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2139 PELVIC ORGAN PROLAPSE AND PESSARY USE: IS IT A VIABLE LONG TERM TREATMENT OPTION?
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THE JOURNAL OF UROLOGY姞
susceptible female pelvic floor tissues, and suggest that in LOXL1 KO mice, this may occur through a compensatory mechanism involving enhanced production and activity of LOX. Source of Funding: NIH R01 HD059859, AUA Foundation, and Cleveland Clinic
2139 PELVIC ORGAN PROLAPSE AND PESSARY USE: IS IT A VIABLE LONG TERM TREATMENT OPTION? Sophie Ramsay*, Frederick Bouchard, Le Mai Tu, Sherbrooke, Canada INTRODUCTION AND OBJECTIVES: The main objective of this retrospective study is to evaluate whether long-term use of vaginal pessaries is an appropriate conservative treatment for women with pelvic organ prolapses (POP). METHODS: From 1998 to 2010, 429 women with POP had a pessary trial. Vaginal atrophy and constipation were addressed prior to the trial. Patients were encouraged to use topical estrogen and mucolytic cream at home. A follow-up appointment was scheduled at one month where a pessary maintenance regime was chosen. Additional follow-up visits were then scheduled yearly, or before as patient needs. Data collected included specific information concerning pessary use, incidence of vaginal erosions or other associated morbidities, and subjective satisfaction rate. RESULTS: Average age at presentation was 71.1 ⫾ 9.7 years old. 50% of patients had had hysterectomy and 22% had had a prior prolapse surgery. 62% (n ⫽ 258) of women had a successful pessary trial, defined as a one-month use of the pessary with subjective improvement of symptoms and no significant complication. Median duration of pessary use was 35 months (1-136). 96% of women were satisfied or very satisfied with their pessaries. 66% (n ⫽ 170) of patients could handle pessary by self-maintenance, while 23% (n ⫽ 59) needed assistance from a regional nurse, and 11% (n ⫽ 28) necessitated maintenance by our clinic nurses. Pessary self-maintenance regime was associated with a prolonged pessary use (38 months vs 30 months for the nurse group vs 27 months for the clinic group, p ⫽ 0.021). The overall erosion rate was 16%. Multivariate analysis demonstrated that erosions are associated with older age (p ⫽ 0.011), constipation (p ⫽ 0.018), and use of topical estrogen cream (p ⫽ 0.001). The severity of vaginal atrophy increased with older age (p ⬍ 0.001) and older patients were therefore more likely to use topical estrogen cream (p ⬍ 0.001). Both the severity of vaginal atrophy and intensive estrogen treatment before pessary trial were associated with a higher rate of erosions (p ⬍ 0.001 and p ⫽ 0.04). There was no major complication. 66% (n ⫽ 170) of women who underwent a successful pessary trial are still using a pessary. CONCLUSIONS: Vaginal pessaries appear to be an appropriate treatment option for women with troublesome POP. These longterm results show that patient’s satisfaction is excellent and most women who underwent a successful pessary trial continue to use pessary through time. Regular maintenance and follow-up are essential, especially as the occurrence of vaginal erosions is difficult to predict. Erosions do not seem totally preventable by the use of topical estrogen. Source of Funding: None
Vol. 187, No. 4S, Supplement, Wednesday, May 23, 2012
2140 ABDOMINAL COLPOPEXY: COMPARISON OF ENDOSCOPIC SURGICAL STRATEGIES Jennifer Anger*, Los Angeles, CA; Elizabeth Mueller, Maywood, IL; Chris Tarnay, Los Angeles, CA; Linda Brubaker, Maywood, IL; Amy Rosenman, Los Angeles, CA; Bridget Smith, Kevin Stroupe, Maywood, IL; Catherine Bresee, Los Angeles, CA; Kimberly Kenton, Maywood, IL INTRODUCTION AND OBJECTIVES: Laparoscopic (LASC) and robotic (RASC) sacrocolpopexy are widely used for the treatment of pelvic organ prolapse (POP). However, strong evidence comparing outcomes and costs for the procedures is lacking. METHODS: Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS, NCT01124916) is a 2-center randomized comparative effectiveness trial conducted at UCLA/Cedars-Sinai and Loyola University Medical Centers. The primary aim compared costs of RASC and LASC. Following a clinical decision for ASC and research consent, participants with greater than or equal to symptomatic stage II POP including apical support