Clinical Evaluation of A Vaginal Bowel Control System for the Treatment of Fecal Incontinence

Richter H E1, Dunivan G C2, Brown H3, Andy U4, Dyer K5, Rardin C6, Muir T7, McNevin S8, Paquette I9, Gutman R10, Quiroz L11, Wu J12

Research Type

Clinical

Abstract Category

Anorectal / Bowel Dysfunction

Abstract 656
Bowel Dysfunction and Sexual Function
Scientific Podium Short Oral Session 34
Friday 31st August 2018
14:42 - 14:50
Hall D
Anal Incontinence Bowel Evacuation Dysfunction Female Quality of Life (QoL) Urgency, Fecal
1. University of Alabama at Birmingham, 2. University of New Mexico, 3. University of Wisconsin, 4. University of Pennsylvania, 5. Kaiser Permanente, San Diego, 6. Brown University, 7. Houston Methodist, 8. Providence Surgical Specialists, 9. Christ Hospital, 10. Medstar Washington Hospital Center, 11. University of Oklahoma, 12. University of North Carolina
Presenter
H

Holly E Richter

Links

Abstract

Hypothesis / aims of study
A previous proof of efficacy and safety study showed short-term benefit for a vaginal bowel control device for fecal incontinence (FI). This study evaluated the longer-term clinical effectiveness and impact on quality of life for women with FI.
Study design, materials and methods
Women with > 4 fecal incontinence episodes over 2 weeks were fit with the intra-vaginal device. In this responder analysis, subjects achieving a 50% reduction in FI episodes over a 2-week testing period were included in this trial. Treatment success was defined as achieving a >50% reduction of incontinent episodes, and was assessed at the primary endpoint of 3 months, and 6 and 12 months. The sample size for the study was selected to provide >90% power to detect a response rate of >40% of subjects achieving treatment success, and an exact binomial test was used to determine if this response rate was met at the 3, 6 and 12 month time points. Secondary outcomes included symptom impact measured by the Fecal Incontinence Quality of Life, symptom distress using the St Mark’s (Vaizey) questionnaire, Patient Global Impression of Improvement (PGI-I) and device satisfaction. Adverse events were collected. Intention-to-treat analysis included subjects who were successfully fit, responded to initial testing and entered treatment. Per protocol analysis included subjects with valid treatment diaries, no major protocol deviations and completion of the 3-month visit.
Results
73 subjects from eleven clinical sites were successfully fit and entered treatment. At 3 months, intention-to-treat success was, 72.6% (53/73, p<.0001) and per protocol success, 84.1% (53/63, p<.0001) (Table). Per-protocol success rate at 6 and 12 months was 89.5% (51/57), (95% CI, 78.5 – 96.0%) and 94.4% (51/54), (95% CI, 84.6 – 98.8%), respectively (Table).  ITT success rate at 6 and 12 months was 71.2% (52/73) (95% CI, 59.4 – 81.2%) and 69.9% (51/73) (95% CI, 58.0 – 80.1%), respectively.  Subjects counted in the ITT, but not in the PP, include those lost to follow-up, early study exits, and an incomplete study diary.  Among study completers, the average reduction in FI episodes improved over time from 77.3%, to 82.6%, to 85.4% at 3, 6, and 12 months, respectively. There was significant improvement in all Fecal Incontinence Quality of Life ( p<.0001) subscales (Figure). There was significant improvement of all time-points from baseline in the St Mark’s questionnaire (Table). Satisfaction was noted to be 90.3% (56/62), 89.3% (50/56) and 94.4% (51/54) at the 3, 6 and 12-month time-points, respectively; and 77.4% (48/62) vs 77.6% (45/58) vs 79.6% (43/54) of subjects were very much or much better on the PGI-I at 3, 6 and 12 months, respectively. There were no serious adverse events; the most common study-wide device-related adverse event including all enrolled subjects was vaginal abrasion (26/137 subjects, 19%), the majority of events (19/26, 63%) occurring during the fitting period.
Interpretation of results
For women with FI, the use of a transvaginal device with adjustable balloon resulted in a significant reduction in FI episodes and high treatment efficacy at 3 months, sustained to 12 months. Satisfaction with the device use was high and global impression of improvement of incontinence was found to be better or very much better in the majority of women. Adverse events are low and mainly noted in the fitting period.
Concluding message
A successfully fit vaginal bowel control device is an effective non-surgical treatment option for FI with effectiveness at 3, 6 and 12 months by objective and subjective measures.
Figure 1
Figure 2
Disclosures
<span class="text-strong">Funding</span> Pelvalon Research Grant <span class="text-strong">Clinical Trial</span> Yes <span class="text-strong">Registration Number</span> NCT02428595 <span class="text-strong">RCT</span> No <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics Committee</span> Institutional Review Board <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes