Table 2. Urogenital self-reported symptoms and clinician-observed signs (not associated with a laboratory-confirmed infection at the same visit) by randomisation group.
| Urogenital symptoms/signs recorded at baseline and ring removal visits1, 2, 3 | Baseline (N = 120) | Intermittent use of three rings (N = 60) | Continuous use of four rings (N = 60) | P-value4 |
|---|---|---|---|---|
| Total n (%) of randomised women with symptom(s) or sign(s) at the baseline visit | 18 (15) | NA | NA | |
| Total n (%) of women with incident symptom(s) or sign(s) during at least one ring removal visit | NA | 11/60 (18.3) | 17/60 (28.3) | 0.280 |
| Self-reported urinary symptoms | ||||
| Burning when passing urine | 2 (1.7) | 1/59 (1.7) | 4/59 (6.8) | 0.364 |
| Genital burning | 1 (0.8) | 3/59 (5.1) | 2/60 (3.3) | 0.679 |
| Frequent urination or urgent need | 0 (0.0) | 1/60 (1.7) | 0/60 (0.0) | 1.000 |
| Self-reported vaginal symptoms | ||||
| Genital itching | 2 (1.7) | 1/59 (1.7) | 2 /59 (3.4) | 1.000 |
| Lower abdominal pain | 3 (2.5) | 0/59 (0.0) | 6/58 (10.3) | 0.013 |
| Abnormal vaginal discharge | 1 (0.8) | 0/60 (0.0) | 0/59 (0.0) | |
| Pain during sex | 1 (0.8) | 0/59 (0.0) | 0/60 (0.0) | |
| Clinician-observed signs | ||||
| Vulvovaginal lesion/pustule | 0 (0.0) | 1/60 (1.7) | 1/60 (1.7) | 1.000 |
| Vaginal abnormal/unusual discharge | 11 (9.2) | 3/56 (5.4) | 1/53 (1.9) | 0.619 |
| Vaginal erythema or ulceration or laceration or abrasion or peeling or petechiae or ecchymosis or condylomata or oedema or cysts | 0 (0.0) | 1/60 (1.7) | 0/60 (0.0) | 1.000 |
| Vaginal vesicles | 0 (0.0) | 0/60 (0.0) | 1/60 (1.7) | 1.000 |
| Cervical abnormal/unusual discharge | 1 (0.8) | 2/60 (3.3) | 0/59 (0.0) | 0.496 |
| Cervical erythema, ulceration, laceration, abrasion, peeling, petechiae, ecchymosis, vesicles, condylomata, oedema, cysts | 1 (0.8) | 0/59 (0.0) | 1/60 (1.7) | 1.000 |
| Cervical os blood present | 0 (0.0) | 3/60 (5.0) | 10/60 (16.7) | 0.075 |
| Adnexal tenderness | 1 (0.8) | 0/60 (0.0) | 0/59 (0.0) |
NA = not applicable
1. Number of women with incident self-reported symptom or clinician-observed sign at one or more ring removal visits (%).
2. Women could report one or more symptoms, and study physicians could observe one or more signs, per ring removal visit.
3. Includes self-reported urogenital and vaginal symptoms.
4. Fisher’s exact test comparing intermittent and continuous users.