Table 2. Population as Randomized and Per-Protocol Analysis of the Primary and Secondary Outcomes at 24 Months.
| Population as randomized | Per-protocol analysis | |||||||
|---|---|---|---|---|---|---|---|---|
| Group, mean (SD)a | Difference (95% CI) | P value | Group, mean (SD)a | Difference (95% CI) | P value | |||
| Surgery (n=162) | Pessary (n=173) | Surgery (n=150)b | Pessary (n=74)b | |||||
| Primary outcome | ||||||||
| PGI-I: improvement, No./total (%)c | 132/162 (81.5) | 132/173 (76.3) | −6.1% (−12.7 to ∞)d | .16e | 125/150 (83.3) | 52/74 (70.3) | −13.1% (−23.0 to ∞)d | .69e |
| Secondary outcomes | ||||||||
| PGI-S: improvement, No./total (%) | 134/157 (85.4) | 121/162 (74.7) | −10.7% (−19.3 to −2.0)d | .02f | 125/145 (86.2) | 50/70 (71.4) | −14.7% (−20.2 to −9.1)d | .005f |
| Change in PFDI-20 domain scoreg | (n=162) | (n=170) | (n=150) | (n=74) | ||||
| POPDI-6 | −23.3 (15.3) | −21.6 (22.1) | 1.7 (−2.4 to 5.8)h | .41 | −23.9 (15.2) | −19.9 (21.5) | 4.0 (−1.4 to 9.4)h | .15 |
| CRADI-8 | −3.9 (13.2) | −3.5 (13.4) | 0.4 (−2.4 to 3.3)h | .78 | −4.4 (13.1) | −2.5 (12.3) | 1.9 (−1.7 to 5.4)h | .30 |
| UDI-6 | −13.7 (19.4) | −10.7 (20.6) | 3.0 (−1.2 to 7.3)h | .16 | −13.9 (19.6) | −8.1 (18.8) | 5.8 (0.5 to 11.1)h | .03 |
| Irritative | NA | NA | NA | NA | −18.1 (29.0) | −12.7 (30.3) | 5.4 (−2.8 to 13.7)h | .19 |
| Stress | NA | NA | NA | NA | −3.3 (24.3) | 0.7 (22.4) | 4.0 (−2.6 to 10.7)h | .23 |
| Obstructive/discomfort | NA | NA | NA | NA | −20.4 (26.3) | −12.2 (23.6) | 8.2 (1.1 to 15.4)h | .02 |
| PFDI-20 total score | −41.0 (37.1) | −35.7 (44.4) | 5.3 (−3.4 to 14.0)h | .24 | −42.2 (37.6) | −30.4 (39.3) | 11.8 (0.5 to 22.3)h | .04 |
| Change in PFIQ-7 domain scorei | (n=160) | (n=169) | (n=148) | (n=72) | ||||
| UIQ-7 | −10.7 (17.4) | −10.2 (20.0) | 0.5 (−3.5 to 4.4)h | .81 | −10.8 (17.4) | −10.6 (18.6) | 0.2 (−4.9 to 5.3)h | .93 |
| CRAIQ-7 | −2.6 (12.9) | −3.2 (13.4) | −0.6 (−3.5 to 2.1)h | .65 | −2.5 (12.3) | −1.7 (10.4) | 0.8 (−2.3 to 3.9)h | .61 |
| POPIQ-7 | −12.3 (20.4) | −11.6 (19.8) | 0.7 (−3.6 to 5.0)h | .73 | −12.8 (20.7) | −11.4 (20.5) | 1.4 (−4.4 to 7.1)h | .63 |
| PFIQ-7 total score | −25.5 (40.5) | −24.8 (44.6) | 0.7 (−8.5 to 10.0)h | .88 | −26.0 (40.8) | −22.9 (38.6) | 3.1 (−8.2 to 14.0)h | .59 |
| Change in PISQ-IR sexually active, domain scorej | (n=69) | (n=78) | (n=65) | (n=30) | ||||
| Partner-related: indicates assessment of partner-related impacts | −0.04 (0.5) | 0.06 (0.5) | 0.10 (−0.04 to 0.26)h | .17 | −0.07 (0.5) | 0.15 (0.5) | 0.22 (0.03 to 0.4)h | .04 |
| Condition-specific: indicates assessment of comdition-specific impacts on activity | 0.12 (0.5) | 0.13 (0.5) | 0.01 (−0.15 to 0.17)h | .91 | 0.11 (0.5) | 0.11 (0.5) | 0.00 (−0.2 to 0.2)h | .98 |
| Global quality: indicates global quality rating of sexual quality | −0.12 (0.6) | −0.08 (0.5) | 0.04 (−0.13 to 0.22)h | .62 | −0.10 (0.6) | −0.10 (0.5) | 0.00 (−0.2 to 0.2)h | .98 |
| Condition impact: indicates condition-specific impact on sexual quality | 0.51 (0.7) | 0.31 (0.6) | −0.20 (−0.41 to 0.00)h | .05 | 0.48 (0.7) | 0.28 (0.5) | −0.20 (−0.4 to 0.04)h | .11 |
| Arousal-orgasm: indicates assessment of arousal, orgasm | 0.06 (0.5) | 0.09 (0.5) | 0.03 (−0.13 to 0.20)h | .68 | 0.05 (0.5) | 0.13 (0.5) | 0.08 (−0.1 to 0.3)h | .49 |
