Dis Colon Rectum. 2022 Jan 4. doi: 10.1097/DCR.0000000000002348. Online ahead of print.

Lieschen H Quiroz ¹, Domingo E Galliano Jr, Giovanna da Silva, Joseph C Carmichael, Li-Chen Pan, Emilie R Bromley, Jordan Hinahara, Thomas F Goss

Author information

¹Female Pelvic Medicine and Reconstructive Surgery, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma University Surgical Associates, Port Charlotte, Florida Cleveland Clinic Florida-Weston, Weston, Florida UCI Health, Orange County, California Boston Healthcare Associates, Boston, Massachusetts.

Abstract

Background: Fecal incontinence affects 7-12% of the US adult population, causing social, financial, and quality of life burdens.

Objective: The primary aims of this study were to evaluate the efficacy and safety of non-animal stabilized hyaluronic acid/dextranomer through 36 months as a condition of postmarket approval application.

Design: This was a prospective, single-arm, multicenter, observational FDA-mandated post-approval clinical study.

Settings: This study was designed by participating investigators, the FDA, and the study sponsor who managed the data collection.

Patients: A total of 283 subjects who previously failed conservative therapy were enrolled in a prospective, single-arm study across 18 US sites (NCT01647906).

Interventions: Participants received 1-2 non-animal stabilized hyaluronic acid/dextranomer treatments. The first treatment occurred within 30 days of baseline, while a second treatment was administered 1-3 months after initial treatment if determined necessary by physician. Subjects were followed through 7 visits over 36-months after last treatment.

Main outcome measures: Efficacy (as specified by FDA) was measured as a fecal incontinence reintervention rate of <50% at 36 months. Reintervention included non-animal stabilized hyaluronic acid/dextranomer retreatment, surgical interventions and physical therapy. Safety was measured by device-related adverse events. Secondary endpoints included Fecal Incontinence Quality of Life Scale and Cleveland Clinic Florida Fecal Incontinence Score.

Results: Using a Bayesian estimate, the reintervention rate of the intention to treat population (n=283) was 18.9% (95% CI:14.0%, 24.4%) at 36 months. At 36 months, the reintervention rate for subjects with complete data (n = 192) was 20.8% (95% CI: 15.1%, 26.6%). Significant improvement (p < 0.0001) was noted across Cleveland Clinic Florida Fecal Incontinence Score and Fecal Incontinence Quality of Life subscales at 36 months. 92 device-related adverse events were reported by 15.2% of enrolled patients; most were gastrointestinal disorders and resolved quickly. There were no serious adverse events.

Limitations: Limitations include a 32% attrition rate and homogeneous patient population (91.8% white, 85.5% female), possibly limiting generalizability.

Conclusion: Non-animal stabilized hyaluronic acid/dextranomer demonstrated clinically significant, sustained improvement in symptoms and quality of life for fecal incontinence patients, without the occurrence of any serious adverse events. See Video Abstract at http://links.lww.com/DCR/B890.

Registration: ClinicalTrials.gov number NCT01647906.