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Finding
Finding
adverse
The most common adverse event was vaginal wall injury, with most adverse events (90/134, 67%) occurring during the fitting period rather than the treatment period. No serious device-related adverse events occurred, 94% of vaginal wall injuries during treatment were mild, and none caused study discontinuation.
| Effect size | 28/73 (38%) experienced mild or moderate device-related AEs during treatment period |
| Follow-up | 12 months |
| Comparator | No comparator (single-arm safety assessment) |
| Effect summary | adverse; 28/73 (38%) experienced mild or moderate device-related AEs during treatment period |
| Adverse events | vaginal wall injury 67%, mild or moderate AEs 38%, 0 serious AEs |
Connected entities
Interventions
Conditions
Outcomes
Populations
Source
PMC6659396
A 12-Month Clinical Durability of Effectiveness and Safety Evaluation of a Vaginal Bowel Control System for the Nonsurgical Treatment of Fecal Incontinence