uu.seUppsala University Publications
Change search
ReferencesLink to record
Permanent link

Direct link
Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Colorectal Surgery.
Show others and affiliations
2011 (English)In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 377, no 9770, 997-1003 p.Article in journal (Refereed) Published
Abstract [en]

Background: Injection of a bulking agent in the anal canal is an increasingly used treatment for faecal incontinence, but efficacy has not been shown in a controlled trial. We aimed to assess the efficacy of injection of dextranomer in stabilised hyaluronic acid (NASHA Dx) for treatment of faecal incontinence. Methods In this randomised, double-blind, sham-controlled trial, patients aged 18-75 years from centres in USA and Europe were randomly assigned (2:1) to receive either transanal submucosal injections of NASHA Dx or sham injections. Randomisation was stratified by sex and region in blocks of six, and managed with a computer generated, real-time, web-based system. Patients and investigators were masked to assignment for 6 months when the effect on severity of faecal incontinence and quality of life was assessed with a 2-week diary and clinical assessments. The primary endpoint was response to treatment based on the number of incontinence episodes. A response to treatment was defined as a reduction in number of episodes by 50% or more. Patients in the active treatment group are still being followed up. This trial was registered with ClinicalTrials.gov, number NCT00605826. Findings 278 patients were screened for inclusion, of whom 206 were randomised assigned to receive NASHA Dx (n=136) or sham treatment (n=70). 71 patients who received NASHA Dx (52%) had a 50% or more reduction in the number of incontinence episode, compared with 22 patients who received sham treatment (31%; odds ratio 2.36, 95% CI 1.24-4.47, p=0.0089). We recorded 128 treatment-related adverse events, of which two were serious (1 rectal abscess and 1 prostatic abscess). Interpretation Anal injection of NASHA Dx is an effective treatment for faecal incontinence. A refinement of selection criteria for patients, optimum injected dose, ideal site of injection, and long-term results might further increase the acceptance of this minimally invasive treatment.

Place, publisher, year, edition, pages
2011. Vol. 377, no 9770, 997-1003 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-151657DOI: 10.1016/S0140-6736(10)62297-0ISI: 000288775800028PubMedID: 21420555OAI: oai:DiVA.org:uu-151657DiVA: diva2:410971
Available from: 2011-04-15 Created: 2011-04-15 Last updated: 2012-01-10Bibliographically approved

Open Access in DiVA

No full text

Other links

Publisher's full textPubMed

Search in DiVA

By author/editor
Graf, Wilhelm
By organisation
Colorectal Surgery
In the same journal
The Lancet
Medical and Health Sciences

Search outside of DiVA

GoogleGoogle Scholar
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 208 hits
ReferencesLink to record
Permanent link

Direct link