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Wich sling for wich patient?
Prof. Paulo Palma
UNICAMP, SP, Brazil
HIPOCRATES 375 A CHIPOCRATES 375 A C
Minimally invasiveMinimally invasive
PessariesPessaries
““The gold standard”The gold standard”
AUA STRESS INCONTINENCE GUIDELINE COMMITTEE:
META-ANALYSIS OF THE LITERATURE:
SLINGS ARE MORE DURABLE AND HAVE A HIGHER SUCCES RATEBUT A HIGHER INCIDENCE OF VOIDING DYSFUNCTION
Evidence based analysisEvidence based analysis“efficacy”“efficacy”
• interview / questionnaire / chart / examination / UDS
• accuracy and reliability of the survey instrument
• accuracy and reliability (bias) of patient or interviewer
• “moment in time” : info obtained vs. published
• follow-up: time (minimum / average / range) & dropouts
•
• Quality of life: SF – 36• Bristol• King’s College• SEAPI• others
Evidence based analysis“quality of life”
• what is the complication rate?• is the symptom persistent, exacerbated, or new?• how bothersome to the patient? will it resolve?• if not, what is the nature of the corrective treatment?• if it is medicine: will it be chronic?• if it is surgery, how difficult for the patient?
Evidence based analysisEvidence based analysis“tolerability - complications”“tolerability - complications”
• what is the “gold standard” / does it exist?• is the old or new technique reproducible?• how is one operation compared to another?• retrospective vs prospective? randomized?• who is doing the procedure? individual or group?• is there a learning curve? • are the complications similar?
Evidence based analysis“comparisons of operations”
Evidence Based AnalysisEvidence Based Analysis
• Follow-up “drop-outs” “exclusions” “intent to tx”
• Patients lost to follow-up may have > complication rate•• Complaints that are omitted because of insufficient data
• Patients who refuse surgery may bias outcome
• How does the patient know the alternative treatment ?
SUBURETHRAL SLINGSSUBURETHRAL SLINGS
• +/- complete, partial or patch
• +/- penetration of urogenital diaphram
• +/- objectifying appropriate tension
• +/- autologous / bio-graft / artificial
• +/- bladder neck or mid-urethral
• 1907 Von Giordano• 1978 McGuire & Lytton Combined Approach• 1993 Petros
IVS/TVT• 2001 Delorme TOT • 2002 Palma Readjustment (bi-directional) SAFYRE t • 2003 Marques-Queimadelos Unidirectional
Readjustment - Remeex
A BRIEF HISTORY OF TIME
A BRIEF HISTORY OF TIMEFIRST PARADIGM SHIFT
• 1978: autologous pubovaginal sling *
1. Aponeurotic free graft
2. Combines approach
3. Tension-free
4. ISC
*1978 McGuire & Lytton
PubourethralPubourethralLigamentLigament
PubiPubiss
BladderBladder
RationaleRationale
Utero-sacral Utero-sacral LigamentLigament
BladderBladder
UterusUterus
PP
Tendinous ArcTendinous Arc
pubourethral pubourethral LigamentLigament
SacrumSacrum
Vag.Vag.
A BRIEF HISTORY OF TIMESECOND PARADIGM SHIFTPetros
&Ulmste
n
uretropelvicuretropelvicLigamentLigament
A BRIEF HISTORY OF TIMETOT:THIRD PARADIGM SHIFT A BRIEF HISTORY OF TIMETOT:THIRD PARADIGM SHIFT
Emmanuel Delorme 2001Emmanuel Delorme 2001
Cystoscopy not mandatory
Avoids Retzius space
Less irritative symptoms
Less visceral and vascular
trauma
RATIONALERATIONALE
pubourethral pubourethral ligamentligament
urethropelvicurethropelvicligamentligament
Transobturator SlingTransobturator Sling
Pubovaginal SlingPubovaginal Sling
92
55 54 53
42
0
10
20
30
40
50
60
70
80
90
100
Cirurgias Eletivas Mais RealizadasQuadro Geral Jan-Jun 2003
HC-UNICAMP
Colecistectomia
Sling
Marcapasso
Revasc.MiocárdioMamoplastia
U N ICA M PU N ICA M P
55
2117 17 17
0
10
20
30
40
50
60
Cirurgias Urológicas Eletivas mais realizadas Janeiro a Julho/03
HC-UNICAMP
Sling
RTU Próstata
Prostatectomiaradical
Varicocelectomia
RTU Bexiga
U N ICA M PU N ICA M P
What is the ideal sling?What is the ideal sling?
