Table 4.
Trial 1: Native tissue repair vs polypropylene mesh inlay | Trial 2: Native tissue repair vs biological xenograft | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Native tissue | Mesh inlay | Eff. size | 95% CI | p- value |
Native tissue | Biological xenograft | Eff. size | 95% CI | p- value |
|||||||||
4-Year outcomes | ||||||||||||||||||
No. of women at 4 years | N = 305 | N = 314 | N = 271 | N = 268 | ||||||||||||||
Prolapse compared with before surgery at 4 years | ||||||||||||||||||
Very much better | 50.4% | 143 | 284 | 47.4% | 135 | 285 | 1.22 | 0.94 to 1.58 | 0.129 | 51.6% | 132 | 256 | 44.4% | 111 | 250 | 1.46 | 1.14 to 1.87 | 0.003 |
Much better | 28.2% | 80 | 284 | 26.7% | 76 | 285 | 25.0% | 64 | 256 | 20.8% | 52 | 250 | ||||||
A little better | 10.2% | 29 | 284 | 9.8% | 28 | 285 | 11.3% | 29 | 256 | 14.8% | 37 | 250 | ||||||
No change | 4.2% | 12 | 284 | 6.0% | 17 | 285 | 4.3% | 11 | 256 | 12.0% | 30 | 250 | ||||||
A little worse | 2.8% | 8 | 284 | 3.5% | 10 | 285 | 3.9% | 10 | 256 | 6.8% | 17 | 250 | ||||||
Much worse | 2.8% | 8 | 284 | 4.2% | 12 | 285 | 3.1% | 8 | 256 | 0.8% | 2 | 250 | ||||||
Very much worse | 1.4% | 4 | 284 | 2.5% | 7 | 285 | 0.8% | 2 | 256 | 0.4% | 1 | 250 | ||||||
Satisfaction with surgery at 4 years | ||||||||||||||||||
Completely satisfied | 58.2% | 167 | 287 | 51.5% | 151 | 293 | 1.37 | 1.04 to 1.80 | 0.023 | 59.1% | 152 | 257 | 47.5% | 121 | 255 | 1.58 | 1.16 to 2.15 | 0.004 |
Fairly satisfied | 28.9% | 83 | 287 | 30.7% | 90 | 293 | 28.0% | 72 | 257 | 32.5% | 83 | 255 | ||||||
Fairly dissatisfied | 4.2% | 12 | 287 | 5.5% | 16 | 293 | 4.7% | 12 | 257 | 8.6% | 22 | 255 | ||||||
Very dissatisfied | 5.9% | 17 | 287 | 9.2% | 27 | 293 | 5.1% | 13 | 257 | 6.3% | 16 | 255 | ||||||
Not sure | 2.8% | 8 | 287 | 3.1% | 9 | 293 | 3.1% | 8 | 257 | 5.1% | 13 | 255 | ||||||
Recommend to a friend at 4 years | ||||||||||||||||||
Yes | 90.3% | 250 | 277 | 87.9% | 239 | 272 | 0.98[1] | 0.92 to 1.03 | 0.430 | 91.1% | 225 | 247 | 87.6% | 212 | 242 |
0.95 [2] |
0.91 to 0.98 | 0.003 |
6-Year outcomes | ||||||||||||||||||
No. of women at 6 years | N = 272 | N = 277 | N = 238 | N = 250 | ||||||||||||||
Prolapse compared with before surgery at 6 years | ||||||||||||||||||
Very much better | 46.7% | 119 | 255 | 41.9% | 111 | 265 | 1.41 | 1.07 to 1.86 | 0.016 | 45.2% | 100 | 221 | 37.6% | 88 | 234 | 1.36 | 0.93 to 1.98 | 0.113 |
Much better | 30.6% | 78 | 255 | 27.2% | 72 | 265 | 29.4% | 65 | 221 | 29.9% | 70 | 234 | ||||||
A little better | 9.0% | 23 | 255 | 8.7% | 23 | 265 | 10.4% | 23 | 221 | 12.8% | 30 | 234 | ||||||
No change | 6.3% | 16 | 255 | 8.7% | 23 | 265 | 6.8% | 15 | 221 | 8.1% | 19 | 234 | ||||||
A little worse | 4.3% | 11 | 255 | 7.2% | 19 | 265 | 4.5% | 10 | 221 | 6.4% | 15 | 234 | ||||||
Much worse | 2.0% | 5 | 255 | 2.6% | 7 | 265 | 1.8% | 4 | 221 | 3.8% | 9 | 234 | ||||||
Very much worse | 1.2% | 3 | 255 | 3.8% | 10 | 265 | 1.8% | 4 | 221 | 1.3% | 3 | 234 | ||||||
Satisfaction with surgery at 6 years | ||||||||||||||||||
Completely satisfied | 55.4% | 144 | 260 | 42.9% | 115 | 268 | 1.67 | 1.31 to 2.13 | 0.000 | 54.8% | 125 | 228 | 46.2% | 108 | 234 | 1.26 | 0.85 to 1.87 | 0.255 |
Fairly satisfied | 30.4% | 79 | 260 | 35.4% | 95 | 268 | 29.4% | 67 | 228 | 35.0% | 82 | 234 | ||||||
Fairly dissatisfied | 3.1% | 8 | 260 | 8.6% | 23 | 268 | 3.1% | 7 | 228 | 8.5% | 20 | 234 | ||||||
Very dissatisfied | 5.8% | 15 | 260 | 8.6% | 23 | 268 | 5.3% | 12 | 228 | 6.4% | 15 | 234 | ||||||
Not sure | 5.4% | 14 | 260 | 4.5% | 12 | 268 | 7.5% | 17 | 228 | 3.8% | 9 | 234 | ||||||
Recommend to a friend at 6 years | ||||||||||||||||||
Yes | 89.0% | 219 | 246 | 84.8% | 217 | 256 | 0.93[3] | 0.90 to 0.98 | 0.002 | 89.7% | 192 | 214 | 85.2% | 184 | 216 |
0.95 [2] |
0.90 to 1.01 | 0.084 |
Footnotes:
1. Concomitant upper prolapse procedure excluded because of nil group counts
2. Type of prolapse planned, concomitant incontinence and concomitant upper prolapse procedure excluded because of nil group counts
3. Concomitant incontinence and concomitant upper prolapse procedure excluded because of nil group counts