Background Successful development of a novel medical device requires an early understanding of anatomical feasibility and acceptance by both patient and clinician. In the absence of acceptable artificial anatomical test models, short-term evaluation with controlled observation in a small number of patients can be pursued to demonstrate initial feasibility. The vaginal bowel control (VBC) system, a non-surgical device for faecal incontinence (FI), is difficult to evaluate in artificial models. In-person usage was required to understand the potential for a vaginal insert to provide comfortable, dynamic rectal occlusion.
Methods This prospective, open-label study was conducted at a single urogynaecology practice at an academic medical centre with 13 female subjects ≥18 years with self-reported FI. The VBC therapy consists of a vaginal insert and pressure-regulated pump. The vaginal insert includes a balloon that, when inflated, creates an occlusion of the rectum. Subjects’ FI symptoms were collected in a baseline questionnaire. The investigator fitted subjects with multiple sizes of VBC inserts and evaluated the fit, position and degree of rectal occlusion. Subject comfort levels were assessed throughout the fitting process with a verbal response and on a subject questionnaire using a 10-point scale (1=no discomfort, 10=extremely uncomfortable). The insert was returned at the end of the study visit.
Results The majority of the rectum was occluded in 77% of patients. Furthermore, comfort scores during insertion (2.1±2.0), inflation (3.3±2.6) and ambulation (2.6±2.0) states indicated minor discomfort with 42% of women indicating no discomfort in any states. No adverse events were reported.
Conclusions Pilot evaluation of an early VBC system design and its delivery during a single study visit provided evidence for effectiveness, patient comfort and ease of use of a novel VBC for FI in women. This first-in-woman study confirmed feasibility of VBC and informed continued product development and subsequent clinical research.
- feasibility study
- fecal incontinence
- vaginal bowel control system
- accidental bowel leakage
- fecal urgency
- vaginal insert
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Contributors ERS planned the study in conjunction with the sponsor, Pelvalon, conducted the study, created the report and is responsible for the overall content as guarantor.
Funding This research was funded by the Wallace H. Coulter Translational Research Grant.
Competing interests ERS has received stock options in Pelvalon.
Ethics approval Stanford University Institutional Review Board (IRB) for Human Subjects Research.
Provenance and peer review Not commissioned; externally peer reviewed.
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