3.6. Analysis.
Comparison 3 Faecal incontinence: crossover trials, Outcome 6 Cleveland Clinic Incontinence Score.
| Cleveland Clinic Incontinence Score | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Study | Group | Measure | Patients | Baseline | Three months | 'Off' period | 'On' period | Change (%) | Follow‐up | Notes |
| Kahlke 2015# | Mean (SD) | 14 | 16 (4.6) | 14.6 (4.6) | 8.7 (3.6) | ‐5.9 (‐40%) | 6.4 (3.3) | p<0.05 | ||
| Kahlke 2015# | ||||||||||
| Kahlke 2015# | ||||||||||
| Leroi 2005# | Whole group | Median (range) | Baseline: 23 3 months: 16 'Off' period: 15 'On' period: 17 | 16 (8 to 20) | 9 (0 to 19) | 10.5 (4 to 17) | 8.5 (3 to 18) | ‐2 (‐19%) | Not reported for whole group | 1. Cleveland Clinic scores are reported for whole group. 2. The score ranges from 0 (normal continence) to 20 (maximum incontinence) |
| Leroi 2005# | Group of 19 who chose 'on' following the crossover period | Median (range) | Baseline: 18 3 months: 13 'Off' period: 12 'On' period: 14 Follow‐up: 18 | 16 (8 to 20) | 8 (0 to 15) | 10 (4 to 17) | 8 (3 to 15) | ‐2 (‐20%) | 10 (3 to 17) | 1. P < 0.05: 3 months, 'off' period, 'on' period, follow‐up versus baseline. |
| Leroi 2005# | Group of 5 who chose 'off' following the crossover period | Median (range) | Baseline: 5 3 months: 3 'Off' period: 3 'On' period: 3 Follow‐up: 3 | 16 (12 to 20) | 14 (9 to 19) | 15 (11 to 15) | 15 (14 to 18) | 0 | 13 (11 to 18) | |
| Thin 2015 | PTNS group | Mean±SD | 16 | 15.1 ± 2.7 | 11.7 ± 4.4 | ‐3 (‐ 20%) | 12.1 ± 5.2 | Follow‐up was at 6 months. % change is reported as the difference between baseline and at 6 months. | ||
| Thin 2015 | SNS group | Mean±SD | 15 | 16.3 ± 3.3 | 10.0 ± 5.3 | ‐7.2(‐44%) | 9.1 ± 5.4 | Follow‐up was at 6 months. % change is reported as the difference between baseline and at 6 months. | ||
| Thin 2015 | ||||||||||
| Tjandra 2008 | Control group | Mean±SD | 60 | 15.2±1.6 | 12.1±2.1 | 14.1+1.9 | ‐1.1 (‐7%) | 14.1±1.9 | p > 0.05 at 3 months and 12 months compared with baseline. Follow‐up was at 12 months. % change is reported as the difference between baseline and at 12 months. | |
| Tjandra 2008 | SNS group | Mean±SD | 53 | 16±1.3 | 1.1±1 | 1.2+1.8 | ‐14.8 (‐93%) | 1.2±1.8 | P < 0.0001 at all time points compared with baseline. Follow‐up was at 12 months. % change is reported as the difference between baseline and at 12 months. | |
| Tjandra 2008 | ||||||||||