An Open-Label, Noncomparative, Multicenter Study to Evaluate Efficacy and Safety of NASHA-Dx Gel as a Bulking Agent for the Treatment of Fecal IncontinenceReport as inadecuate

An Open-Label, Noncomparative, Multicenter Study to Evaluate Efficacy and Safety of NASHA-Dx Gel as a Bulking Agent for the Treatment of Fecal Incontinence - Download this document for free, or read online. Document in PDF available to download.

Gastroenterology Research and PracticeVolume 2010 2010, Article ID 467136, 10 pages

Research Article

Università degli Studi di Padova Hospital Clinica Chirurgica, Via Giustiniani 2, 35128 Padova, Italy

Proktologische Praxis Kiel, Beselerallee 67, 24105 Kiel, Germany

Coloproctology Section, Department of Surgery, Virgen del Rocio University Hospital, Avenida Manuel Siurot s-n, 41013 .Seville, Spain

St. Paul-s Hospital, C313-1081 Burrard Street, Vancouver, BC, Canada V6Z 1Y6

Coloproctological Unit of Bari Policinico di Bari Piazza, University of Bari, Giulio Cesare 11, 70124 Bari, Italy

Clinique Chirurgicale, chu-Hôtel-Dieu, Institut des Maladies de l-Appareil Digestif, 1 Place Alexis Ricordeau, 44093 Nantes Cedex, France

Received 12 June 2010; Revised 1 October 2010; Accepted 4 November 2010

Academic Editor: Y. Yamaoka

Copyright © 2010 Giuseppe Dodi et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Fecal incontinence FI is the involuntary loss of rectal contents through the anal canal. Reports of its prevalence vary from 1–21%. Studies, have demonstrated a positive effect on FI symptoms with injectable bulking agents. This study evaluated the safety and efficacy of NASHA-Dx gel in the treatment of FI. One hundred fifteen eligible patients suffering from FI received 4 injections of 1 mL NASHA-Dx gel. Primary efficacy was based on data from 86 patients that completed the study. This study demonstrated a ≥50% reduction from baseline in the number of FI episodes in 57.1% of patients at 6 months, and 64.0% at 12 months. Significant improvements 𝑃 < . 0 0 1 were also noted in total number of both solid and loose FI episodes, FI free days, CCFIS, and FIQL scores in all 4 domains. The majority of the treatment related AEs 94.9% were mild or moderate intensity, and 98.7% of AEs resolved spontaneously, or following treatment, without sequelae. Results of this study indicate NASHA-Dx gel was efficacious in the treatment of FI. Treatment effect was significant both in reduction of number of FI episodes and disease specific quality of life at 6 months and lasted up to 12 months after treatment.

Author: Giuseppe Dodi, Johannes Jongen, Fernando de la Portilla, Manoj Raval, Donato F. Altomare, and Paul-Antoine Lehur



Related documents