Non adjustablesNon adjustables
• AutologousAutologous• AutologousAutologous
• Minimally invasiveMinimally invasive• Minimally invasiveMinimally invasive
Non AdjustableNon Adjustable
AutologousAutologous
EfficacyEfficacy
GraftGraft
Hospital stayHospital stay
ComplicationsComplications
Non AdjustableNon Adjustable
ObstructionObstruction• 436 slings• 20 urethrolysis
• Autologous: 18/210 8.5%
• Adjustable synthetic: 2/226 0.8%
Autologous: more obstructiveAutologous: more obstructive
Urethrolysis instead of adjustmentUrethrolysis instead of adjustment
Autologous: more obstructiveAutologous: more obstructive
Urethrolysis instead of adjustmentUrethrolysis instead of adjustment
Palma et al. Eur Urol (A) 2005
A Randomised Trial of A Randomised Trial of Colposuspension and TVTColposuspension and TVT
• Prospective randomized 14 center study• 344 patients 15 month period, ending Aug. 1999
• Methodology - meas. questionnaire; freq. / vol. chart, filling / voiding cystometry, urethral pressure profilometry, ICS 1hr. Pad test, SF-36, EuroQol, Bristol FLUTS questionnaire.
• Measures - Pre-Op, 6 mo., 12 months, 24 month
• Evaluable Patients at 24 mo. - 137 TVT vs. 108 Burch
Karen Ward - Paul Hilton
A Randomised Trial of A Randomised Trial of Colposuspension and TVT Colposuspension and TVT
• Cure rates and quality of life changes
• TVT remained comparable with colposuspension at 24 months
• Economic considerations Surgery details show TVT to be less expensive
due to shorter time and duration of treatment anesthetic room, OR time, recovery room, hospital stay, and hemoglobin during the operation
TVTTVT
Complication US Ex-US TotalVascular Injury 3 25 28Vaginal Mesh Exposure 19 2 21 Urethral Erosion 12 0 12Bowel Perforation 8 6 14Nerve Injury 1 0 1
* As of April 15, 2002, 5 deaths have been reported to GYNECARE that are associated with TVT..
Most Serious Reported Complications* (based on over 200,000 patients treated world-wide)
The Relationship of TVT Insertion to the Vascular Anatomy of the Retropubic Space and the Anterior Abdominal Wall
• Study performed on 10 fresh cadavers • Measured distance from the needle to vessel• • Results: All vessels were lateral to the needle
• Conclusion: “If the TVT needle is laterally directed or externally rotated in the course of insertion, major vascular injury may result”
T.W. Muir, , et al. Paper presentation, 22nd Annual Meeting, AUGS, Oct. 2001.
PubocervicalFascia
TVT Needle
External IliacVein
AccessoryObturatorVein
ObturatorNerve
Pubic Ramus
Pubic Symphysis
TVT Needle
Bowel
Anterior Abdominal Wall
TVTTVT
Rezapour, Ulmsten U. Tension-Free vaginal tape (TVT) in stress incontinent women with intrinsic sphincter deficiency (ISD)-a long-term follow-up.
• 49 patients (3- 5 years F/U)
... ... oldeolderr patients (>70 years) with a very patients (>70 years) with a very low low resting resting urethral pressure and an urethral pressure and an immobileimmobile urethra seem to urethra seem to constitute a risk group where TVT surgery is less constitute a risk group where TVT surgery is less successful...successful...
Int Urogynecol J. 2001, 12 Suppl 2:S12-14.
TVTTVT
Neuman M. Trans vaginal tape readjustment after unsuccessful tension-free vaginal tape (TVT) operation.
• 334 patients• 4 adjustaments • Cure: 3• Failure: 1
There are no reports with others TVT- like slings There are no reports with others TVT- like slings
Neurourol Urodyn 2004;23(3):282-3.
Non Adjustable TOTNon Adjustable TOT
Ozel B Ozel B et. al.et. al. Treatment of Treatment of
voiding dysfunction after voiding dysfunction after
transobturator tape transobturator tape
procedure.procedure.
Urology 2004, 64(5):1030.
• 2 patients (PO 17 / PO 18)• Successful loosening of the mesh
What is the ideal sling?What is the ideal sling?
