Midurethral sling study: At 5 years satisfaction remained high, though continence declined

ORLANDO – Success rates at 5 years were similar in women treated with a transobturator midurethral sling and women treated with a retropubic midurethral sling, but the transobturator patients were more likely to report an easing of symptoms, according to an extension of the Trial of Mid-Urethral Slings.

Overall satisfaction was similar in the two groups, Dr. Leslie M. Rickey reported during a Best Abstract session at the annual meeting of the American Urological Association.

Of 597 subjects in the Trial of Midurethral Slings (TOMUS), 404 participated in the extension phase (E-TOMUS). There was no significant difference in success rates – which declined over time – between those in the transobturator group and those in the retropubic group (43% vs. 51%). However, treatment success for retropubic midurethral slings was nearly 8% higher and did not meet equivalency criteria at 1 or 5 years, said Dr. Rickey, a urologist at Yale University, New Haven, Conn., who presented on behalf of Dr. Kimberly S. Kenton and the Urinary Incontinence Treatment Network.

Stress incontinence symptoms continued to increase over time in both groups but did not differ between the groups at 5 years; urge symptoms also increased over time but were reported significantly more often in the retropubic midurethral sling group.

"Overall urgency symptoms and sexual dysfunction, although still improved from baseline, did worsen over time," Dr. Rickey said, noting that they worsened significantly more overall in the retropubic group.

However, the proportion of patients who were completely or mostly satisfied remained similar in the groups (although it decreased from 92% and 93% to 80% and 85% in the groups, respectively, over time). Those in the transobturator group were almost twice as likely to report improvement in their urinary condition as measured by the Patient Global Impression of Improvement scale (odds ratio, 1.94), Dr. Rickey said.

With respect to adverse events, 10% of women overall experienced an adverse event (mainly urinary tract infections or mesh exposure) or serious adverse event; the rate did not differ between the groups. There were six serious adverse events requiring intervention, including one case of mesh erosion in each group and four urinary tract infections in the retropubic midurethral sling group.

"Importantly, there were seven new mesh exposures in years 3-5 after surgery," Dr. Rickey said, noting that three occurred in the retropubic midurethral sling group and four occurred in the transobturator midurethral sling group.

Women included in the extension phase were TOMUS participants who did not undergo surgical retreatment for stress urinary incontinence after the initial procedure. Participants completed annual in-person visits, including pelvic examination, symptom, mesh, and quality of life questionnaires.

Treatment success was defined as no retreatment for stress urinary incontinence, and no self-reported stress urinary incontinence symptoms using the Medical, Epidemiological, and Social Aspects of Aging questionnaire, she said.

"In conclusion, the 5-year continence rates did decline after either retropubic midurethral sling or transobturator sling, and did not meet prespecified criteria for equivalency. Satisfaction does remain high in both groups. In general, urinary symptoms and quality of life were more improved at 5 years after the transobturator approach, and mesh erosion rates remain low at 1.7%," she said.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors reported having no disclosures.

ORLANDO – Success rates at 5 years were similar in women treated with a transobturator midurethral sling and women treated with a retropubic midurethral sling, but the transobturator patients were more likely to report an easing of symptoms, according to an extension of the Trial of Mid-Urethral Slings.

Overall satisfaction was similar in the two groups, Dr. Leslie M. Rickey reported during a Best Abstract session at the annual meeting of the American Urological Association.

Of 597 subjects in the Trial of Midurethral Slings (TOMUS), 404 participated in the extension phase (E-TOMUS). There was no significant difference in success rates – which declined over time – between those in the transobturator group and those in the retropubic group (43% vs. 51%). However, treatment success for retropubic midurethral slings was nearly 8% higher and did not meet equivalency criteria at 1 or 5 years, said Dr. Rickey, a urologist at Yale University, New Haven, Conn., who presented on behalf of Dr. Kimberly S. Kenton and the Urinary Incontinence Treatment Network.

Stress incontinence symptoms continued to increase over time in both groups but did not differ between the groups at 5 years; urge symptoms also increased over time but were reported significantly more often in the retropubic midurethral sling group.

"Overall urgency symptoms and sexual dysfunction, although still improved from baseline, did worsen over time," Dr. Rickey said, noting that they worsened significantly more overall in the retropubic group.

