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1164 TWENTY-FOUR-MONTH OUTCOMES OF RANDOMIZED EQUIVALENCE TRIAL OF RETROPUBIC AND TRANSOBTURATOR MIDURETHRAL SLINGS (TOMUS)
Vol. 185, No. 4S, Supplement, Monday, May 16, 2011
classification (Stress incontinence (SUI), Emptying, Anatomy (anterior vaginal wall descent), Protection (pad use), Inhibition (urge incontinence)), and quality of life (QoL) questionnaires {SF-IIQ-7, UDI-6, and visual analog scale of global satisfaction (VAS, 1–10)}. Global cure was defined as SEAPI subjective composite ⫽ 0 and VAS ⬎⫽ 8. SUI cure was defined as SEAPI-subjective (S) subset ⫽ 0 and a negative CST. Demographics and perioperative morbidity were abstracted from the hospital and clinic charts. Statistical evaluation was conducted. RESULTS: 106 women completed a minimum follow-up of 36 months (41 BOV, 65 ARF). Due to differences in patient populations between the 2 hospitals, women in the BOV group were older, more parous, and had greater degrees of concomitant prolapse. Preoperative SEAPI scores and QoL indices were not statistically different (NS) between groups. SUI cure rates for BOV and ARF were 80.5% and 73.8%, respectively (NS). Global cure rates for BOV and ARF were 48.8% and 47.7%, respectively (NS). SUI cure rates remained relatively stable with longer follow-up, while global cure rates declined. Perioperative complications, rates of short-term and long-term voiding dysfunction, and rates of reoperation for recurrent SUI or prolapse were similar (NS). For each material, there was a significant postoperative improvement in SEAPI scores and all QoL indices, and improvement was similar between ARF and BOV groups (NS). CONCLUSIONS: At long-term follow-up, BOV continues to be a durable substitute for ARF in a population at high-risk for surgical failure. Global and SUI-specific clinical outcomes are similar to the ARF sling, and rates of complications continue to be low. Source of Funding: None
1164 TWENTY-FOUR-MONTH OUTCOMES OF RANDOMIZED EQUIVALENCE TRIAL OF RETROPUBIC AND TRANSOBTURATOR MIDURETHRAL SLINGS (TOMUS) Michael Albo*, San Diego, CA; Heather Litman, Watertown, MA; Gary Lemack, Dallas, TX; Holly Richter, Birmingham, AL; Toby Chai, Baltimore, MD; Kimberly Kenton, Maywood, IL; Stephen Kraus, San Antonio, TX; Larry Sirls, Royal Oak, MI; Halina Zyczynski, Pittsburgh, PA; Peggy Norton, Salt Lake City, UT; Ann Gormley, Hanover, NH; John Kusek, Bethesda, MD INTRODUCTION AND OBJECTIVES: Transobturator and retropubic midurethral slings (TMUS and RMUS) are common surgical techniques for women with stress urinary incontinence (SUI), but their longer-term comparative efficacy is unknown. We assessed 24-month outcomes in a randomized equivalence trial of TMUS and RMUS. METHODS: Primary outcomes were objective and subjective SUI cure rates at 12 and 24 months after surgery; 12-month outcomes were reported previously. Objective cure was defined as a negative stress test, negative pad test and no retreatment. Subjective cure was defined as no self-reported SUI symptoms, no leakage episodes on 3-day bladder diary and no retreatment. An equivalence margin of ⫹/12% was established a priori. The primary analysis for equivalence was per protocol (assigned surgery performed); all other analyses were intention-to-treat. Secondary outcomes included persistent or de novo urge incontinence; voiding dysfunction and mesh complications; patient satisfaction, and scores on Urinary Distress Inventory (UDI) and Incontinence Impact Questionnaire (IIQ). RESULTS: 516 (88.5%) of 583 randomized participants who received the assigned surgery completed the 24-month assessment. Mean age was 53 ⫹ 11 years. Objective success rates for RMUS and TMUS were 77.3% and 72.3%, respectively (95% CI for difference of 5.1%: -2.0, 12.1%). Subjective success rates were 55.7% and 48.3% (CI for difference of 7.4%: -0.7, 15.5%). The statistical test for equivalence was inconclusive for both objective and subjective success. No differences were noted between the groups with regard to patient satisfaction (RMUS 86.3% vs. TMUS 88.1%, p⫽0.58), change in total UDI scores (RMUS 100 vs. TMUS 107, p ⫽0.13), change in total IIQ scores (RMUS 125 vs. TMUS 124, p⫽0.89), de novo urge incontinence (RMUS 0% vs. TMUS 0.3%, p⫽ 0.99), persistent urge incon-