| Desire: indicates assessment of sexual desire | −0.06 (0.5) | −0.04 (0.6) | 0.02 (−0.15 to 0.19)h | .77 | −0.09 (0.5) | −0.02 (0.7) | 0.07 (−0.2 to 0.3)h | .63 |
| Summary score | 0.08 (0.3) | 0.08 (0.3) | 0.00 (−0.08 to 0.09)h | .95 | 0.07 (0.3) | 0.09 (0.2) | 0.02 (−0.09 to 0.1)h | .73 |
| Change in PISQ-IR not sexually active, domain scorek | (n=58) | (n=50) | (n=52) | (n=27) | ||||
| Partner-related: indicates partner-related reasons for not being active | −0.06 (1.0) | 0.23 (0.8) | 0.29 (−0.04 to 0.62)h | .10 | −0.04 (1.0) | 0.19 (0.8) | 0.23 (−0.1 to 0.6)h | .28 |
| Condition-specific: indicates condition-specific reasons for not being active | −0.12 (0.9) | 0.05 (1.1) | 0.17 (−0.21 to 0.56)h | .39 | −0.13 (1.0) | 0.05 (1.1) | 0.18 (−0.3 to 0.6)h | .48 |
| Global quality: indicates indicates global quality rating of sexual quality | −0.01 (0.6) | 0.17 (0.6) | 0.18 (−0.05 to 0.42)h | .14 | 0.02 (0.6) | 0.19 (0.7) | 0.17 (−0.1 to 0.5)h | .28 |
| Condition impact: indicates condition impact on sexual quality | −0.27 (0.7) | −0.09 (0.7) | 0.18 (−0.08 to 0.46)h | .18 | −0.29 (0.7) | −0.12 (0.9) | 0.17 (−0.2 to 0.6)h | .40 |
Abbreviations: CRADI-8, Colorectal-Anal Distress Inventory; CRAIQ-7, Colorectal-Anal Impact Questionnaire; NA, not applicable; PFDI-20, Pelvic Floor Distress Inventory; PFIQ-7, Pelvic Floor Impact Questionnaire; PGI-I, Patient Global Impression of Improvement; PGI-S, Patient Global Impression of Severity; PISQ-IR, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA [International Urogynecological Association]-Revised; POPDI-6, Pelvic Organ Prolapse Distress Inventory; POPIQ-7, Pelvic Organ Prolapse Impact Questionnaire; UDI-6, Urinary distress Inventory, Short Form; UIQ-7, Urinary Impact Questionnaire.
Data are reported as mean (SD) unless otherwise stated. Ranges, anchors and minimally clinical important differences for the outcomes can be found in Table 1. Results of the observational cohort can be found in a published article.4
Explanation for the number of women in the per-protocol analysis: the surgery group excludes women who did not undergo surgery (22), had repeat surgery because of a recurrence of prolapse (4), had repeat surgery because of de novo urinary incontinence (1) and who additionally used a pessary because of a recurrent prolapse (4); the pessary group excludes women who later also had surgery (118), stopped pessary therapy (5) and those for whom it was unknown if they used a pessary (14).
Responses range from very much better to very much worse on a 7-point Likert scale.
Values indicate risk difference. Differences for PGI-I are reported with a 1-sided 95% CI.
Analysis used the Farrington-Manning test for noninferiority against the noninferiority margin of −10%.
Analysis used the χ2 test, risk difference 95% CI.
A negative change indicates improvement.
Values indicate mean difference with a 2-sided bootstrapped 95% CI for the difference of means.
A negative change indicates improvement.
An increase in the delta of change indicates less impact on female sexual functioning and better sexual functioning.
A decrease in the delta of change indicates less impact of pelvic organ prolapse on sexual inactivity.