However, the proportion of patients who were completely or mostly satisfied remained similar in the groups (although it decreased from 92% and 93% to 80% and 85% in the groups, respectively, over time). Those in the transobturator group were almost twice as likely to report improvement in their urinary condition as measured by the Patient Global Impression of Improvement scale (odds ratio, 1.94), Dr. Rickey said.

With respect to adverse events, 10% of women overall experienced an adverse event (mainly urinary tract infections or mesh exposure) or serious adverse event; the rate did not differ between the groups. There were six serious adverse events requiring intervention, including one case of mesh erosion in each group and four urinary tract infections in the retropubic midurethral sling group.

"Importantly, there were seven new mesh exposures in years 3-5 after surgery," Dr. Rickey said, noting that three occurred in the retropubic midurethral sling group and four occurred in the transobturator midurethral sling group.

Women included in the extension phase were TOMUS participants who did not undergo surgical retreatment for stress urinary incontinence after the initial procedure. Participants completed annual in-person visits, including pelvic examination, symptom, mesh, and quality of life questionnaires.

Treatment success was defined as no retreatment for stress urinary incontinence, and no self-reported stress urinary incontinence symptoms using the Medical, Epidemiological, and Social Aspects of Aging questionnaire, she said.

"In conclusion, the 5-year continence rates did decline after either retropubic midurethral sling or transobturator sling, and did not meet prespecified criteria for equivalency. Satisfaction does remain high in both groups. In general, urinary symptoms and quality of life were more improved at 5 years after the transobturator approach, and mesh erosion rates remain low at 1.7%," she said.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors reported having no disclosures.

ORLANDO – Success rates at 5 years were similar in women treated with a transobturator midurethral sling and women treated with a retropubic midurethral sling, but the transobturator patients were more likely to report an easing of symptoms, according to an extension of the Trial of Mid-Urethral Slings.

Overall satisfaction was similar in the two groups, Dr. Leslie M. Rickey reported during a Best Abstract session at the annual meeting of the American Urological Association.

Of 597 subjects in the Trial of Midurethral Slings (TOMUS), 404 participated in the extension phase (E-TOMUS). There was no significant difference in success rates – which declined over time – between those in the transobturator group and those in the retropubic group (43% vs. 51%). However, treatment success for retropubic midurethral slings was nearly 8% higher and did not meet equivalency criteria at 1 or 5 years, said Dr. Rickey, a urologist at Yale University, New Haven, Conn., who presented on behalf of Dr. Kimberly S. Kenton and the Urinary Incontinence Treatment Network.

Stress incontinence symptoms continued to increase over time in both groups but did not differ between the groups at 5 years; urge symptoms also increased over time but were reported significantly more often in the retropubic midurethral sling group.

"Overall urgency symptoms and sexual dysfunction, although still improved from baseline, did worsen over time," Dr. Rickey said, noting that they worsened significantly more overall in the retropubic group.

However, the proportion of patients who were completely or mostly satisfied remained similar in the groups (although it decreased from 92% and 93% to 80% and 85% in the groups, respectively, over time). Those in the transobturator group were almost twice as likely to report improvement in their urinary condition as measured by the Patient Global Impression of Improvement scale (odds ratio, 1.94), Dr. Rickey said.

With respect to adverse events, 10% of women overall experienced an adverse event (mainly urinary tract infections or mesh exposure) or serious adverse event; the rate did not differ between the groups. There were six serious adverse events requiring intervention, including one case of mesh erosion in each group and four urinary tract infections in the retropubic midurethral sling group.

"Importantly, there were seven new mesh exposures in years 3-5 after surgery," Dr. Rickey said, noting that three occurred in the retropubic midurethral sling group and four occurred in the transobturator midurethral sling group.

Women included in the extension phase were TOMUS participants who did not undergo surgical retreatment for stress urinary incontinence after the initial procedure. Participants completed annual in-person visits, including pelvic examination, symptom, mesh, and quality of life questionnaires.

Treatment success was defined as no retreatment for stress urinary incontinence, and no self-reported stress urinary incontinence symptoms using the Medical, Epidemiological, and Social Aspects of Aging questionnaire, she said.

"In conclusion, the 5-year continence rates did decline after either retropubic midurethral sling or transobturator sling, and did not meet prespecified criteria for equivalency. Satisfaction does remain high in both groups. In general, urinary symptoms and quality of life were more improved at 5 years after the transobturator approach, and mesh erosion rates remain low at 1.7%," she said.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors reported having no disclosures.