ArticleGastroenterology research and practice2010
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.
Article in Gastroenterology research and practice, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.
- Perianal injectable bulking agents as treatment for faecal incontinence in adults.The Cochrane database of systematic reviews · 2013Pooled it
- Identifying factors associated with clinical success in patients treated with NASHA(®)/Dx injection for fecal incontinence.Clinical and experimental gastroenterology · 2016Article
- Clinical Challenges of Fecal Incontinence in the Elderly.Current treatment options in gastroenterology · 2015Article
- Validity of the ≥50% Response Threshold in Treatment With NASHA/Dx Injection Therapy for Fecal Incontinence.Clinical and translational gastroenterology · 2015Article
- Long-term evaluation of bulking agents for the treatment of fecal incontinence: clinical outcomes and ultrasound evidence.Techniques in coloproctology · 2015Article
- Current and emerging treatment options for fecal incontinence.Journal of clinical gastroenterology · 2014Review
- Current status: new technologies for the treatment of patients with fecal incontinence.Surgical endoscopy · 2014Review
- Endoscopic and imaging appearance after injection of an ano-rectal bulking agent.World journal of gastrointestinal endoscopy · 2014Article
- Current management of fecal incontinence: choosing amongst treatment options to optimize outcomes.World journal of gastroenterology · 2013Review
- Dextranomer in stabilized sodium hyaluronate (Solesta®): in adults with faecal incontinence.Drugs · 2012Review
- Novel treatment of fecal incontinence with an injectable biocompatible tissue bulking agent.Gastroenterology & hepatology · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 < .001) 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.
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.