loss to greater than 0.5 TVL were randomized to LASC or RASC on the day of surgery. Concomitant surgeries, including hysterectomy, posterior repair, and midurethral sling were allowed. Costs of care were based on each patient’s billing record and equipment costs at each hospital. All costs associated with surgical procedure including costs for robot, initial hospitalization, and any re-hospitalization in the 1st 6 weeks were compared between groups. Secondary outcomes included postoperative pain, POP quantification, symptom severity and quality of life, and adverse events (AE). Power calculation determined that 32 women in each arm would provide ⬎ 99% power to detect $4800 difference in total charges, using a 2-sided t-test with significance level of 0.05. RESULTS: 78 women with mean age of 59 years (range 26-79) were randomized: LASC (38) and RASC (40). Hospital costs for RASC were higher than for LASC ($20,459 vs $12,022, P⬍0.0001). Over 6 weeks, hospital costs remained higher for RASC ($24,870 vs $13,840, P⫽0.008). Excluding costs of robot, hospital costs of RASC vs LASC ($13,428 vs $12,022, P ⫽ 0.06) and hospital costs over 6 weeks ($17,839 vs $13,840, P⫽0.32) were not significantly different. Total operating room time for RASC was slightly longer (202 vs 179 minutes, P⫽0.03). Women with RASC reported higher pain scores by visual assessment scales 1-week after surgery; however, pain scores did not differ by 2-weeks. There were no differences in complications, symptom bother, or POP stage three months after surgery. CONCLUSIONS: Costs of RASC are higher than LASC, while short-term outcomes and complications are similar. Primary cost differences resulted from robot maintenance and purchase costs. LASC
RASC
Variable Mean UDI (SD)
Baseline 99.0 (60.6)
3 months 25.6 (41.4)
Basline 110.7 (59.4)
3 months 30.3 (42.1)
P value 0.50
POPDI (SD)
116.4 (61.6)
27.5 (27.8)
126.1 (63.9)
32.7 (45.4)
0.65
CRADI (SD)
100.6 (34.3)
34.3 (34.0)
87.9 (71.5)
44.1 (48.3)
0.12
POPQ Point Ba (SD)
2.5 (1.8)
⫺2.4 (1.2)
2.6 (2.0)
⫺2.6 (0.7)
0.74
POPQ Point C (SD)
0.7 (3.6)
⫺7.7 (4.8)
0.2 (4.0)
⫺7.9 (5.1)
0.98
Source of Funding: Funded by a National Institute of Biomedical Imaging and Bioengineering Recovery Act Limited Competition Challenge Grant (1 RC1 EB010649-01)
THE JOURNAL OF UROLOGY姞
susceptible female pelvic floor tissues, and suggest that in LOXL1 KO mice, this may occur through a compensatory mechanism involving enhanced production and activity of LOX. Source of Funding: NIH R01 HD059859, AUA Foundation, and Cleveland Clinic
2139 PELVIC ORGAN PROLAPSE AND PESSARY USE: IS IT A VIABLE LONG TERM TREATMENT OPTION? Sophie Ramsay*, Frederick Bouchard, Le Mai Tu, Sherbrooke, Canada INTRODUCTION AND OBJECTIVES: The main objective of this retrospective study is to evaluate whether long-term use of vaginal pessaries is an appropriate conservative treatment for women with pelvic organ prolapses (POP). METHODS: From 1998 to 2010, 429 women with POP had a pessary trial. Vaginal atrophy and constipation were addressed prior to the trial. Patients were encouraged to use topical estrogen and mucolytic cream at home. A follow-up appointment was scheduled at one month where a pessary maintenance regime was chosen. Additional follow-up visits were then scheduled yearly, or before as patient needs. Data collected included specific information concerning pessary use, incidence of vaginal erosions or other associated morbidities, and subjective satisfaction rate. RESULTS: Average age at presentation was 71.1 ⫾ 9.7 years old. 50% of patients had had hysterectomy and 22% had had a prior prolapse surgery. 62% (n ⫽ 258) of women had a successful pessary trial, defined as a one-month use of the pessary with subjective improvement of symptoms and no significant complication. Median duration of pessary use was 35 months (1-136). 96% of women were satisfied or very satisfied with their pessaries. 