1 - mean cure/dry
• 1-2 yr. 72 (55-85)
• 2-4 yr. 83 (75-89)
• gt 4 yr. 83 (76-88)
• ICI-22
• cure 88
• improvement 91
• primary 92
• secondary 84
• complications overall, 22 osteitis, 2.5
  mortality, 0.2

1. AUA Incontinence Clinical Guidelines Panel, J
Urol. Sept. 1997. 2. Abrams P et al.
Incontinence. Report of the 2nd International
Consultation on Incontinence, Paris, July 1-3,
2001. 2nd Edition, 2002.
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BURCH PROCEDURE (John Burch -1961)
Stress Urinary IncontinenceAdvances of Surgical
Management

• AUA (1997)1 - mean cure/dry
• 1-2 yr 85 (78-91)
• 2-4 yr 84 (79-88)
• 4 yr 83 (75-90)
• ICI-22 - follow-up, 9 mo -16 yr
• Cure/Dry 79
• Improvement 90
• With time, decrease in continence

1. AUA Incontinence Clinical Guidelines Panel, J
Urol. Sept. 1997. 2. Abrams P et al.
Incontinence. Report of the 2nd International
Consultation on Incontinence, Paris, July 1-3,
2001. 2nd Edition, 2002.
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BURCH PROCEDURE COMLICATIONS
Stress Urinary IncontinenceAdvances of Surgical
Management

• ICI-2
• Voiding dysfunction 2-27 (mean, 10.3)
• De novo DI 8-27 (mean, 17)
• Prolapse 3-27 (mean, 13.6) at 5 yr
• Mortality 0

Abrams P et al. Incontinence. Report of the 2nd
International Consultation on Incontinence,
Paris, July 1-3, 2001. 2nd Edition, 2002.
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LAPAROSCOPIC BURCH PROCEDURE
Stress Urinary IncontinenceAdvances of Surgical
Management

• ICI-2¹
• The results are conflicting until longer
  studies are available no conclusions can be drawn
  evidence suggests that the results are
  surgeon-dependent
• McDougall EM²
• The laparoscopic bladder neck suspension in 3 and
  4 years follow-up has achieved a success rate of
  only 30, with a mean time to failure of 18
  months.

• Abrams P et al. Incontinence. Report of the 2nd
  International Consultation on Incontinence,
  Paris, July 1-3, 2001. 2nd Edition, 2002
• McDougall EM . Laparoscopic management of female
  urinary incontinence Urol Clin North Am. 2001
  Feb28(1)145-9, x.

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NEEDLE SUSPENSION PROCEDURES (NSP)
Stress Urinary IncontinenceAdvances of Surgical
Management

• Pereyra (1959) rationale
• Avoid tearing out of sutures (MMK)
• Avoid opening retropubic space
• Stamey (1973)
• Cystoscopic control for suture placement/bladder
  neck closure
• Bolsters support bladder neck
• Raz (1981)
• Helical sutures for endopelvic fascia,
  periurethral tissues
• Emphasis on the good stuff

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NEEDLE SUSPENSION PROCEDURES (NSP)
Stress Urinary IncontinenceAdvances of Surgical
Management

• initial success rates are not maintained
  with time risk of failure is higher than with
  RPS few, if any, indications to perform needle
  suspension procedure¹
• AUA cure/dry rates of NSP at 4 years only
  67²
• For surgeons who are experienced in sling
  operations and can perform them with minimal
  morbidity, NS offers no significant advantages³

• Abrams P et al. Incontinence. Report of the 2nd
  International Consultation on Incontinence,
  Paris, July 1-3, 2001. 2nd Edition, 2002.
• Leach G et al. Female Stress Urinary Incontinence
  Clinical Guidelines Panel summary report on
  surgical management of female stress urinary
  incontinence J Urol 1997 158 875-80
• 3. Erickson DR. J Urol. 20011651612-1613.

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PUBOVAGINAL SLING CLASSIC
Stress Urinary IncontinenceAdvances of Surgical
Management

• Originally, compress and partially obstruct
  urethra
• high incidence of voiding dysfunction
• Provide backboard and support during effort
• for gross ISD, need to appose walls at rest

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PUBOVAGINAL SLING NEW CONCEPTS
Stress Urinary IncontinenceAdvances of Surgical
Management

• Thinking has changed
• obstruction unnecessary1
• no need to increase resting Pura unless gross ISD
  (McGuire)
• useful for support and ISD
• Classic location is bladder neck/proximal urethra
• Raz midurethra2

1. McGuire EJ and Lytton B. J Urol.
197811982-84. 2. Rodriguez LV. Curr Urol Rep.
20012399-406.
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PUBOVAGINAL SLING MATERIALS
Stress Urinary IncontinenceAdvances of Surgical
Management

• NATURAL
• Rectus fascia full-length, patch
• Fascia lata autologous, allogenic
• Dermis porcine, human
• Dura
• Other

• SYNTHETIC
• Gore-Tex
• Nylon
• Perlon
• Mersilene
• Silastic
• Polyglactin mesh
• Prolene

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PUBOVAGINAL SLING SUCCESS RATES
Stress Urinary IncontinenceAdvances of Surgical
Management

• Ranges of success more consistent than with other
  procedures
• AUA¹
• RPS and slings are most effective procedures for
  long-term success, but they are associated with
  higher complication rates and longer
  convalescence
• ICI-2²
• Effective for SUI
• Cure rate 80 improvement rate 90
• Autologous material suggested to have higher cure
  and lower complication rates, but long-term
  studies needed to see whether material influences
  outcome
• 10-year continence rate approximates 1-year rate

