Transcript Stress Urinary Incontinence: Center for Advanced Gynecologic Surgery Advances of Surgical Management

Stress Urinary Incontinence:
Advances of Surgical Management
Eugene Kaplan, MD
Center for Advanced Gynecologic Surgery
and Pelvic Floor Medicine
Stress Urinary Incontinence:
Advances of Surgical Management
AN INCONTINENT MOMENT…
OR
…A LITTLE DRY HUMOR AMONG FRIENDS
Stress Urinary Incontinence:
Advances of Surgical Management
SUI - Is the Most Common Type of UI in Women
Mixed
29%
Urge
22%
Hampel C, et al. Urology. 1997;50 (suppl 6A):4-14.
Stress
49%
Stress Urinary Incontinence:
Advances of Surgical Management
US Prevalence of SUI Symptoms
• 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.
Stress Urinary Incontinence:
Advances of Surgical Management
Surgeries for SUI in the United States
• Incontinence1 - 1998
1. Waetjen LE. Ob Gyn. 2003;101(4):671-676.
(Data from national hospital discharge surveys)
135,000 procedures
Stress Urinary Incontinence:
Advances of Surgical Management
Cost Statistics:
• 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
Stress Urinary Incontinence:
Advances of Surgical Management
Cost Statistics:
Cost To Patient
- $1000/year in absorbent products,
laundry, clothes1,2
1. “Read Karen’s 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.
Stress Urinary Incontinence:
Advances 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. 2003;61(1):37-49.
Stress Urinary Incontinence:
Advances 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. 2003;61(1):37-49.
Stress Urinary Incontinence:
Advances 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
Stress Urinary Incontinence:
Advances of Surgical Management
ETIOLOGIC FACTORS FOR SUI:
• 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)
Stress Urinary Incontinence:
Advances of Surgical Management
SIZE DOES MATTER
Stress Urinary Incontinence:
Advances 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)
1. Vikrup L, et al. Obstet Gynecol 1992; 79: 945-9.
2. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Feb;18(2):133-9
Stress Urinary Incontinence:
Advances of Surgical Management
FUNCTIONAL UNIT:
• Connective tissue
• Pelvic muscles
• Nerves
Stress Urinary Incontinence:
Advances of Surgical Management
FUNCTIONAL UNIT:
• Connective tissue
• Pelvic muscles
• Nerves
Stress Urinary Incontinence:
Advances 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
Stress Urinary Incontinence:
Advances 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, 2003;101: 46-53
Stress Urinary Incontinence:
Advances 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
Stress Urinary Incontinence:
Advances of Surgical Management
MAKING A DIAGNOSIS:
Q-tip Test
- Exaggerated, upward angle of >12 degrees at rest and >30 during
Valsalva is considered evidence of urethral hypermobility
Stress Urinary Incontinence:
Advances of Surgical Management
MAKING A DIAGNOSIS:
Cystoscopy
Sphincteric dysfunction
Urethral hypermobility
Most patients with SUI
Staskin DR. Classification of voiding dysfunction. In: Cardozo L, Staskin DR, eds.
Textbook of Female Urology and Urogynaecology. London: Isis Medical Media;2001:84-89.
Stress Urinary Incontinence:
Advances of Surgical Management
MAKING A DIAGNOSIS:
Urodynamic Evaluation
Stress Urinary Incontinence:
Advances of Surgical Management
AIMS OF CORRECTIVE SURGERY:
EVOLUTION
• Compress outlet (Kelly plication)
• Reposition and restore sphincter unit to higher intraabdominal position (Anterior colporrhaphy)
• Restore pressure transmission differential (MMK, Burch
• “Needle” procedures)
• Provide backboard (Sling procedures)
• Coapt outlet at rest - intrinsic sphincter deficiency (Bulking
agents)
Stress Urinary Incontinence:
Advances of Surgical Management
SURGERY FOR SUI:
RATIONALES
• Anterior repair: compress/plicate/reposition/stabilize
• 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
Stress Urinary Incontinence:
Advances of Surgical Management
ANTERIOR COLPORRHAPHY/PLICATION
• 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.
Stress Urinary Incontinence:
Advances of Surgical Management
MARSHALL-MARCHETTI-KRANTZ (MMK) (1949)
1
• AUA (1997) - mean % cure/dry
– 1-2 yr.: 72 (55-85)
– 2-4 yr.: 83 (75-89)
– > 4 yr.: 83 (76-88)
2
• ICI-2
– cure:
– improvement:
– primary:
– secondary:
– complications:
88%
91%
92%
84%
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.
Stress Urinary Incontinence:
Advances of Surgical Management
BURCH PROCEDURE (John Burch -1961)
1
• AUA (1997) - mean % cure/dry
– 1-2 yr: 85 (78-91)
– 2-4 yr: 84 (79-88)
– 4 yr: 83 (75-90)
2
• ICI-2 - 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.
Stress Urinary Incontinence:
Advances of Surgical Management
BURCH PROCEDURE:
COMLICATIONS
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.
Stress Urinary Incontinence:
Advances of Surgical Management
LAPAROSCOPIC BURCH PROCEDURE
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.