66% (n ⫽ 170) of patients could handle pessary by self-maintenance, while 23% (n ⫽ 59) needed assistance from a regional nurse, and 11% (n ⫽ 28) necessitated maintenance by our clinic nurses. Pessary self-maintenance regime was associated with a prolonged pessary use (38 months vs 30 months for the nurse group vs 27 months for the clinic group, p ⫽ 0.021). The overall erosion rate was 16%. Multivariate analysis demonstrated that erosions are associated with older age (p ⫽ 0.011), constipation (p ⫽ 0.018), and use of topical estrogen cream (p ⫽ 0.001). The severity of vaginal atrophy increased with older age (p ⬍ 0.001) and older patients were therefore more likely to use topical estrogen cream (p ⬍ 0.001). Both the severity of vaginal atrophy and intensive estrogen treatment before pessary trial were associated with a higher rate of erosions (p ⬍ 0.001 and p ⫽ 0.04). There was no major complication. 66% (n ⫽ 170) of women who underwent a successful pessary trial are still using a pessary. CONCLUSIONS: Vaginal pessaries appear to be an appropriate treatment option for women with troublesome POP. These longterm results show that patient’s satisfaction is excellent and most women who underwent a successful pessary trial continue to use pessary through time. Regular maintenance and follow-up are essential, especially as the occurrence of vaginal erosions is difficult to predict. Erosions do not seem totally preventable by the use of topical estrogen. Source of Funding: None
Vol. 187, No. 4S, Supplement, Wednesday, May 23, 2012
2140 ABDOMINAL COLPOPEXY: COMPARISON OF ENDOSCOPIC SURGICAL STRATEGIES Jennifer Anger*, Los Angeles, CA; Elizabeth Mueller, Maywood, IL; Chris Tarnay, Los Angeles, CA; Linda Brubaker, Maywood, IL; Amy Rosenman, Los Angeles, CA; Bridget Smith, Kevin Stroupe, Maywood, IL; Catherine Bresee, Los Angeles, CA; Kimberly Kenton, Maywood, IL INTRODUCTION AND OBJECTIVES: Laparoscopic (LASC) and robotic (RASC) sacrocolpopexy are widely used for the treatment of pelvic organ prolapse (POP). However, strong evidence comparing outcomes and costs for the procedures is lacking. METHODS: Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS, NCT01124916) is a 2-center randomized comparative effectiveness trial conducted at UCLA/Cedars-Sinai and Loyola University Medical Centers. The primary aim compared costs of RASC and LASC. Following a clinical decision for ASC and research consent, participants with greater than or equal to symptomatic stage II POP including apical support loss to greater than 0.5 TVL were randomized to LASC or RASC on the day of surgery. Concomitant surgeries, including hysterectomy, posterior repair, and midurethral sling were allowed. Costs of care were based on each patient’s billing record and equipment costs at each hospital. All costs associated with surgical procedure including costs for robot, initial hospitalization, and any re-hospitalization in the 1st 6 weeks were compared between groups. Secondary outcomes included postoperative pain, POP quantification, symptom severity and quality of life, and adverse events (AE). Power calculation determined that 32 women in each arm would provide ⬎ 99% power to detect $4800 difference in total charges, using a 2-sided t-test with significance level of 0.05. RESULTS: 78 women with mean age of 59 years (range 26-79) were randomized: LASC (38) and RASC (40). Hospital costs for RASC were higher than for LASC ($20,459 vs $12,022, P⬍0.0001). Over 6 weeks, hospital costs remained higher for RASC ($24,870 vs $13,840, P⫽0.008). Excluding costs of robot, hospital costs of RASC vs LASC ($13,428 vs $12,022, P ⫽ 0.06) and hospital costs over 6 weeks ($17,839 vs $13,840, P⫽0.32) were not significantly different. Total operating room time for RASC was slightly longer (202 vs 179 minutes, P⫽0.03). Women with RASC reported higher pain scores by visual assessment scales 1-week after surgery; however, pain scores did not differ by 2-weeks. There were no differences in complications, symptom bother, or POP stage three months after surgery. CONCLUSIONS: Costs of RASC are higher than LASC, while short-term outcomes and complications are similar. Primary cost differences resulted from robot maintenance and purchase costs. LASC
RASC
Variable Mean UDI (SD)
Baseline 99.0 (60.6)
3 months 25.6 (41.4)
Basline 110.7 (59.4)
3 months 30.3 (42.1)
P value 0.50
POPDI (SD)
116.4 (61.6)
27.5 (27.8)
126.1 (63.9)
32.7 (45.4)
0.65
CRADI (SD)
100.6 (34.3)
34.3 (34.0)
87.9 (71.5)
44.1 (48.3)
0.12
POPQ Point Ba (SD)
2.5 (1.8)
⫺2.4 (1.2)
2.6 (2.0)
⫺2.6 (0.7)
0.74
POPQ Point C (SD)
0.7 (3.6)
⫺7.7 (4.8)
0.2 (4.0)
⫺7.9 (5.1)
0.98
Source of Funding: Funded by a National Institute of Biomedical Imaging and Bioengineering Recovery Act Limited Competition Challenge Grant (1 RC1 EB010649-01)