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tinence (RMUS 14.1% vs. TMUS 12.7%, p⫽0.63) or mesh exposure (RMUS 1.3% vs. TMUS 0.7%, p⫽0.41). Similar to findings at 12 months, the RMUS group had higher rates of voiding dysfunction requiring surgery (3.0% vs. 0%, p⫽0.002) and urinary tract infections (17.1% vs. 10.7%, p⫽0.025), and the TMUS group had a higher rate of neurologic symptoms (4.4% vs. 9.4%, p⫽0.023). CONCLUSIONS: Although objective outcomes of RMUS and TMUS were equivalent at 12 months, 24-month objective and subjective cure rates did not meet predefined criteria for equivalence. Patient satisfaction remained high and symptom severity remained markedly improved compared to baseline for both groups. No additional differences in adverse events were identified. Source of Funding: Supported by cooperative agreements (U01 DK58225, U01 DK58229, U01 DK58234, U01 DK58231, U01 DK60379, U01 DK60380, U01 DK60393, U01 DK60395, U01 DK60397, and U01 DK60401) from the National Institute of Diabetes and Digestive and Kidney Diseases and by the National Institute of Child Health and Human Development.
1165 TWO-YEAR FOLLOW-UP RESULTS IN A MULTI-CENTER, PROSPECTIVE TRIAL OF THE ADVANCE MALE SLING SYSTEM FOR THE TREATMENT OF POST-PROSTATECTOMY STRESS URINARY INCONTINENCE Michael J Kennelly*, Charlotte, NC; Kurt A McCammon, Norfolk, VA; L Dean Knoll, Nashville, TN; LeRoy A Jones, San Antonio, TX; Gregory T Bales, Chicago, IL; Sender Herschorn, Toronto, Canada; Brian Roberts, Myrtle Beach, SC; Timothy B Boone, Houston, TX; George D Webster, Durham, NC INTRODUCTION AND OBJECTIVES: We report on 2-year clinical results from a North American study using the AdVance® transobturator male sling for the treatment of post-prostatectomy incontinence (PPI). METHODS: A multi-center, prospective study was conducted at 10 centers. Men ⱖ40 years of age with PPI of at least 6 months duration were eligible for the IRB approved study. Pad weights (1-hour and 24-hour) and pads used per day were assessed pre-operatively and at follow-up. Improvement in quality of life (QOL) was evaluated by 3 QOL questionnaires. Follow-up occurred at 6 weeks and at 3, 6, 12, and 24 months postoperatively. Complete baseline and follow-up data could not be collected for all patients. Therefore, in addition to comparison of baseline results to 12-and 24-month follow-up results, the data were also analyzed with the last observation carried forward (LOCF) for those with follow-up results, and a worst case scenario (WCS) analysis defined as LOCF including the baseline results being used as the 24-month result. RESULTS: Between February 2006 and April 2007, 49 men with PPI were implanted with the AdVance sling. Mean age was 64.5 years. Results show a highly significant pad weight test improvement for all analyses. In addition, pads per day results showed that ⬃70% of patients used 0 –1 pads per day at 12 and 24-months. QOL scores also showed significant improvement at both 12 and 24-months. There were no instances of long term retention, urethral erosion, or urethral or bladder perforation. Results show that lower pad usage at baseline increased the likelihood of postoperative success. Also, post-hoc analysis of 24-hour pad weight data did show that patients with lower baseline 24-hour pad weights were more likely to use 0 –1 pads per day at 24-month follow-up (p ⫽ 0.005). CONCLUSIONS: This two-year multi-center, prospective study demonstrates the safety and effectiveness of the transobturator sling in the treatment of mild to moderate PPI. Continence rates improved and were maintained through 24-month follow-up. This minimally-invasive sling carries a low incidence of adverse events yet maintains high QOL improvements. Proper patient selection and surgical technique refinement noted during this study will likely further enhance patient outcomes.
