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Treatment Anal incontinence

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  • Treatment Anal incontinence

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        RDD 0315, alternatively named Oxymetazoline is a topical (intra anal) gel that increases resting anal sphincter pressure.

        Abstract ID 1549

        A Double Blind Crossover Placebo Controlled Study, to Examine the Effect of a Topical
        Alpha Agonist on Fecal Incontinence in Spinal Cord Injury Patients

        The number of SCI patients in the US is estimated at between 240,000 to 337,000 persons (UAB/ National SCI Database Feb 2015). Fecal Incontinence (FI) is a devastating
        complication occurring in 75% of patients following spinal cord injury. FI accounts for not only a drastic reduction in quality of life but also is responsible for mortality,
        secondary to septicemia, resulting from stool contamination of decubitus ulceration. Patients with SCI (no less than 3 months and up to 5 years post injury) and FI
        (at least 4 episodes/week) were enrolled into a double blind, placebo controlled crossover study in which each patient was treated with RDD 0315 and placebo.
        Prior to randomization, all patients underwent a one day open label manometry assessment of resting anal pressure response to RDD 0315.

        Primary Endpoint: The number of fecal incontinence episodes in the eight (8) and twelve (12) hours post drug administration, tested using a two group t test (Crossover ANOVA)
        with a 0.05 two sided significance level. 19 patients were enrolled, 16 were males, average age was 42+9 years, and 9 had complete spinal cord injury (grade A in ASIA scale).
        Baseline resting anal pressure was reduced in all patients (33.8+17.8 mmHg) and increased by 15% in response to RDD 0315. Analysis of change revealed a mean reduction
        of 6.95 ?13.64,( p = 0.021) in the number of unwanted bowel movements during the 8 hours post active treatment as compared to placebo (down from 25 ?27.47, to 18.05 ?19.99).

        A similar drug was tested in 1999, with similar results. Wonder why it didn't go where?

        Br J Surg. 1999 Feb;86(2):267-70.

        Topical phenylephrine increases anal sphincter resting pressure.

        Carapeti EA1, Kamm MA, Evans BK, Phillips RK.

        Phenylephrine is an alpha1-adrenergic agonist which causes contraction of human internal anal sphincter muscle in vitro. Its intra-arterial administration in animals has been shown to increase resting sphincter pressure in vivo. In this study the effect of topical application of phenylephrine on resting anal pressure in healthy human volunteers was investigated.

        METHODS: Twelve healthy volunteers had measurements of maximum resting sphincter pressure (MRP) and anodermal blood flow taken before and after topical application of increasing concentrations of phenylephrine gel to the anus. To determine the duration of effect of the agent, readings were taken throughout the day after a single application.

        RESULTS:There was a dose-dependent rise in the resting anal sphincter pressure, with a small 8 per cent rise after 5 per cent phenylephrine (P = 0.012) and a larger 33 per cent rise with 10 per cent phenylephrine (mean(s.d.) MRP 85(12) cmH2O before versus 127(12) cmH2O after treatment, P < 0.0001). Thereafter no additional response was noted with higher concentrations of phenylephrine. The median duration of action of a single application of 10 per cent phenylephrine was 7 (range from 6 to more than 8) h.

        CONCLUSION:Topical application of 10 per cent phenylephrine gel to the anus produces a significant rise in the resting anal sphincter pressure in healthy human volunteers. This represents a potential novel therapeutic approach to the treatment of passive faecal incontinence associated with a low resting anal sphincter pressure.