Table 5.
Further treatment required at 4 and 6 years
| 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 | ||||||||||||||
| New prolapse operation 1 | 4.0% | 12 | 299 | 2.9% | 9 | 311 | 0.76 | 0.36 to 1.61 | 0.471 | 3.0% | 8 | 264 | 4.5% | 12 | 266 | 1.44 | 0.77 to 2.67 | 0.253 |
| Continence surgery | 2.0% | 6 | 300 | 0.7% | 2 | 307 | 0.35 | 0.07 to 1.75 | 0.202 | 1.1% | 3 | 268 | 0.4% | 1 | 267 | 0.31 | 0.03 to 3.07 | 0.319 |
| -SUI 2 | 1.3% | 4 | 300 | 0.7% | 2 | 307 | 0.4% | 1 | 268 | .% | . | 267 | ||||||
| -UI 3 | 0.7% | 2 | 300 | .% | . | 307 | 0.7% | 2 | 268 | 0.4% | 1 | 267 | ||||||
| Mesh removed 4 | 1.1% | 3 | 285 | 3.9% | 12 | 305 | 3.42 | 1.01 to 11.60 | 0.049 | 0.8% | 2 | 259 | 0.4% | 1 | 257 | 0.55 | 0.05 to 6.29 | 0.630 |
| Readmitted to hospital | 1.7% | 5 | 302 | 2.3% | 7 | 309 | 1.43 | 0.49 to 4.16 | 0.513 | 2.2% | 6 | 269 | .% | . | 261 | |||
| -POP other 5 | 1.0% | 3 | 302 | 1.6% | 5 | 309 | 1.5% | 4 | 269 | .% | . | 261 | ||||||
| -UI other 6 | 0.7% | 2 | 302 | 0.6% | 2 | 309 | 0.7% | 2 | 269 | .% | . | 261 | ||||||
| 6-Year outcomes | ||||||||||||||||||
| No. of women at 6 years | N = 272 | N = 277 | N = 238 | N = 250 | ||||||||||||||
| New prolapse operation 1 | 2.6% | 7 | 272 | 2.5% | 7 | 275 | 1.02 | 0.36 to 2.87 | 0.972 | 2.5% | 6 | 238 | 3.6% | 9 | 248 | 1.47 | 0.84 to 2.57 | 0.174 |
| Continence surgery | 1.9% | 5 | 270 | 0.4% | 1 | 276 | 0.24 | 0.02 to 2.43 | 0.227 | 2.1% | 5 | 236 | 0.4% | 1 | 249 | 0.18 | 0.02 to 1.80 | 0.144 |
| -SUI 2 | 0.7% | 2 | 270 | .% | . | 276 | 0.8% | 2 | 236 | 0.4% | 1 | 249 | ||||||
| -UI 3 | 1.1% | 3 | 270 | 0.4% | 1 | 276 | 1.3% | 3 | 236 | .% | . | 249 | ||||||
| Mesh removed 4 | 0.7% | 2 | 268 | 2.2% | 6 | 269 | 2.95 | 0.69 to 12.70 | 0.146 | 0.4% | 1 | 232 | 0.4% | 1 | 240 | 0.89 | 0.04 to 22.16 | 0.945 |
| Readmitted to hospital | 0.4% | 1 | 268 | 1.1% | 3 | 277 | 2.99 | 0.20 to 44.51 | 0.427 | 0.4% | 1 | 236 | 0.4% | 1 | 247 | 0.85 | 0.08 to 8.56 | 0.888 |
| -POP other 5 | 0.4% | 1 | 268 | 0.7% | 2 | 277 | 0.4% | 1 | 236 | .% | . | 247 | ||||||
| -UI other 6 | 0% | 0 | 268 | 0.4% | 1 | 277 | 0% | 0 | 236 | 0.4% | 1 | 247 | ||||||
Footnotes:
1. Repeat prolapse surgery: anterior or posterior repair, vaginal hysterectomy (if for prolapse), vault repair, sacrospinous fixation
2. Surgery for SUI: tape, midurethral sling, colposuspension, traditional sling, anterior repair (if for SUI), other
3. Other surgery for UI (any UI/urgency UI): Botox, sacral nerve stimulation (SNS), injectables, other
4. Any admission for mesh removal or mesh problems
5. Any other admission for prolapse-related problems: pessaries, granulation tissue procedures, Fenton’s procedure (for tight vagina), adhesion removal, other
6. Any other admission for urinary tract-related problems: UTIs, urinary retention, cystoscopy (if thought to be related to previous POP or continence surgery), catheter problems, other