Long-term increase seen in abdominal sacrocolpopexy failure rates

More than 225,000 operations are performed each year in the United States for pelvic organ prolapse (POP). Abdominal sacrocolpopexy is considered the most durable of these procedures, but long-term outcomes need to be studied, say researchers from University of Utah School of Medicine, Salt Lake City.1 Direct costs for these procedures exceed $1 billion per year, and, as the population ages, the need to treat POP and urinary incontinence will rise.1

The original Colpopexy and Urinary Reduction Efforts (CARE) trial included 322 women without stress urinary incontinence (SUI) who underwent abdominal sacrocolpopexy between 2002 and 2005 for symptomatic POP. Because SUI is a common adverse event following POP surgery, study patients were randomly assigned to receive concomitant Burch urethropexy or no urethropexy.

Details of the study
The extended CARE study enrolled 92% (215/233) of eligible 2-year CARE trial completers. A total of 181 (84%) of the 215 women went on to complete 5 years of follow-up, and 126 (56%) completed 7 years of follow-up. The primary goals of the extended CARE study, as reported in JAMA, were to compare long-term anatomic success rates, stress continence rates, overall pelvic floor symptoms, pelvic-floor–specific quality of life (QOL), and mesh-related adverse events.

RESULTS

Treatment failure probability. Treatment failure was considered symptomatic or anatomic POP, SUI, or overall urinary incontinence score of 3 or greater on the Incontinence Severity Index. The procedure’s failure rates showed a gradual increase over the follow-up, in both the urethropexy group and the no urethropexy group.

Urethropexy vs no urethropexy. By year 7, the estimated probabilities of treatment failure for the urethropexy group versus the no urethropexy group, respectively, were:

• for anatomic POP – 0.27 versus 0.22 (treatment difference of 0.05; 95% confidence interval [CI], 0.161 to 0.271)
• for symptomatic POP – 0.29 versus 0.24 (treatment difference of 0.049; 95% CI, 0.060 to 0.162)
• for composite POP – 0.48 versus 0.34 (treatment difference of 0.134; 95% CI, 0.096 to 0.322)
• for SUI – 0.62 versus 0.77 (treatment difference of 0.153; 95% CI, 0.268 to 0.030)
• for overall urinary incontinence – 0.75 versus 0.81 (treatment difference of 0.064; 95% CI, 0.161 to 0.032).

Mesh erosion probability. By year 2, 3 of the 322 women enrolled in CARE had suture erosion and 17 had mesh erosion. There were 2 additional cases of suture erosion and 6 additional cases of mesh erosion by year 7. All types of mesh eroded. The estimated probability of mesh erosion in the CARE and extended CARE trials at the time of the last known treatment failure (6.18 years) was 10.5% (95% CI, 6.8%-16.1%).

Repeat surgery probability. By year 7, at least 36 of 215 women (16.7%) in the extended CARE trial had additional surgery related to pelvic floor disorders, 11 for recurrent POP, 14 for SUI, and 11 for mesh complications.

ABDOMINAL SACROCOLPOPEXY FOR POP IS LESS EFFECTIVE THAN DESIRED

During 7 years of follow-up, abdominal sacrocolpopexy failure rates increased in both the urethropexy group and the no urethropexy group, although urethropexy prevented SUI longer than no urethropexy. “By 5 years, nearly one-third of women met our composite failure definition,” said the authors.¹

“Based on our results,” they write, “women considering abdominal sacrocolpopexy should be counseled that this procedure effectively provides relief from POP symptoms; however, the anatomic support deteriorates over time. Adding an anti-incontinence procedure for women continent preoperatively decreases, but does not eliminate, the risk of de novo SUI. Surgical counseling about the ongoing risk of mesh-related events even for abdominal sacrocolpopexy is critical. Women should be aware that symptoms such as vaginal bleeding, discharge, and pain may be due to mesh erosion and should seek help accordingly.”¹

We want to hear from you! Tell us what you think.

