Sep \8958 Appell Dmochowski.ppt LMF 1

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1 Surgical Outcomes (How did we get ourselves into this mess?) Roger R. Dmochowski, MD, FACS Department of Urologic Surgery Vanderbilt University School of Medicine Nashville, Tennessee Considerations Evaluation Is there an absolute minimum? Outcomes What s important and for whom? Technologic Advancements Have we reached the apogee of evolution? Evaluation (Fiction) Minimalism is best Rapid Cost effective Accurate Symptoms are predictive of physiologic state Approach acceptable for all comers LMF 1

2 Evaluation (Reality) Special patients special circumstances Tailored assessment Symptoms predictive of underlying cause in 50% When pure SUI exists, minimal evaluation acceptable Mixed UI incidence ( 40 80%) Evaluation (Reality) Role of urodynamics P/ Q outcome data (NYU, Baylor, Vandy) (Predictive of obstructive outcomes) Special populations (Abrams, Herschorn) (Elderly) Detrusor dysfunction adverse impact Predictable only with significant urge Outcomes (Fiction) Success easily reported MD perception Cure is a universal term Unitary aspect sufficient (Are you better?) Efficacy is best measure of benefit Outcomes (Fact) TVT (%) Colposuspension (%) UDS hour pad test Objective cure Negative UDS + pad test Subjective cure No stress leakage No leakage at all Response to procedure Satisfied Recommend LMF 2

3 Outcomes (Reality) Patient is ultimate arbiter MD perception is a secondary (?) concern Result of any intervention is blended reality Subjective + Objective Single item appraisal of intervention (Wein) Complications counterpoise any positive value of intervention (Vandy) Outcomes (Reality) What does the patient want? (Brubaker, Cardoza) Individualized assessment Some would just like improvement Resolution of most significant symptom (which may not be incontinence) Impact on informed consent decision making Technology (Fiction) Better technology provides improved results (provisional factoid) Differing technologies yield similar results (simply unknown) The sphincteric mechanism is mid-urethral (partial factoid) Any specific technology is universally applicable Technology (Fact) Rapid progression in variety of avenues Most active areas Minimally invasive surgery Bulking Oral pharmacotherapy More options -? Better patient satisfaction Dependant on patient education LMF 3

4 Technology ( Fact driven choices) Mid-urethral slings Bladder neck slings Suspensions? Bulking Agents Nylon Tape IVS Technology: Biologic Slings Reality For primary patients all similar performance Sparc Tape TVT Material fate does impact success and is unpredictable for the individual Length important Inter-arcuate distance must be spanned Suspension important (for 4 6 weeks) Suspension technique - probably less important LMF 4

5 Sep \8958 Appell Dmochowski.ppt FDA Adverse Event Reporting (MAUD) (August) Technology: Mid-Urethral Slings (Reality) Probably no system superior to any other Bladder Erosion 35 Urethral Erosion 36 Vaginal Erosion 100 Bowel Perforation 42 Vascular Perforation 15 Pain 19 Material type Death 7 Insertion technique Head to head studies inconclusive (Sand) Vagaries of technique impute efficacy differences LMF Complications contingent on: 5

6 What is a reasonable prediction Technology will continue to progress Techniques will change (Some will come some will go) Don t ask her if she s dry, ask her how much better she is Materials science will evolve Herb Seybold circa 1982 Continued emphasis on outpatient setting will impact evolution PURPOSE AUA STRESS URINARY INCONTINENCE GUIDELINE UPDATE To establish a guideline for the treatment of stress urinary incontinence in two types of index patients. 2005, American Urological Association Education & Research Inc. LMF 6

7 INDEX PATIENTS METHODS The otherwise healthy woman who has decided to seek surgical therapy for stress urinary incontinence (this was only index patient used in first guideline published in 1997 in J Urol) The otherwise healthy woman, who has decided to seek surgical therapy for stress urinary incontinence, and who also has concomitant pelvic organ prolapse , , Literature search results Chosen for Extraction Articles accepted Complications data only Articles rejected SLING PROCEDURES CONSIDERED Autologous fascia with bone anchors Autologous fascia without bone anchors Autologous vaginal wall slings w/without bone anchors Autologous vaginal wall slings with bone anchors Cadaveric with bone anchors Cadaveric without bone anchors Cooper's ligament sling (all sling materials) Homologous tissue (dermis) with bone anchors Homologous tissue (dermis) without bone anchors Synthetic at bladder neck with bone anchors Synthetic at bladder neck without bone anchors Synthetic at midurethra Xenograft with bone anchors Xenograft without bone anchors OTHER PROCEDURES CONSIDERED Suspensions Injectibles Collagen Burch Laparoscopic Open Retropubic Artificial Sphincter LMF 7

8 EFFICACY DATA MONTHS MONTHS > 48 MONTHS INITIAL DATA OBSERVATIONS Burch Laparoscopic Open Retropubic Suspensions MMK Autologous fascia with bone anchors - Suprapubic Autologous fascia without bone anchors Autologous vaginal wall slings with bone anchors Cadaveric without bone anchors Synthetic at bladder neck without bone anchors Synthetic at midurethra Collagen Artificial Sphincter Cure/Dry - No Prolapse RX - Any Evaluation: Months Median Probability & 95% CI RECOMMENDATIONS > 48 MONTHS: Inadequate data to make statement; for example, we know that > 1 million MUS done, but literature has data on only 80 patients MONTHS: Reaffirms data from 1997 Guidelines that Burch = Sling One RCT (Ward, Hilton) Current: BNS = MUS COMPLICATIONS DATA Reporting complications 5% for Autologous and Cadaveric Slings Acute Bleeding Infection Wound UTI / Autologous Erosion Extrusion / Vaginal UTI / Cadaveric Voiding Dysfunction / Cadaveric Erosion Extrusion / Unknown Voiding Dysfunction / Autologous Osteomyelitis LMF 8

9 COMPLICATIONS DATA Reporting Erosion Extrusion / Vaginal Complications for Synthetic Slings at Bladder Neck COMPLICATIONS DATA Reporting complications 5% for MUS Procedures With bone anchors With bone anchor Transvaginal Without bone anchors Conversion Erosion Extrusion/Vaginal Febrile Urethral Injury OBSERVATIONS OBSERVATIONS SLINGS AT BLADDER NECK: Higher rate of retention > 4 weeks post op or requiring surgery than slings at mid-urethra or suspensions DE NOVO URGE POST-OP: Burch & MUS Similar (confidency intervals overlap) UNSPECIFIED URGENCY: Meaning urgency alone or with urge inc, the data does not allow us to distinguish between procedures LMF 9

10 OBSERVATIONS MIXED INCONTINENCE: A small # of studies suggest that McGuire was correct that surgical repair of the SUI component cures the urge component in (~ 70%) of cases OBSERVATIONS BURCH 0% DEATH MUS DEATH NOT REPORTED BUT WE KNOW IT HAPPENS MAUD DATA BASE HAS DEATHS REPORTED EROSION/EXTRUSION/SURGICAL CORRECTION risk important to any subsequent surgical endeavor OBSERVATIONS SECONDARY PROCEDURES: 1) Retreatment rates are not accurate a) Many authors left this out b) Denominators not realistic or known c) Incidence of complications/type of secondary procedure not clear 2) Prolapse rates following SUI procedure TOO VARIABLE TO EVALUATE AREAS FOR FUTURE RESEARCH Prospective randomized controlled trials. Consistency of diagnostic criteria. Standardized outcome measures. Follow up > 12 months. LMF 10

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