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Wich sling for wich patient?

Wich sling for wich patient?. Prof. Paulo Palma UNICAMP, SP, Brazil. Pessaries. HIPOCRATES 375 A C Minimally invasive. “The gold standard”. AUA STRESS INCONTINENCE GUIDELINE COMMITTEE: META-ANALYSIS OF THE LITERATURE: SLINGS ARE MORE DURABLE AND HAVE A HIGHER SUCCES RATE

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Wich sling for wich patient?

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

  2. Pessaries HIPOCRATES 375 A C Minimally invasive

  3. “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

  4. 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

  5. Evidence based analysis“quality of life” • Quality of life: SF – 36 • Bristol • King’s College • SEAPI • others

  6. Evidence based analysis“tolerability - complications” • 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?

  7. Evidence based analysis“comparisons of operations” • 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?

  8. 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 ?

  9. SUBURETHRAL SLINGS • +/- complete, partial or patch • +/- penetration of urogenital diaphram • +/- objectifying appropriate tension • +/- autologous / bio-graft / artificial • +/- bladder neck or mid-urethral

  10. A BRIEF HISTORY OF TIME • 1907 Von Giordano • 1978 McGuire & Lytton Combined Approach • 1993 Petros IVS/TVT • 2001 Delorme TOT • 2002 PalmaReadjustment (bi-directional) SAFYRE t • 2003 Marques-Queimadelos Unidirectional Readjustment- Remeex

  11. A BRIEF HISTORY OF TIMEFIRST PARADIGM SHIFT • 1978: autologous pubovaginal sling * • Aponeurotic free graft • Combines approach 3. Tension-free 4. ISC *1978 McGuire & Lytton

  12. Rationale Bladder Pubis Pubourethral Ligament

  13. uretropelvic Ligament Sacrum A BRIEF HISTORY OF TIMESECOND PARADIGM SHIFT Petros & Ulmsten Uterus P Bladder Utero-sacral Ligament Vag. pubourethral Ligament Tendinous Arc

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

  15. Transobturator Sling urethropelvic ligament pubourethral ligament Pubovaginal Sling RATIONALE

  16. What is the ideal sling? Non adjustables • Autologous • Minimally invasive

  17. Non Adjustable Autologous Efficacy Graft Hospital stay Complications

  18. Non Adjustable Obstruction • 436 slings • 20 urethrolysis • Autologous: 18/210 8.5% • Adjustable synthetic: 2/226 0.8% Autologous: more obstructive Urethrolysis instead of adjustment Palma et al. Eur Urol (A) 2005

  19. A Randomised Trial of Colposuspension 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

  20. 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

  21. TVT Most Serious Reported Complications* (based on over 200,000 patients treated world-wide) Complication US Ex-US Total Vascular Injury 3 25 28 Vaginal Mesh Exposure 19 2 21 Urethral Erosion 12 0 12 Bowel Perforation 8 6 14 Nerve Injury 1 0 1 * As of April 15, 2002, 5 deaths have been reported to GYNECARE that are associated with TVT..

  22. 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.

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

  24. Anterior Abdominal Wall Pubic Symphysis TVT Needle Bowel

  25. 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.

  26. 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.

  27. Non Adjustable TOT • Ozel B et. al.Treatment of voiding dysfunction after transobturator tape procedure. • 2 patients (PO 17 / PO 18) • Successful loosening of the mesh Urology 2004, 64(5):1030.

  28. What is the ideal sling?

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

  30. Adjustable slings 2.Reemex • Safyre

  31. SAFYRE Features • Hybrid & versatile • Universal approach

  32. SAFYRE Features • Re-adjustability • Hybrid & versatile • Universal approach

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

  34. TRANSVAGINAL x TRANSOBTURATOR Palma & Netto, Illustrated Urogynecology , 2005

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

  36. SAFYRE T versus SAFYRE VS RESULTS Cure (p>0,05) VS: 92,1% T : 94 % Improvement (p>0,05) VS: 2,4% T : 2% Palma et al. Int Urogynecol J. 2005

  37. SAFYRE T versus SAFYRE VS RESULTS Mean operative time (p<0,05) VS: 25 min T : 15 min Transient Voiding symptoms (p<0,05) VS: 20.6 % T : 10 % Student’s t test Palma et al. Int Urogynecol J. 2005

  38. SAFYRE T versus SAFYRE VS COMPLICATIONS Bladder injury (p<0,05%) VS: 12 (10%) T : 0 Mesh infection (p>0,05) VS: 4 (3,1%) T : 1 (1%) Palma et al. Int Urogynecol J. 2005

  39. SAFYRE T versus SAFYRE VS • 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

  40. Are all the patients the same? Intrinsic Sphincter Deficiency Pure ISD Hypermobility Good Mild Bad

  41. Perspective: Crossover TOT

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

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

  44. Thank you

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