Table 8.
Adverse events at 7 years
| Mesh | Native tissue | Risk difference (95% CI) | |
|---|---|---|---|
| De novo SUI | 12/62 (19) | 8/66 (12) | 7 (−5, 20) |
| Graft-related adverse eventsa | |||
| • Exposure | 22/53 (42) | 4/67 (6)b | 36* (21, 50) |
| • Retraction mesh during examination | 17/53 (32) | 2/67 (3) | 29* (16, 42) |
| • Reoperation for complication | 8/53 (15) | 4/68 (6) | 9 (−2, 20) |
| • Reoperation for exposure | 7/53 (13) | 0/68 (0) | 13* (4, 22) |
| Pain and dyspareunia | |||
| Indicated at the outpatient visit | |||
| Pain | 8 (15) | 20 (30) | −15 (−30, 0) |
| Dyspareunia | 14 (26) | 15 (22) | 4 (−12, 20) |
| Pain and/or dyspareunia | 17 (32) | 29 (43) | −11 (−28, 6) |
| Location of pain | |||
| • Vulvar | 1 (6) | 2 (7) | −1 (−16, 14) |
| • Vaginal | 1 (6) | 5 (17) | −11 (−29, 6) |
| • Lower abdomen | 4 (24) | 8 (28) | −4 (−30, 22) |
| • Lower back | 0 (0) | 4 (14) | −14 (−26, 0) |
| • Other | 11 (65) | 10 (34) | 29* (2, 59) |
| VAS (spontaneous pain) | 1.4 ± 2.3 | 2.0 ± 2.3 | −0.6 (−2.0, 0.8) |
| VAS (during physical activity) | 2.0 ± 3.1 | 2.3 ± 2.5 | −0.3 (−2.0, 1.4) |
| VAS (during sexual intercourse) | 4.6 ± 3.6 | 2.7 ± 3.3 | 1.9 (−0.2, 4.0) |
| During gynecological examination | |||
| Provoked pain | 24 (45) | 16 (24) | 21* (5, 38) |
| • Apical | 12 (50) | 11 (69) | −19 (−49, 12) |
| • Mesh arms (distal/proximal) | 8 (33) | 2 (12) | 21 (−4, 46) |
| • Deep ligament | 1 (4) | 1 (6) | −2 (−16, 12) |
| • Other | 3 (12) | 2 (12) | 0 (−21, 21) |
| VAS (patient) | 5.2 ± 2.1 | 5.3 ± 2.2 | −0.1 (−1.5, 1.3) |
| VAS (subjective impression of examiner) | 5.3 ± 2.2 | 4.8 ± 2.1 | 0.5 (−0.9, 1.9) |
| Indicated on questionnaire | |||
| Dyspareunia during sexual intercourse | 13/64 (20) | 12/72 (17) | 3 (−9, 17) |
| • Somewhat | 5 (38) | 6 (50) | −12 (−50, 27) |
| • Moderately | 4 (31) | 4 (33) | −2 (−39, 34) |
| • Quite a bit | 4 (31) | 2 (17) | 14 (−19, 47) |
Data presented as numbers (%) or mean ± standard deviation (SD) and mean (95% CI)
SUI stress urinary incontinence, VAS visual analog scale, CI confidence interval
aCumulative up to 7 years; more details on graft-related adverse events and morbidity are shown in the “Addendum”
bExposure of Prolene thread in sacrospinous ligament fixation (1), exposure after midurethral sling for incontinence (1), exposures of mesh inserted for POP recurrence after index surgery (2)
*This difference would be statistically significant if tested at a significance level of 0.05