Table 1.
Study patient characteristics in the TrimoSan© gel and no TrimoSan© gel groups.
| TrimoSan© (n (%) or mean ± standard deviation* or median (variance)**) n=92 | No TrimoSan© (n (%) or mean ± standard deviation*or median (variance)**) n=92 | Total Patients n=184 | |
|---|---|---|---|
| Age (years)* | 58 ± 15 | 60 ± 17 | 59 ± 16 |
| Body Mass Index (kg/m2)* | 29 ± 7.6 | 28 ± 7.4 | 28 ± 7.5 |
| Race | |||
| Caucasian | 56 (61) | 48 (52) | 105 (57) |
| African American | 6 (7) | 13 (14) | 19 (10) |
| Hispanic | 23 (25) | 20 (22) | 43 (23) |
| Asian | 1 (1) | 3 (3) | 4 (2) |
| Other | 5 (5) | 8 (9) | 13 (7) |
| Parity** | 3 (2.6) | ||
| Vaginal deliveries** | 2 (2.4) | ||
| Indication for pessary use | |||
| Prolapse | 41 (44) | 45 (49) | 86 (47) |
| Urinary incontinence | 35 (38) | 30 (33) | 65 (35) |
| Both prolapse and urinary incontinence | 13 (14) | 10 (11) | 23 (13) |
| Smoking | |||
| Current | 8 (9) | 6 (7) | 14 (8) |
| Past | 26 (28) | 28 (30) | 54 (29) |
| Charleston Comorbidity Index* | 0.77 ± 1.1 | 0.89 ± 1.8 | 0.82 ± 1.5 |
| Insurance type | |||
| Private | 36 (39) | 38 (41) | 74 (40) |
| Public | 27 (29) | 34 (37) | 61 (33) |
| None | 7 (8) | 6 (7) | 13 (7) |
| Education Level | |||
| Graduate | 25 (27) | 28 (30) | 53 (29) |
| College | 37 (40) | 29 (32) | 66 (36) |
| High school | 20 (22) | 28 (30) | 48 (26) |
| Less than high school diploma | 3 (3) | 4 (4) | 7 (4) |
| Job Activity Level | |||
| Sedentary work | 16 (17) | 16 (17) | 32 (17) |
| Homemaker | 18 (20) | 18 (20) | 36 (20) |
| Light labor | 20 (22) | 26 (28) | 46 (25) |
| Heavy labor | 8 (9) | 5 (5) | 13 (7) |
| Unemployed or retired | 26 (28) | 19 (21) | 45 (24) |
| Prior pelvic surgery | 41 (49) | 39 (42) | 80 (43) |
| Prior pessary use | 9 (10) | 4 (4) | 13 (7) |
| Vaginal Infection History | |||
| Vaginal infection last 12 months | 10 (11) | 7 (8) | 17 (9) |
| HT | |||
| Using hormone therapy (HT) at time of recruitment | 22 (24) | 24 (26) | 46 (25) |
| Vaginal HT at time of recruitment | 19 (21) | 19 (21) | 38 (21) |
| HT prescribed at time of recruitment | 13 (14) | 14 (15) | 27 (15) |
| Pessary Refitting | |||
| Required refitting at 2 weeks | 13 (14) | 12 (13) | 25 (14) |
| Required refitting at 3 months | 15 (16) | 12 (13) | 27 (15) |
| BV Measures | |||
| BV by Nugent's criteria at baseline | 23 (25) | 15 (16) | 38 (21) |
| Total Nugent's score at baseline* | 4.5 ± 2.0 | 4.8 ± 2.4 | 4.6 ± 2.2 |
| BV by BV® BLUE at baseline | 1 (1) | 2 (2) | 3 (2) |