Pilot study of two new injectable bulking agents for the treatment of faecal incontinence. Elastomer implants in faecal incontinence: a blind, randomized placebo-controlled study. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial.
The use of injectable bulking agents for passive faecal incontinence appears to provide reasonable short-term results. However experience with different agents is limited. We report on the outcome of injections with new bulking agents.
                Each patient received injections of either Bulkamid (hydrogel cross-linked with polyacrylamide) or Permacol (porcine dermal collagen). Assessment included clinical evaluation, anorectal physiological testing, endoanal ultrasonography and questionnaires including the St Mark's Incontinence Score, one week bowel diary card, the Faecal Incontinence Quality of Life Scale and the Short Form-36 (SF-36) health survey. Follow up was at 6 weeks and 6 months, with a further telephone review at a median of 19 months (range 14-22).
                Ten patients (nine female), median age 68 years (range 45-79), were enrolled. St Mark's incontinence score (0 = best, 24 = worst) was 15 (range 11-24) at baseline, 12.5 (range 3-18) at 6 weeks and 14 (range 6-22) at 6 months. A 1-week bowel diary and SF-36 forms also showed temporary improvement but this was not sustained beyond 6 weeks.
                Bulkamid and Permacol injections did not have a major effect on faecal incontinence. To test efficacy and safety of polydimethylsiloxane elastomer implants, a silicone biomaterial, in patients with severe faecal incontinence related to an impaired internal anal sphincter.
                Subjects were randomized to receive three injections of 2.5 mL of either physiological saline or polydimethylsiloxane elastomer. After local anaesthesia, an 18 gauge, 2.5-in needle was inserted through the perianal skin and laid down into the intersphincteric space. Treatment (saline or polydimethylsiloxane elastomer) was administered by means of a ratchet gun. Three injections of 2.5 mL each were performed in the area of the internal anal sphincter at 3, 7 and 11 o'clock positions. Main end point was the percentage of subjects in each treatment arm experiencing a successful treatment, defined as a Cleveland Clinic Florida-Faecal Incontinence score <8, 3 months after treatment. Secondary end points were quality of life scores, weekly number of faecal incontinence episodes, subject acceptance and adverse events rate. Both patients and end point assessments were blinded to treatment. Results: 44 women (64.3 +/- 9 years) with a baseline Cleveland Clinic Florida-Faecal Incontinence score > or =8 were enrolled prospectively; 22 received polydimethylsiloxane elastomer and 22 saline treatment. Treatment was well tolerated. At 3 months, the percentage of subjects experiencing a successful treatment was not different between polydimethylsiloxane elastomer and saline groups (23% vs. 27%, respectively, P = 0.73). Moreover, Cleveland Clinic Florida-Faecal Incontinence score was not significantly different between polydimethylsiloxane elastomer and saline groups (11.7 +/- 4.7 vs. 11.4 +/- 4.5, respectively, P = 0.79).
                Polydimethylsiloxane elastomer implants cannot be recommended for treatment of severe faecal incontinence related to impaired internal anal sphincter. 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.
                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.
                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).
                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.
                Q-Med AB.
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One large randomised controlled trial has shown that this form of treatment using dextranomer in stabilised hyaluronic acid (NASHA Dx) improves continence for a little over half of patients in the short term. However, the number of identified trials was limited and most had methodological weaknesses.