Table.
Key Data Obtained During Rectal Distension
| Device | Procedure | Parameter | Normal subjects (n = 18) | FI patients (n = 26) | OD patients (n = 15) | Statistical significance between groups (1) or between devices (2) |
|---|---|---|---|---|---|---|
| 1 | Insertion | Percentage of subjects with contractions | 94% | 73% | 100% | Normal to FI: NS (borderline) Normal to OD: NS |
| Number of contractions (if contractions) | 1.8 ± 0.2, 2 (1–2) | 2.4 ± 0.4, 2 (1–3) | 3.7 ± 0.5, 4 (2–5) | Normal to FI: NS Normal to OD. P < .01 (U-value 47.5, z-score −2.66052. |
||
| Contractions per minute (if contractions) | 6.4 ± 0.3, 6 (6–7) | 6.4 ± 0.3, 6 (6–7) | 6.1 ± 0.3, 6 (6–7) | NS | ||
| Maximum contraction amplitude (if contractions) | 23.0 ± 2.7, 20 (16–28) | 27.4 ± 3.7, 21 (16–34) | 67.9 ± 10.5, 55 (37–91) | Normal to FI: NS Normal to OD. P < .0001 (U-value 16.5, z-score −3.9492. |
||
| Rear baseline pressure | 43.4 ± 4.5, 42 (33–50) | 38.0 ± 2.5, 40 (33–45) | 40.4 ± 2.5, 40 (36–48) | NS | ||
| Bend angle | 138.6 ± 7.0, 138 (117–159 | 139.0 ± 7.4, 150 (130–164) | 115.3 ± 8.7, 123 (89–137) | Normal to FI: NS Normal to OD. NS (borderline) |
||
| Distension | Urge volume | 36.3 ± 5.5, 28 (20–50) | 54.7 ± 4.1, 60 (40–70) | 51.3 ± 5.7, 40 (38–73) | Normal to FI. P < .05 (z-score 2.48253, Normal to OD: NS |
|
| Flow rate during filling | 0.71 ± 0.05, 0.66 (0.61–0.78) | 0.69 ± 0.05, 0.66 (0.57–0.79) | 0.83 ± 0.07, 0.74 (0.67–0.79) | NS | ||
| Percentage of subjects with contractions | 61% | 50% | 73% | Normal to FI: NS Normal to OD: NS |
||
| Number of contractions (if contractions) | 2.7 ± 0.5, 3 (1–4) | 3.6 ± 1.0, 2 (2–4) | 3.1 ± 0.3, 3 (2–4) | NS | ||
| Contractions per minute (if contractions) | 4.8 ± 0.4, 5 (4–6) | 6.4 ± 0.5, 6 (5–8) | 4.6 ± 0.4, 5 (4–6) | Normal to FI. P < .05 (U-value 35, z-score 2.08572). Normal to OD: NS |
||
| Maximum contraction amplitude (if contractions) | 20.2 ± 2.0, 20 (17–20) | 21.5 ± 1.9, 21 (17–25) | 44.9 ± 7.1, 40 (25–60) | Normal to FI: NS Normal to OD. P < .01 (U-value 18, z-score is −2.75793). |
||
| Rear baseline pressure | 38.5 ± 4.7, 31 (30–38) | 38.3 ± 2.1, 38 (32–47) | 41.3 ± 3.5, 38 (32–51) | NS | ||
| Bend angle | 135.6 ± 6.5, 145 (115–160) | 136.5 ± 7.2, 150 (123–159) | 126.4 ± 6.6, 122 (109–150) | NS. | ||
| 2 | Insertion | Normal subjects (n = 20) | ||||
| Percentage of subjects with contractions | 45% | P < .01 | ||||
| Number of contractions (if contractions) | 2.3 ± 0.5, 2 (2–2) | NS | ||||
| Contractions per minute (if contractions) | 5.4 ± 0.6, 6 (4–6) | NS | ||||
| Maximum contraction amplitude (if contractions) | 15.3 ± 1.4, 15 (12–19) | NS (borderline) | ||||
| Rear baseline pressure | 35.3 ± 2.7, 36 (26–46) | NS | ||||
| Bend angle | 109.3 ± 10.7, 126 (72–151) | NS (borderline) | ||||
| Distension | Urge volume | 77.5 ± 4.9, 83 (68–96) | P < .00001 (z-score 4.16603). | |||
| Flow rate during filling | 0.42 ± 0.02, 0.43 (0.36–0.46) | P < .00001 (z-score −4.54608). | ||||
| Percentage of subjects with contractions | 26% | NS (borderline) | ||||
| Number of contractions (if contraction) | 1.8 ± 0.3, 2 (1–2) | NS | ||||
| Contractions per minute (if contractions) | 3.2 ± 0.2, 3 (3–3) | P < .05 (U-value 8, z-score 2.46234). | ||||
| Maximum contraction amplitude (if contractions) | 18.0 ± 2.3, 18 (15–22) | NS | ||||
| Rear baseline pressure | 27.8 ± 2.1, 28 (21–37) | NS (borderline) | ||||
| Bend angle | 147.8 ± 6.7, 160 (141–166) | NS |
Device 1 is the wired Fecobionics device. Device 2 is the upgraded wireless device. Units are mL, cmH2O, and mL/sec for volume, pressure, and flow rate, respectively. The contraction analysis does not include values for subjects who did not show contractions. Mean and standard error of the mean as well as median and quartiles are provided. Statistical values listed for device 1 are for comparison between the normal and patient groups. Statistical values listed for device 2 are for comparison with device 1.