Table 1.
Patient characteristics (per protocol analysis)
| ACTICORE group | Control group | ||
|---|---|---|---|
| Basic data | n=10 | n=14 | P a |
| Age | 42.5 [35.5–54.5] | 41.0 [35.5–48.5] | >0.9 |
| Sex | |||
| Female | 9 (90%) | 13 (92.9%) | >0.9 |
| Male | 1 (10%) | 1 (7.1%) | |
| ASA Score | |||
| I | 6 (60%) | 9 (64.3%) | 0.6 |
| II | 3 (30%) | 5 (35.7%) | |
| III | 1 (10%) | 0 ( 0%) | |
| BMI | |||
| kg/m2 | 24.6 [23.0–26.8] | 23.6 [22.3–24.8] | 0.3 |
| Cause of UI | |||
| Stress incontinence | 8 (80.0%) | 12 (85.7%) | 0.7 |
| Urge incontinence | 2 (20.0%) | 1 (7.1%) | |
| Mixed incontinence | 0 (0%) | 1 (7.1%) | |
| Amount of transvaginal births | |||
| 0 | 3.0 (30.0%) | 5 (35.7%) | 0.7 |
| 1 | 5.0 (50.0%) | 4 (28.6%) | |
| 2 | 2.0 (20.0%) | 3 (21.4%) | |
| 3 | 0 ( 0%) | 2 (14.3%) | |
| Perineal tears | |||
| 0 | 6 (60.0%) | 5 (35.7%) | 0.5 |
| 1 | 4 (40.0%) | 8 (57.1%) | |
| 3 | 0 ( 0%) | 1 (7.1%) | |
| Perineal cut | 4 (40.0%) | 2 (14.3%) | 0.2 |
| Wearing of incontinence inserts | 5 (50.0%) | 6 (42.9%) | >0.9 |
| Conduct of heavy physical work | 1 (10.0%) | 2 (14.3%) | >0.9 |
| No feeling of prolapse | 8 (80.0%) | 8 (57.1%) | 0.9 |
| Negative impact of UI on sexuality (NAS) | 10 (2.0–20.0) | 32.1 (0.0–60.0) | 0.6 |
| Nycturia | |||
| No suffering of nycturia | 4 (40.0%) | 4 (28.6%) | >0.9 |
| 1 UPN | 4 (40.0%) | 6 (42.9%) | |
| 1–2 UPN | 1 (10.0%) | 2 (14.3%) | |
| 2–3 UPN | 1 (10.0%) | 1 (7.1%) | |
| 3 UPN | 0 ( 0%) | 1 (7.1%) | |
Continuous measurements are presented as mean (SD), median [IQR]; ASA, American Society of Anaesthesiologists physical status classification; NAS, numeric analog scale; UI, urinary incontinence; UPN, urination per night.
a
Fisher’s exact test; Wilcoxon Mann–Whitney test; χ 2test for independence.
Table 1 Univariate analysis of patients who met the primary endpoint (per protocol analysis).