• Leach G et al. Female Stress Urinary Incontinence
  Clinical Guidelines Panel summary report on
  surgical management of female stress urinary
  incontinence J Urol 1997 158 875-80
• Abrams P et al. Incontinence. Report of the 2nd
  International Consultation on Incontinence,
  Paris, July 1-3, 2001. 2nd Edition, 2002

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Stress Urinary IncontinenceAdvances of Surgical
Management
PUBOVAGINAL SLING COMPLICATIONS

• Autologous grafts
• Voiding dysfunction 2-20
• Long-term Self-Cath
• 1.5-7.8
• De novo DI 3-23
• Allogenic cadaver grafts
• No higher erosion rates
• Higher long-term material failure (gt 20)

• Synthetics
• Increased risk of erosion and sinus formation?
• Vaginal erosion 0-16
• Urethral erosion 0-5
• De novo DI 4-66
• Removal or revision 1.8-35

Data compiled by ICI (2002), AUA (1997), Chaikin
and Blaivas (2001), Jensen and Rufford (2001),
Rodriguez et al (2001).
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GYNECARE TVT
Stress Urinary IncontinenceAdvances of Surgical
Management
37
TENSION-FREE VAGINAL TAPE (TVT)
Stress Urinary IncontinenceAdvances of Surgical
Management

• Introduced 1995-1996 by Ulmsten and Petros
• Knotted, monofilament, Prolene mesh,
  gt75 micron pore size, under midurethra
• Based on a integral theory (Ulmsten/Petros)
• Tape lies free at rest, not fixed
• Does not correct hypermobility
• Tape fixed by tissue incorporation/in growth
• TVT Wona Bees

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MID-URETHRAL SLINGS(Ins, Outs, Ups, Downs)
Stress Urinary IncontinenceAdvances of Surgical
Management
39
TENSION-FREE VAGINAL TAPE (TVT)
Stress Urinary IncontinenceAdvances of Surgical
Management

• Success rate open colposuspension
• Cure of SUI 65-91
• Improvement 94-97
• Follow-up 2-5 years

Data from Ulmsten et al (1990), (1998), (2000)
Kuuva and Nilsson (2000) ICI (2002) Ward and
Hilton (2002).
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TVT COMPLICATIONS
Stress Urinary IncontinenceAdvances of Surgical
Management

• Retention 2.3
• Minor voiding difficulty 7.5
• Bladder perforation 3.8
• Urinary tract infection (UTI) 4.1
• Major vessel injury 0.1
• Obturator nerve injury 0.1
• Wound infection 0.8
• Poorly healing vaginal incision 0.7

Kuuva and Nilsson (2000), Nationwide assessment
(Finland), 1455 patients.
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TRANSOBTURATOR MID-URETHRAL SLINGS
Stress Urinary IncontinenceAdvances of Surgical
Management

• INTRODUCED 2001 by Delorme E and deTayrac R¹
• RATIONAL - reduce bladder/urethral injuries
  (did not eliminate)
• ANATOMY - needles and mesh passed 4 cm away
  from obturator vessels and nerve
• APPROACH
• outside-in Monarch (AMS)
• Obtryx (Boston Scientific)
• Uretex TO (BARD Urological) etc.
• Inside-out TVT-Obturator (Ethicon)

1. Delorme et al. A new minimally invasive
method in treatment of urinary incontinence in
women, Prog Urol. 2003 13(4)656-659
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TRANSOBTURATOR MID-URETHRAL SLINGS
Stress Urinary IncontinenceAdvances of Surgical
Management

• SUCCESS cured RP - 83.9 TO 90¹
• improved RP - 9.7 TO 3.3
• satisfied RP - 96.8 TO 86.7
• At 3 month postop patients with UCPlt42 cm H2O 5
  times more likely to fail TO vs. RP procedure
• Failure defined SUI present on urodynamics 3
  months postop²

• deTayrac R et al. Prospective randomized trial
  comparing TVT vs. TOT for surgical treatment of
  stress urinary incontinence. Am L Obstet Gynecol.
  2004 190 602-608
• Miller JJ et al., Is obturator tape as effective
  as TVT in patients with borderline maximum
  urethral closure pressure? Am J Obstet Gynecol,
  2006 195(6) 1799-1804.

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Stress Urinary IncontinenceAdvances of Surgical
Management
RP vs. OT SLINGS COMPLICATIONS (META-ANALYSIS)
Bladder injuries Pelvic hematoma Groin
pain (resolves 2 months postop)

• RP SLINGS
• 3.5
• 1.6
• 1.5

TO SLINGS 0.2 0.08 16

• SungVW et al., Am J Obstet Gynecol2007 197 3-11
• Latthe PM et al., BJOG 2007 114 (5)522-531
• Novara G et al., Eur Urol.200853(2) 288-308

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PREFYX PPS SYSTEM
Stress Urinary IncontinenceAdvances of Surgical
Management
The Prefyx PPS Pre-pubic System is designed to
improve safety, efficacy and procedure time.
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PREFYX PPS SYSTEM
Stress Urinary IncontinenceAdvances of Surgical
Management

• Placement of the sling that is outside the pelvic
  bowl potentially
• reduces the incidence of organ and vascular
  injury.

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Stress Urinary IncontinenceAdvances of Surgical
Management
NEEDLELESS SLINGS
TVT Secure Mini-Arc
Needleless
Ethicon
AMS Neomedic
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REMEEX TRT System
Stress Urinary IncontinenceAdvances of Surgical
Management
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REMEEX TRT System
Stress Urinary IncontinenceAdvances of Surgical
Management