Table 2.
Pelvic Organ Prolapse Failure Definition | Treatment Group | Estimated Probability of Failure (SE)1, Number2/Denominator2, Difference in Treatment Estimates and 95% Confidence Intervals | |||||
---|---|---|---|---|---|---|---|
2 Years | 3 Years | 4 Years | 5 Years | 6 Years | 7 Years | ||
Symptomatic3 | Burch | 0.14 (0.026) | 0.18 (0.031) | 0.21 (0.034) | 0.24 (0.038) | 0.27 (0.041) | 0.29 (0.043) |
15/104 | 16/101 | 19/94 | 25/91 | 27/86 | 27/73 | ||
No Burch | 0.12 (0.023) | 0.15 (0.027) | 0.18 (0.031) | 0.20 (0.034) | 0.22 (0.036) | 0.24 (0.038) | |
16/111 | 19/108 | 20/103 | 21/96 | 21/90 | 22/71 | ||
Treatment Difference | 0.026 (−0.032, 0.087) | 0.032 (−0.040, 0.108) | 0.038 (−0.046, 0.124) | 0.042 (−0.051, 0.139) | 0.046 (−0.056, 0.151) | 0.049 (−0.060, 0.162) | |
Anatomic (Original)4 | Burch | 0.08 (0.027) | 0.12 (0.39) | 0.16 (0.049) | 0.20 (0.059) | 0.23 (0.068) | 0.26 (0.075) |
6/69 | 9/61 | 10/49 | 12/47 | 15/44 | 15/33 | ||
No Burch | 0.10 (0.029) | 0.13 (0.034) | 0.16 (0.039) | 0.19 (0.043) | 0.21 (0.047) | 0.23 (0.050) | |
9/76 | 10/67 | 12/63 | 13/59 | 14/47 | 14/37 | ||
Treatment Difference | −0.017 (−0.098, 0.061) | −0.010 (−0.112, 0.093) | −0.001 (−0.123, 0.125) | 0.009 (−0.133, 0.154) | 0.019 (−0.140, 0.182) | 0.029 (−0.148, 0.208) | |
Anatomic (Updated)5 | Burch | 0.09 (0.036) | 0.13 (0.052) | 0.16 (0.066) | 0.20 (0.078) | 0.24 (0.089) | 0.27 (0.099) |
5/69 | 8/60 | 10/48 | 14/46 | 18/44 | 18/35 | ||
No Burch | 0.09 (0.028) | 0.12 (0.033) | 0.15 (0.037) | 0.17 (0.041) | 0.20 (0.045) | 0.22 (0.049) | |
8/76 | 10/66 | 12/63 | 12/59 | 13/48 | 13/38 | ||
Treatment Difference | −0.005 (−0.093, 0.087) | 0.005 (−0.110, 0.131) | 0.016 (−0.125, 0.170) | 0.028(−0.139, 0.207) | 0.039(−0.150, 0.240) | 0.050(−0.161, 0.271) | |
Composite6 | Burch | 0.22 (0.056) | 0.29 (0.066) | 0.34 (0.074) | 0.39 (0.081) | 0.44 (0.087) | 0.48 (0.092) |
14/70 | 16/63 | 19/52 | 27/51 | 30/49 | 30/42 | ||
No Burch | 0.18 (0.038) | 0.23 (0.042) | 0.26 (0.046) | 0.29 (0.049) | 0.32 (0.052) | 0.34 (0.054) | |
15/76 | 18/66 | 19/62 | 20/59 | 21/51 | 21/45 | ||
Treatment Difference | 0.035 (−0101, 0.164) | 0.060 (−0.102, 0.207) | 0.082 (−0.101, 0.244) | 0.102 (−0.099, 0.276) | 0.119 (−0.098, 0.304) | 0.134 (−0.096, 0.322) | |
Urinary Incontinence Failure Definition | Treatment Group | Estimated Probability of Failure (SD)1, Number2/Denominator2, Difference in Treatment Estimates and 95% Confidence Intervals | |||||
2 Years | 3 Years | 4 Years | 5 Years | 6 Years | 7 Years | ||
Overall UI7 | Burch | 0.59 (0.050) | 0.65 (0.048) | 0.68 (0.047) | 0.71 (0.045) | 0.73 (0.044) | 0.75 (0.043) |
48/104 | 52/101 | 55/99 | 58/98 | 59/97 | 62/91 | ||
No Burch | 0.67 (0.039) | 0.72 (0.038) | 0.76 (0.036) | 0.78 (0.035) | 0.80 (0.033) | 0.81 (0.032) | |
66/111 | 70/109 | 70/105 | 72/104 | 73/102 | 73/92 | ||
Treatment Difference | −0.082 (−0.203, 0.041) | −0.077 (−0.192, 0.038) | −0.073 (−0.183, 0.036) | −0.070 (−0.174, 0.034) | −0.067 (−0.168, 0.033) | −0.064 (−0.161, 0.032) | |
SUI Prevention Failure7 | Burch | 0.44 (0.052) | 0.50 (0.053) | 0.54 (0.053) | 0.57 (0.052) | 0.60 (0.052) | 0.62 (0.051) |
39/104 | 47/102 | 49/99 | 53/98 | 55/95 | 57/89 | ||
No Burch | 0.61 (0.039) | 0.67 (0.038) | 0.71 (0.037) | 0.73 (0.036) | 0.75 (0.035) | 0.77 (0.034) | |
63/110 | 69/109 | 76/107 | 77/105 | 78/105 | 79/96 | ||
Treatment Difference | −0.175 (−0.296, −0.043) | −0.172 (−0.291, −0.042) | −0.168 (−0.284, −0.041) | −0.163 (−0.278, −0.039) | −0.158 (−0.271, −0.038) | −0.154 (−0.266, −0.037) | |
SUI7 | Burch | 0.44 (0.053) | 0.49 (0.054) | 0.54 (0.054) | 0.57 (0.053) | 0.60 (0.053) | 0.62 (0.052) |
39/104 | 47/102 | 49/99 | 53/98 | 55/95 | 57/89 | ||
No Burch | 0.61 (0.039) | 0.67 (0.038) | 0.70 (0.037) | 0.73 (0.036) | 0.75 (0.035) | 0.77 (0.034) | |
63/110 | 68/109 | 75/107 | 76/105 | 78/105 | 79/96 | ||
Treatment Difference | −0.173 (−0.298, −0.035) | −0.170 (−0.295, −0.034) | −0.166 (−0.288, −0.033) | −0.161 (−0.281, −0.032) | −0.157 (−0.275, −0.030) | −0.153 (−0.268, −0.030) |
Estimated Probability of Failure estimates and corresponding standard errors are from the parametric survival models (demonstrated in eFigures 1–3).
Numerators and denominators at each time point include prior failures and exclude prior drop-outs who had not yet met failure criteria
Symptom of bulge on Pelvic Floor Distress Inventory OR interval prolapse surgery OR pessary used after index surgery
TVL + C > 2 cm OR one of points Ba or Bp > +1 cm
C > ( −2/3 x TVL) OR one of points Ba or Bp > 0 cm
Anatomic (updated definition) OR symptomatic failure
SUI=Stress Urinary Incontinence; UI=Urinary Incontinence
NOTE: The original and updated versions of the anatomic failure could have different denominators for the same time point; this is because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether they have completed the visits.