More than 225,000 operations are performed each year in the United States for pelvic organ prolapse (POP). Abdominal sacrocolpopexy is considered the most durable of these procedures, but long-term outcomes need to be studied, say researchers from University of Utah School of Medicine, Salt Lake City.1 Direct costs for these procedures exceed $1 billion per year, and, as the population ages, the need to treat POP and urinary incontinence will rise.1

The original Colpopexy and Urinary Reduction Efforts (CARE) trial included 322 women without stress urinary incontinence (SUI) who underwent abdominal sacrocolpopexy between 2002 and 2005 for symptomatic POP. Because SUI is a common adverse event following POP surgery, study patients were randomly assigned to receive concomitant Burch urethropexy or no urethropexy.

Details of the study
The extended CARE study enrolled 92% (215/233) of eligible 2-year CARE trial completers. A total of 181 (84%) of the 215 women went on to complete 5 years of follow-up, and 126 (56%) completed 7 years of follow-up. The primary goals of the extended CARE study, as reported in JAMA, were to compare long-term anatomic success rates, stress continence rates, overall pelvic floor symptoms, pelvic-floor–specific quality of life (QOL), and mesh-related adverse events.

RESULTS

Treatment failure probability. Treatment failure was considered symptomatic or anatomic POP, SUI, or overall urinary incontinence score of 3 or greater on the Incontinence Severity Index. The procedure’s failure rates showed a gradual increase over the follow-up, in both the urethropexy group and the no urethropexy group.

Urethropexy vs no urethropexy. By year 7, the estimated probabilities of treatment failure for the urethropexy group versus the no urethropexy group, respectively, were:

• for anatomic POP – 0.27 versus 0.22 (treatment difference of 0.05; 95% confidence interval [CI], 0.161 to 0.271)
• for symptomatic POP – 0.29 versus 0.24 (treatment difference of 0.049; 95% CI, 0.060 to 0.162)
• for composite POP – 0.48 versus 0.34 (treatment difference of 0.134; 95% CI, 0.096 to 0.322)
• for SUI – 0.62 versus 0.77 (treatment difference of 0.153; 95% CI, 0.268 to 0.030)
• for overall urinary incontinence – 0.75 versus 0.81 (treatment difference of 0.064; 95% CI, 0.161 to 0.032).

Mesh erosion probability. By year 2, 3 of the 322 women enrolled in CARE had suture erosion and 17 had mesh erosion. There were 2 additional cases of suture erosion and 6 additional cases of mesh erosion by year 7. All types of mesh eroded. The estimated probability of mesh erosion in the CARE and extended CARE trials at the time of the last known treatment failure (6.18 years) was 10.5% (95% CI, 6.8%-16.1%).

Repeat surgery probability. By year 7, at least 36 of 215 women (16.7%) in the extended CARE trial had additional surgery related to pelvic floor disorders, 11 for recurrent POP, 14 for SUI, and 11 for mesh complications.

ABDOMINAL SACROCOLPOPEXY FOR POP IS LESS EFFECTIVE THAN DESIRED

During 7 years of follow-up, abdominal sacrocolpopexy failure rates increased in both the urethropexy group and the no urethropexy group, although urethropexy prevented SUI longer than no urethropexy. “By 5 years, nearly one-third of women met our composite failure definition,” said the authors.¹

“Based on our results,” they write, “women considering abdominal sacrocolpopexy should be counseled that this procedure effectively provides relief from POP symptoms; however, the anatomic support deteriorates over time. Adding an anti-incontinence procedure for women continent preoperatively decreases, but does not eliminate, the risk of de novo SUI. Surgical counseling about the ongoing risk of mesh-related events even for abdominal sacrocolpopexy is critical. Women should be aware that symptoms such as vaginal bleeding, discharge, and pain may be due to mesh erosion and should seek help accordingly.”¹

We want to hear from you! Tell us what you think.