classification (Stress incontinence (SUI), Emptying, Anatomy (anterior vaginal wall descent), Protection (pad use), Inhibition (urge incontinence)), and quality of life (QoL) questionnaires {SF-IIQ-7, UDI-6, and visual analog scale of global satisfaction (VAS, 1–10)}. Global cure was defined as SEAPI subjective composite ⫽ 0 and VAS ⬎⫽ 8. SUI cure was defined as SEAPI-subjective (S) subset ⫽ 0 and a negative CST. Demographics and perioperative morbidity were abstracted from the hospital and clinic charts. Statistical evaluation was conducted. RESULTS: 106 women completed a minimum follow-up of 36 months (41 BOV, 65 ARF). Due to differences in patient populations between the 2 hospitals, women in the BOV group were older, more parous, and had greater degrees of concomitant prolapse. Preoperative SEAPI scores and QoL indices were not statistically different (NS) between groups. SUI cure rates for BOV and ARF were 80.5% and 73.8%, respectively (NS). Global cure rates for BOV and ARF were 48.8% and 47.7%, respectively (NS). SUI cure rates remained relatively stable with longer follow-up, while global cure rates declined. Perioperative complications, rates of short-term and long-term voiding dysfunction, and rates of reoperation for recurrent SUI or prolapse were similar (NS). For each material, there was a significant postoperative improvement in SEAPI scores and all QoL indices, and improvement was similar between ARF and BOV groups (NS). CONCLUSIONS: At long-term follow-up, BOV continues to be a durable substitute for ARF in a population at high-risk for surgical failure. Global and SUI-specific clinical outcomes are similar to the ARF sling, and rates of complications continue to be low. Source of Funding: None
1164 TWENTY-FOUR-MONTH OUTCOMES OF RANDOMIZED EQUIVALENCE TRIAL OF RETROPUBIC AND TRANSOBTURATOR MIDURETHRAL SLINGS (TOMUS) Michael Albo*, San Diego, CA; Heather Litman, Watertown, MA; Gary Lemack, Dallas, TX; Holly Richter, Birmingham, AL; Toby Chai, Baltimore, MD; Kimberly Kenton, Maywood, IL; Stephen Kraus, San Antonio, TX; Larry Sirls, Royal Oak, MI; Halina Zyczynski, Pittsburgh, PA; Peggy Norton, Salt Lake City, UT; Ann Gormley, Hanover, NH; John Kusek, Bethesda, MD INTRODUCTION AND OBJECTIVES: Transobturator and retropubic midurethral slings (TMUS and RMUS) are common surgical techniques for women with stress urinary incontinence (SUI), but their longer-term comparative efficacy is unknown. We assessed 24-month outcomes in a randomized equivalence trial of TMUS and RMUS. METHODS: Primary outcomes were objective and subjective SUI cure rates at 12 and 24 months after surgery; 12-month outcomes were reported previously. Objective cure was defined as a negative stress test, negative pad test and no retreatment. Subjective cure was defined as no self-reported SUI symptoms, no leakage episodes on 3-day bladder diary and no retreatment. An equivalence margin of ⫹/12% was established a priori. The primary analysis for equivalence was per protocol (assigned surgery performed); all other analyses were intention-to-treat. Secondary outcomes included persistent or de novo urge incontinence; voiding dysfunction and mesh complications; patient satisfaction, and scores on Urinary Distress Inventory (UDI) and Incontinence Impact Questionnaire (IIQ). RESULTS: 516 (88.5%) of 583 randomized participants who received the assigned surgery completed the 24-month assessment. Mean age was 53 ⫹ 11 years. Objective success rates for RMUS and TMUS were 77.3% and 72.3%, respectively (95% CI for difference of 5.1%: -2.0, 12.1%). Subjective success rates were 55.7% and 48.3% (CI for difference of 7.4%: -0.7, 15.5%). The statistical test for equivalence was inconclusive for both objective and subjective success. No differences were noted between the groups with regard to patient satisfaction (RMUS 86.3% vs. TMUS 88.1%, p⫽0.58), change in total UDI scores (RMUS 100 vs. TMUS 107, p ⫽0.13), change in total IIQ scores (RMUS 125 vs. TMUS 124, p⫽0.89), de novo urge incontinence (RMUS 0% vs. TMUS 0.3%, p⫽ 0.99), persistent urge incon-