1. Abrams P et al. Incontinence. Report of the 2nd International Consultation on Incontinence, Paris, July 1-3, 2001. 2nd Edition, 2002
2. McDougall EM . Laparoscopic management of female urinary incontinence; Urol Clin North Am. 2001 Feb;28(1):145-9, x.
Stress Urinary Incontinence:
Advances of Surgical Management
NEEDLE SUSPENSION PROCEDURES (NSP)
• 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”
Stress Urinary Incontinence:
Advances of Surgical Management
NEEDLE SUSPENSION PROCEDURES (NSP)
• “… initial success rates … are not maintained with time …
risk of failure is higher than with RPS … few, if any,
indications to perform needle suspension procedure”¹
• AUA – cure/dry rates of NSP – at 4 years only 67%²
• “For surgeons who are experienced in sling operations and
can perform them with minimal morbidity, NS offers no
significant advantages”³
1. Abrams P et al. Incontinence. Report of the 2nd International Consultation on Incontinence, Paris, July 1-3, 2001. 2nd
Edition, 2002.
2. 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. 2001;165:1612-1613.
Stress Urinary Incontinence:
Advances of Surgical Management
PUBOVAGINAL SLING:
“CLASSIC”
• 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
Stress Urinary Incontinence:
Advances of Surgical Management
PUBOVAGINAL SLING:
NEW CONCEPTS
• 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. 1978;119:82-84.
2. Rodriguez LV. Curr Urol Rep. 2001;2:399-406.
Stress Urinary Incontinence:
Advances of Surgical Management
PUBOVAGINAL SLING:
• NATURAL
– Rectus fascia: fulllength, patch
– Fascia lata:
autologous, allogenic
– Dermis: porcine,
human
MATERIALS
• SYNTHETIC
– Gore-Tex
– Nylon
– Perlon
– Mersilene
– Silastic
– Dura
– Polyglactin mesh
– Other
– Prolene
Stress Urinary Incontinence:
Advances of Surgical Management
PUBOVAGINAL SLING:
SUCCESS RATES
• 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
1. 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
2. Abrams P et al. Incontinence. Report of the 2nd International Consultation on Incontinence, Paris, July 1-3, 2001. 2nd Edition, 2002
Stress Urinary Incontinence:
Advances of Surgical Management
PUBOVAGINAL SLING:
• Autologous grafts
– Voiding dysfunction:
2%-20%
– Long-term Self-Cath:
1.5%-7.8%
– De novo DI: 3%-23%
COMPLICATIONS
•
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%
• Allogenic cadaver grafts
– No higher erosion rates
– Higher long-term material
failure (> 20%)
Data compiled by ICI (2002), AUA (1997), Chaikin and Blaivas (2001), Jensen and Rufford (2001), Rodriguez et al (2001).
Stress Urinary Incontinence:
Advances of Surgical Management
GYNECARE TVT
Stress Urinary Incontinence:
Advances of Surgical Management
TENSION-FREE VAGINAL TAPE (TVT)
• Introduced 1995-1996 by Ulmsten and Petros
• Knotted, monofilament, Prolene mesh,
>75 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’”
Stress Urinary Incontinence:
Advances of Surgical Management
MID-URETHRAL SLINGS
(Ins, Outs, Ups, Downs)
Stress Urinary Incontinence:
Advances of Surgical Management
TENSION-FREE VAGINAL TAPE (TVT)
• 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).
Stress Urinary Incontinence:
Advances of Surgical Management
TVT COMPLICATIONS
•
•
•
•
•
•
•
•
Retention
Minor voiding difficulty
Bladder perforation
Urinary tract infection (UTI)
Major vessel injury
Obturator nerve injury
Wound infection
Poorly healing vaginal incision
Kuuva and Nilsson (2000), Nationwide assessment (Finland), 1455 patients.
2.3%
7.5%
3.8%
4.1%
0.1%
0.1%
0.8%
0.7%
Stress Urinary Incontinence:
Advances of Surgical Management
TRANSOBTURATOR MID-URETHRAL SLINGS
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
Stress Urinary Incontinence:
Advances of Surgical Management
TRANSOBTURATOR MID-URETHRAL SLINGS
SUCCESS:
-
cured:
improved:
satisfied:
RP - 83.9% ≈ TO – 90%¹
RP - 9.7% ≈ TO – 3.3%
RP - 96.8% ≈ TO – 86.7%
At 3 month postop patients with UCP<42 cm H2O – 5 times more likely
to fail TO vs. RP procedure
Failure defined SUI present on urodynamics 3 months postop²
1. 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
2. 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.
Stress Urinary Incontinence:
Advances of Surgical Management
RP vs. OT SLINGS COMPLICATIONS (META-ANALYSIS)
RP – SLINGS
TO – SLINGS
Bladder injuries
3.5%
0.2%
Pelvic hematoma
1.6%
0.08%
Groin pain
(resolves 2 months
postop)
1.5%
16%
1. SungVW et al., Am J Obstet Gynecol2007; 197: 3-11
2. Latthe PM et al., BJOG 2007; 114 (5):522-531
3. Novara G et al., Eur Urol.2008;53(2): 288-308
Stress Urinary Incontinence:
Advances of Surgical Management
PREFYX PPS™ SYSTEM
The Prefyx PPS Pre-pubic System is designed to improve safety, efficacy
and procedure time.
Stress Urinary Incontinence:
Advances of Surgical Management
PREFYX PPS™ SYSTEM
Placement of the sling that is outside the pelvic bowl potentially
reduces the incidence of organ and vascular injury.
Stress Urinary Incontinence:
Advances of Surgical Management
“NEEDLELESS” SLINGS
TVT – Secure
Ethicon
Mini-Arc
AMS
Needleless
Neomedic
Stress Urinary Incontinence:
Advances of Surgical Management
REMEEX – TRT System
Stress Urinary Incontinence:
Advances of Surgical Management
REMEEX – TRT System