Adjustable sling: rationaleAdjustable sling: rationale
1. There is a 10-15% failure rate2. Complicated subset of patients
ISDDetrusor hypocontractibilityOrthotopic neobladderObesityChronic pulmonary diseasesOthers
Adjustable slingsAdjustable slings
2.Reemex2.Reemex1.1. SafyreSafyre
SAFYRESAFYRE
FeaturesFeatures
• Hybrid & versatileHybrid & versatile
• Universal approachUniversal approach
SAFYRESAFYRE
• Re-adjustabilityFeaturesFeatures
• Hybrid & versatileHybrid & versatile
• Universal approachUniversal approach
Adjustable slingAdjustable sling
The Ibero-American experience with a re-adjustable minimally invasive sling.
• 126 patients126 patients
• PVR > 100 mlPVR > 100 ml 4 patients (3%) 4 patients (3%)
• 4 successful4 successful readjustments readjustments
Palma et al. BJU Int 2005, 95:341-5.
Palma & Netto, Illustrated Urogynecology , 2005
TRANSVAGINAL x TRANSOBTURATOR
• 226 patients226 patients• 226 patients226 patients
126 vs (mean age 63)126 vs (mean age 63)
F/U 18 monthsF/U 18 months
75 (59%) previous surgery75 (59%) previous surgery
100 t (mean age 61)100 t (mean age 61)
F/U 14 monthsF/U 14 months
65 (65%) previous surgery65 (65%) previous surgery
SAFYRE T versus SAFYRE VSSAFYRE T versus SAFYRE VS
Palma et al. Int Urogynecol J. 2005
SAFYRE T versus SAFYRE VSSAFYRE T versus SAFYRE VS
Cure (p>0,05)Cure (p>0,05)
VS: 92,1%VS: 92,1%
T : 94 %T : 94 %
Improvement (p>0,05)Improvement (p>0,05)
VS: 2,4%VS: 2,4%
T : 2%T : 2%
Palma et al. Int Urogynecol J. 2005
RESULTSRESULTSRESULTSRESULTS
Student’s t testStudent’s t test
Mean operative time (p<0,05)Mean operative time (p<0,05)
VS: 25 minVS: 25 min
T : 15 minT : 15 min
Transient Voiding symptoms Transient Voiding symptoms (p<0,05)(p<0,05)
VS: 20.6 %VS: 20.6 %T : 10 %T : 10 %
Palma et al. Int Urogynecol J. 2005
SAFYRE T versus SAFYRE VSSAFYRE T versus SAFYRE VS
RESULTSRESULTSRESULTSRESULTS
Mesh infection (p>0,05)VS: 4 (3,1%)T : 1 (1%)
Mesh infection (p>0,05)VS: 4 (3,1%)T : 1 (1%)
Bladder injury (p<0,05%)Bladder injury (p<0,05%)
VS: 12 (10%)VS: 12 (10%)
T : 0T : 0
Palma et al. Int Urogynecol J. 2005
SAFYRE T versus SAFYRE VSSAFYRE T versus SAFYRE VS
COMPLICATIONSCOMPLICATIONSCOMPLICATIONSCOMPLICATIONS
• SAFYRE T IS AS EFFECTIVE AS SAFYRE VS
• SAFYRE T LESS OPERATIVE TIME
• SAFYRE T NO VASCULAR OR VISCERAL
TRAUMA
• READJUSTABILITY IMPROVES OUTCOME
Palma et al. Int Urogynecol J. 2005
SAFYRE T versus SAFYRE VSSAFYRE T versus SAFYRE VS
HypermobilityHypermobility
Intrinsic Sphincter
Deficiency
Intrinsic Sphincter
Deficiency
PurePure
Are all the patients the same?
Good Mild Bad
ISDISD
Perspective: Crossover TOTPerspective: Crossover TOT
WHAT WHAT SHOULDSHOULD BE EVALUATED ? BE EVALUATED ?
MAJORMAJOR MINORMINOR
EfficacyEfficacy
SafetySafety CostsCosts
EBMEBM
AdjustAdjust
OutpatientOutpatient
Op timeOp time
Sick leaveSick leave
LearningLearning
ComplicationsComplications
New devicesNew devices
Where the past meets the presentWhere the past meets the present Where the past meets the presentWhere the past meets the present
SoranusSoranus
Primum non nocerePrimum non nocereMinimally invasive Maximally effective
Thank you