Wich sling for wich patient? Prof. Paulo Palma UNICAMP, SP, Brazil

HIPOCRATES 375 A C Minimally invasive Pessaries

“The gold standard” AUA STRESS INCONTINENCE GUIDELINE COMMITTEE: META-ANALYSIS OF THE LITERATURE: SLINGS ARE MORE DURABLE AND HAVE A HIGHER SUCCES RATE BUT A HIGHER INCIDENCE OF VOIDING DYSFUNCTION

Evidence based analysis “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 analysis “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 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 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 TIME FIRST PARADIGM SHIFT 1978: autologous pubovaginal sling * 1.Aponeurotic free graft 2.Combines approach 3. Tension-free 4. ISC *1978 McGuire & Lytton

PubourethralLigament Pubis Bladder Rationale

Utero-sacralLigament Bladder Uterus P Tendinous Arc pubourethralLigament Sacrum Vag. A BRIEF HISTORY OF TIME SECOND PARADIGM SHIFT Petros & Ulmsten uretropelvicLigament

A BRIEF HISTORY OF TIME TOT:THIRD PARADIGM SHIFT Emmanuel Delorme 2001 Cystoscopy not mandatory Avoids Retzius space Less irritative symptoms Less visceral and vascular trauma

RATIONALE pubourethral ligament urethropelvicligament Transobturator Sling Pubovaginal Sling

What is the ideal sling? Non adjustables Autologous Autologous Minimally invasive Minimally invasive

Non Adjustable Autologous Efficacy Graft Hospital stay Complications

Non Adjustable Obstruction 436 slings 20 urethrolysis Autologous: 18/ % Adjustable synthetic: 2/ % Autologous: more obstructive Urethrolysis instead of adjustment Autologous: more obstructive Urethrolysis instead of adjustment Palma et al. Eur Urol (A) 2005

A Randomised Trial of Colposuspension and TVT Prospective randomized 14 center study 344 patients 15 month period, ending Aug 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 TVT vs. 108 Burch Karen Ward - Paul Hilton

A Randomised Trial of 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

TVT ComplicationUSEx-US Total Vascular Injury Vaginal Mesh Exposure Urethral Erosion Bowel Perforation Nerve Injury * 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, 22 nd Annual Meeting, AUGS, Oct

Pubocervical Fascia TVT Needle External Iliac Vein Accessory Obturator Vein Obturator Nerve Pubic Ramus

Pubic Symphysis TVT Needle Bowel Anterior Abdominal Wall

TVT 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)... older patients (>70 years) with a very low resting urethral pressure and an immobile urethra seem to constitute a risk group where TVT surgery is less successful... Int Urogynecol J. 2001, 12 Suppl 2:S12-14.

TVT 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 Neurourol Urodyn 2004;23(3):282-3.

Non Adjustable TOT Ozel B et. al. Treatment of voiding dysfunction after transobturator tape procedure. Urology 2004, 64(5): patients (PO 17 / PO 18) Successful loosening of the mesh

What is the ideal sling?

Adjustable sling: rationale 1.There is a 10-15% failure rate 2.Complicated subset of patients ISD Detrusor hypocontractibility Orthotopic neobladder Obesity Chronic pulmonary diseases Others

Adjustable slings 2.Reemex 1.Safyre

SAFYRE Features Hybrid & versatileHybrid & versatile Universal approachUniversal approach

SAFYRE Re-adjustability Features Hybrid & versatileHybrid & versatile Universal approachUniversal approach

Adjustable sling The Ibero-American experience with a re- adjustable minimally invasive sling. 126 patients 126 patients PVR > 100 ml PVR > 100 ml 4 patients (3%) 4 patients (3%) 4 successful 4 successful readjustments readjustments Palma et al. BJU Int 2005, 95:341-5.

Palma & Netto, Illustrated Urogynecology, 2005 TRANSVAGINAL x TRANSOBTURATOR

226 patients226 patients 126 vs (mean age 63) 126 vs (mean age 63) F/U 18 months F/U 18 months 75 (59%) previous surgery 75 (59%) previous surgery 100 t (mean age 61) 100 t (mean age 61) F/U 14 months F/U 14 months 65 (65%) previous surgery 65 (65%) previous surgery SAFYRE T versus SAFYRE VS Palma et al. Int Urogynecol J. 2005

SAFYRE T versus SAFYRE VS Cure (p>0,05) VS: 92,1% T : 94 % Improvement (p>0,05) VS: 2,4% T : 2% Palma et al. Int Urogynecol J RESULTSRESULTS

Student’s t test Mean operative time (p<0,05) VS: 25 min T : 15 min Transient Voiding symptoms (p<0,05) VS: 20.6 % T : 10 % Palma et al. Int Urogynecol J SAFYRE T versus SAFYRE VS RESULTSRESULTS

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%) VS: 12 (10%) T : 0 Palma et al. Int Urogynecol J SAFYRE T versus SAFYRE VS COMPLICATIONSCOMPLICATIONS

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 SAFYRE T versus SAFYRE VS

Hypermobility Intrinsic Sphincter Deficiency Pure Are all the patients the same? Good MildBad ISD

Perspective: Crossover TOT

WHAT SHOULD BE EVALUATED ? MAJOR MINOR Efficacy Safety Costs EBM Adjust Outpatient Op time Sick leave Learning Complications New devices

Where the past meets the present Where the past meets the present Soranus Primum non nocere Minimally invasive Maximally effective

Thank you