Solesta (hyaluronic acid/dextranomer) / Bausch Health - LARVOL DELTA

Optimizing Clinical Outcomes: The Efficacy of Biofeedback Therapy (BFT) in Managing Resistant Fecal Incontinence (ACG 2024) - "A total of 513 completed ARM within the study period; 111 (22%) patients were referred for FI. Of this subgroup, 25 were initially treated with conservative measures, but only 6 (24%) reported benefit, while 19 (76%) reported no benefit (p < 0.0001). Overall, 46 (41%) patients were referred to BFT and of those, 29 (63%) completed the BFT therapy sessions."

Clinical • Clinical data • CNS Disorders

Ultrasound-guided fine-needle aspiration of a rectal submucosal nodule. (PubMed, Diagn Cytopathol) - "This case illustrates the pathognomonic features of Solesta-induced rectal nodule and underscores the importance of detailed history as well as inclusion of iatrogenic diseases in the differential to prevent erroneous diagnosis and management. Potential pitfalls in cytopathological diagnosis are discussed."

Journal • Oncology

A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence (clinicaltrials.gov) - P=N/A; N=206; Completed; Sponsor: Bausch Health Americas, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion

Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI) (clinicaltrials.gov) - P=N/A; N=277; Completed; Sponsor: Bausch Health Americas, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion