Table 3.
Primary and secondary outcomes at 7 years
| Mesh | Native tissue | Risk difference (95% CI) | |
|---|---|---|---|
| Primary outcome | |||
| Composite success overall | |||
| • Participants, n [% (95% CI)] | 31/58 [53 (41, 66)] | 37/69 [54 (42, 65)] | −1 (−18, 17) |
| • Estimated % (95% CI) after MIa | 53 (40, 66) | 54 (43, 65) | −1 (−18, 16) |
| • Estimated % (95% CI) after MIb | 51 (38, 64) | 50 (39, 61) | −1 (−17, 16) |
| Change in composite success between 1 and 7 years | |||
| % (95% CI) of 7-year participant data | −22 (−39, −5) | −20 (−37, −4) | 2 (−12, 16) |
| Composite failures | 27/58 (47) | 32/69 (46) | 1 (−17, 18) |
| • Failure in treated compartment | 3/58 (5) | 18/69 (26) | −21* (−33, −9) |
| • Failure in untreated compartment | 17/58 (29) | 5/69 (7) | 22* (9, 35) |
| • Failure due to bulge but no POP > hymen | 5/58 (9) | 1/69 (1) | 7 (−1, 15) |
| • Failure due to bulge (questionnaire only) | 2/58 (3) | 8/69 (12) | −8 (−17, 1) |
| Secondary outcomes | |||
| Reoperation for POP | 14c/56 (25) | 11d/69 (16) | 9 (−5, 23) |
| • In treated compartment | 1 (7) | 9 (82) | −75* (−100, −48) |
| • In nontreated compartment | 13 (93) | 2 (18) | 75* (48, 100) |
| POP ≥ stage II | 28/53 (53) | 47/67 (70) | −17 (−35, 0) |
| Reoperation for POP and/or POP-Q ≥ stage II | 35/56 (62) | 53/69 (77) | −15 (−30, 2) |
| POP > hymen | 8/53 (15) | 12/67 (18) | −3 (−16, 10) |
| POP > hymen, no sensation of bulge | 4/53 (8) | 7/67 (10) | −3 (−13,7) |
| Reoperation for POP and/or POP > hymen | 22/58 (38) | 23/69 (33) | 5 (−12, 21) |
| Subjective outcomes | |||
| • Sensation of bulge | 14/66 (21) | 17/76 (22) | −1 (−14,19) |
| • PGI-I (much to very much better) | 42/60 (70) | 41/72 (57) | 13 (−3, 29) |
Data presented as n (%), n [% (95% CI)], or % (95% CI)
POP pelvic organ prolapse, PGI-I Patient Global Impression of Improvement, MI multiple imputation of missing data,
a MI excluding deceased patients
b MI with failures for missings of deceased patients
c Nine patients received another mesh
d Nine patients received mesh
*This difference would be statistically significant if tested at a significance level of 0.05