More than 225,000 operations are performed each year in the United States for pelvic organ prolapse (POP). Abdominal sacrocolpopexy is considered the most durable of these procedures, but long-term outcomes need to be studied, say researchers from University of Utah School of Medicine, Salt Lake City.1 Direct costs for these procedures exceed $1 billion per year, and, as the population ages, the need to treat POP and urinary incontinence will rise.1

The original Colpopexy and Urinary Reduction Efforts (CARE) trial included 322 women without stress urinary incontinence (SUI) who underwent abdominal sacrocolpopexy between 2002 and 2005 for symptomatic POP. Because SUI is a common adverse event following POP surgery, study patients were randomly assigned to receive concomitant Burch urethropexy or no urethropexy.

Details of the study
The extended CARE study enrolled 92% (215/233) of eligible 2-year CARE trial completers. A total of 181 (84%) of the 215 women went on to complete 5 years of follow-up, and 126 (56%) completed 7 years of follow-up. The primary goals of the extended CARE study, as reported in JAMA, were to compare long-term anatomic success rates, stress continence rates, overall pelvic floor symptoms, pelvic-floor–specific quality of life (QOL), and mesh-related adverse events.

RESULTS

Treatment failure probability. Treatment failure was considered symptomatic or anatomic POP, SUI, or overall urinary incontinence score of 3 or greater on the Incontinence Severity Index. The procedure’s failure rates showed a gradual increase over the follow-up, in both the urethropexy group and the no urethropexy group.

Urethropexy vs no urethropexy. By year 7, the estimated probabilities of treatment failure for the urethropexy group versus the no urethropexy group, respectively, were:

• for anatomic POP – 0.27 versus 0.22 (treatment difference of 0.05; 95% confidence interval [CI], 0.161 to 0.271)
• for symptomatic POP – 0.29 versus 0.24 (treatment difference of 0.049; 95% CI, 0.060 to 0.162)
• for composite POP – 0.48 versus 0.34 (treatment difference of 0.134; 95% CI, 0.096 to 0.322)
• for SUI – 0.62 versus 0.77 (treatment difference of 0.153; 95% CI, 0.268 to 0.030)
• for overall urinary incontinence – 0.75 versus 0.81 (treatment difference of 0.064; 95% CI, 0.161 to 0.032).

Mesh erosion probability. By year 2, 3 of the 322 women enrolled in CARE had suture erosion and 17 had mesh erosion. There were 2 additional cases of suture erosion and 6 additional cases of mesh erosion by year 7. All types of mesh eroded. The estimated probability of mesh erosion in the CARE and extended CARE trials at the time of the last known treatment failure (6.18 years) was 10.5% (95% CI, 6.8%-16.1%).

Repeat surgery probability. By year 7, at least 36 of 215 women (16.7%) in the extended CARE trial had additional surgery related to pelvic floor disorders, 11 for recurrent POP, 14 for SUI, and 11 for mesh complications.

ABDOMINAL SACROCOLPOPEXY FOR POP IS LESS EFFECTIVE THAN DESIRED

During 7 years of follow-up, abdominal sacrocolpopexy failure rates increased in both the urethropexy group and the no urethropexy group, although urethropexy prevented SUI longer than no urethropexy. “By 5 years, nearly one-third of women met our composite failure definition,” said the authors.¹

“Based on our results,” they write, “women considering abdominal sacrocolpopexy should be counseled that this procedure effectively provides relief from POP symptoms; however, the anatomic support deteriorates over time. Adding an anti-incontinence procedure for women continent preoperatively decreases, but does not eliminate, the risk of de novo SUI. Surgical counseling about the ongoing risk of mesh-related events even for abdominal sacrocolpopexy is critical. Women should be aware that symptoms such as vaginal bleeding, discharge, and pain may be due to mesh erosion and should seek help accordingly.”¹

We want to hear from you! Tell us what you think.