PMID- 23374680
OWN - NLM
STAT- MEDLINE
DCOM- 20140123
LR  - 20161125
IS  - 1463-1318 (Electronic)
IS  - 1462-8910 (Linking)
VI  - 15
IP  - 5
DP  - 2013 May
TI  - Long-term efficacy of dextranomer in stabilized hyaluronic acid (NASHA/Dx) for 
      treatment of faecal incontinence.
PG  - 569-74
LID - 10.1111/codi.12155 [doi]
AB  - AIM: Randomized, controlled trials have demonstrated the efficacy and safety of 
      injectable bulking agents for the treatment of faecal incontinence (FI), although 
      the long-term outcome has not been assessed. NASHA/Dx gel, a biocompatible, 
      nonallergenic bulking agent consisting of nonanimal stabilized hyaluronic acid 
      and dextranomer microspheres, has demonstrated efficacy and safety for up to 12 
      months after treatment. The objective of this study was to evaluate the long-term 
      efficacy and safety of NASHA/Dx, assessed 24 months after treatment. METHOD: This 
      study was a 24-month follow-up assessment of patients treated with NASHA/Dx under 
      open-label conditions. Data on FI episodes and quality of life measures were 
      collected from diaries over the 28-day period immediately preceding the 24-month 
      assessment. Adverse events were collected. RESULTS: Eighty-three of 115 patients 
      completed the 24-month follow-up assessment. At 24 months, 62.7% of patients were 
      considered responders and experienced a >/= 50% reduction in the total number of FI 
      episodes. The median number of FI episodes declined by 68.8% (P < 0.001). 
      Episodes of both solid and liquid stool incontinence decreased. The mean number 
      of incontinence-free days increased from 14.6 at baseline to 21.7 at 24 months (P 
      < 0.001). Incontinence scores and FI quality of life scores also showed 
      significant improvements. The most common adverse events (AEs) were proctalgia 
      (13.3%) and pyrexia (9.6%). The majority of AEs were mild to moderate, 
      self-limited and resolved within 1 month of the injection. CONCLUSION: NASHA/Dx 
      is safe, effective and durable over a 24-month period with a majority of patients 
      experiencing significant improvement in multiple symptoms associated with FI.
CI  - (c) 2013 The Authors. Colorectal Disease (c) 2013 The Association of Coloproctology 
      of Great Britain and Ireland.
FAU - La Torre, F
AU  - La Torre F
AD  - Department of Colorectal and Pelvic Surgery, Rome University, Rome, Italy. 
      filippo.latorre@uniroma1.it
FAU - de la Portilla, F
AU  - de la Portilla F
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Colorectal Dis
JT  - Colorectal disease : the official journal of the Association of Coloproctology of 
      Great Britain and Ireland
JID - 100883611
RN  - 0 (Dextrans)
RN  - 0 (Gastrointestinal Agents)
RN  - 0 (dextranomer-hyaluronic acid copolymer)
RN  - 9004-61-9 (Hyaluronic Acid)
SB  - IM
MH  - Aged
MH  - Dextrans/adverse effects/*therapeutic use
MH  - Fecal Incontinence/*drug therapy
MH  - Female
MH  - Fever/chemically induced
MH  - Follow-Up Studies
MH  - Gastrointestinal Agents/adverse effects/*therapeutic use
MH  - Humans
MH  - Hyaluronic Acid/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Pain/chemically induced
MH  - Quality of Life
MH  - Rectum
MH  - Severity of Illness Index
MH  - Time Factors
EDAT- 2013/02/05 06:00
MHDA- 2014/01/24 06:00
CRDT- 2013/02/05 06:00
PHST- 2012/07/11 00:00 [received]
PHST- 2012/12/15 00:00 [accepted]
PHST- 2013/02/05 06:00 [entrez]
PHST- 2013/02/05 06:00 [pubmed]
PHST- 2014/01/24 06:00 [medline]
AID - 10.1111/codi.12155 [doi]
PST - ppublish
SO  - Colorectal Dis. 2013 May;15(5):569-74. doi: 10.1111/codi.12155.