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Finding improvement
The vaginal bowel control system achieved a 72.6% success rate (50% or greater reduction in FI episodes) at 3 months in the ITT population, with success rates sustained at 6 and 12 months and reaching 90-94% in the per-protocol population.
Effect size72.6% success rate (ITT) at 3 months
CI95% CI, 61%-82%
Follow-up12 months
ComparatorBaseline FI episode count (pre-treatment, 2-week bowel diary); null hypothesis threshold of 40% success rate
Effect summaryimprovement; 72.6% success rate (ITT) at 3 months; CI: 95% CI, 61%-82%

Connected entities

Interventions
Vaginal bowel control system
Conditions
Fecal Incontinence
Outcomes
Reduction in number of falls

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
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