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tinence (RMUS 14.1% vs. TMUS 12.7%, p⫽0.63) or mesh exposure (RMUS 1.3% vs. TMUS 0.7%, p⫽0.41). Similar to findings at 12 months, the RMUS group had higher rates of voiding dysfunction requiring surgery (3.0% vs. 0%, p⫽0.002) and urinary tract infections (17.1% vs. 10.7%, p⫽0.025), and the TMUS group had a higher rate of neurologic symptoms (4.4% vs. 9.4%, p⫽0.023). CONCLUSIONS: Although objective outcomes of RMUS and TMUS were equivalent at 12 months, 24-month objective and subjective cure rates did not meet predefined criteria for equivalence. Patient satisfaction remained high and symptom severity remained markedly improved compared to baseline for both groups. No additional differences in adverse events were identified. Source of Funding: Supported by cooperative agreements (U01 DK58225, U01 DK58229, U01 DK58234, U01 DK58231, U01 DK60379, U01 DK60380, U01 DK60393, U01 DK60395, U01 DK60397, and U01 DK60401) from the National Institute of Diabetes and Digestive and Kidney Diseases and by the National Institute of Child Health and Human Development.
1165 TWO-YEAR FOLLOW-UP RESULTS IN A MULTI-CENTER, PROSPECTIVE TRIAL OF THE ADVANCE MALE SLING SYSTEM FOR THE TREATMENT OF POST-PROSTATECTOMY STRESS URINARY INCONTINENCE Michael J Kennelly*, Charlotte, NC; Kurt A McCammon, Norfolk, VA; L Dean Knoll, Nashville, TN; LeRoy A Jones, San Antonio, TX; Gregory T Bales, Chicago, IL; Sender Herschorn, Toronto, Canada; Brian Roberts, Myrtle Beach, SC; Timothy B Boone, Houston, TX; George D Webster, Durham, NC INTRODUCTION AND OBJECTIVES: We report on 2-year clinical results from a North American study using the AdVance® transobturator male sling for the treatment of post-prostatectomy incontinence (PPI). METHODS: A multi-center, prospective study was conducted at 10 centers. Men ⱖ40 years of age with PPI of at least 6 months duration were eligible for the IRB approved study. Pad weights (1-hour and 24-hour) and pads used per day were assessed pre-operatively and at follow-up. Improvement in quality of life (QOL) was evaluated by 3 QOL questionnaires. Follow-up occurred at 6 weeks and at 3, 6, 12, and 24 months postoperatively. Complete baseline and follow-up data could not be collected for all patients. Therefore, in addition to comparison of baseline results to 12-and 24-month follow-up results, the data were also analyzed with the last observation carried forward (LOCF) for those with follow-up results, and a worst case scenario (WCS) analysis defined as LOCF including the baseline results being used as the 24-month result. RESULTS: Between February 2006 and April 2007, 49 men with PPI were implanted with the AdVance sling. Mean age was 64.5 years. Results show a highly significant pad weight test improvement for all analyses. In addition, pads per day results showed that ⬃70% of patients used 0 –1 pads per day at 12 and 24-months. QOL scores also showed significant improvement at both 12 and 24-months. There were no instances of long term retention, urethral erosion, or urethral or bladder perforation. Results show that lower pad usage at baseline increased the likelihood of postoperative success. Also, post-hoc analysis of 24-hour pad weight data did show that patients with lower baseline 24-hour pad weights were more likely to use 0 –1 pads per day at 24-month follow-up (p ⫽ 0.005). CONCLUSIONS: This two-year multi-center, prospective study demonstrates the safety and effectiveness of the transobturator sling in the treatment of mild to moderate PPI. Continence rates improved and were maintained through 24-month follow-up. This minimally-invasive sling carries a low incidence of adverse events yet maintains high QOL improvements. Proper patient selection and surgical technique refinement noted during this study will likely further enhance patient outcomes.