Table 3.
Outcomes for pelvic organ prolapse at 12 month follow-up. Values are numbers (percentages) of women unless stated otherwise
| Outcomes | Sacrospinous hysteropexy | Vaginal hysterectomy | Difference (95% CI) |
|---|---|---|---|
| Primary outcome* | |||
| ITT analysis with LOCF | 0/102 (0) | 4/100 (4) | −3.9 (−8.6 to 0.7) |
| ITT analysis with conservative imputation | 6/103 (6) | 10/105 (10) | −3.6 (−11.2 to 3.9) |
| Per protocol analysis | 0/98 (0) | 3/90 (3) | −3.3 (−8.0 to 1.3) |
| Overall surgical failure† | |||
| ITT analysis with LOCF | 52/102 (51) | 49/100 (49) | 1.9 (−11.8 to 15.7) |
| ITT analysis with conservative imputation | 55/103 (53) | 54/105 (51) | 1.9 (−11.6 to 15.5) |
| Per protocol analysis | 51/98 (52) | 44/90 (49) | 3.1 (−11.2 to 17.4) |
| Composite outcome success‡ | |||
| ITT analysis with LOCF | 91/102 (89) | 83/100 (83) | 6.1 (−3.6 to 15.8) |
| ITT analysis with conservative imputation | 87/103 (84) | 82/105 (78) | 6.2 (−4.5 to 16.9) |
| Per protocol analysis | 87/98 (89) | 75/90 (83) | 5.3 (−4.7 to 15.5) |
| Anatomical failure§ | |||
| Overall anatomical failure: | 51/101 (50) | 44/100 (44) | 6.4 (−7.4 to 20.1) |
| Apical compartment | 2/102 (2) | 7/100 (7) | −5.0 (−11.1 to 1.2) |
| Anterior compartment | 47/101 (47) | 33/99 (33) | 12.9 (−0.5 to 26.4) |
| Posterior compartment | 4/101 (4) | 14/99 (14) | −10.0 (−18.2 to −1.8) |
| Prolapse beyond hymen¶ | |||
| Apical (POP-Q C >0) | 0/102 (0) | 4/100 (4) | −3.9 (−8.6 to 0.7) |
| Anterior (POP-Q Ba >0) | 8/101 (8) | 6/99 (6) | 1.8 (−5.6 to 9.2) |
| Posterior (POP-Q Bp >0) | 0/101 (0) | 2/99 (2) | −2.0 (−5.9 to 1.9) |
| Repeat surgery¶ | |||
| Recurrent prolapse | 1/102 (1) | 4/102 (4) | −2.9 (−7.8 to 2.0) |
| Apical compartment | 0/102 (0) | 2/102 (2) | −1.9 (−5.7 to 1.8) |
| Anterior compartment | 1/102 (1) | 4/102 (4) | −2.9 (−7.8 to 2.0) |
| Posterior compartment | 0/102 (0) | 1/102 (1) | −1.0 (−4.2 to 2.3) |
| Primary surgery different site** | 0/102 (0) | 3/102 (3) | −2.9 (−7.1 to 1.3) |
| Surgery for non-prolapse conditions | |||
| Anti-incontinence | 1/102 (1) | 4/102 (4) | −2.9 (−7.8 to 2.0) |
| Hysterectomy | 2/100 (2) | — | — |
ITT=intention to treat; LOCF=last observation carried forward; POP-Q=pelvic organ prolapse quantification.
Percentages were calculated using non-missing data. Agresti-Coull method used to calculate 95% confidence intervals.31
*Recurrent apical prolapse stage ≥2 with bothersome symptoms or repeat surgery for apical prolapse.
†Prolapse POP-Q stage ≥2 (any compartment) or repeat surgery or pessary use.
‡No prolapse beyond hymen, absence of bothersome bulge symptoms, and no repeat surgery or pessary use.
§Prolapse POP-Q stage ≥2
¶ITT with LOCF.
**Reoperation for pelvic organ prolapse in non-operated compartment.