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    SUI: Phase III data offer lessons for trials evaluating cell therapy

     

    To identify alternate endpoints, Dr. Kaufman and colleagues looked at the correlation of IEF reduction and scores on Incontinence Quality of Life (IQOL) questionnaires. They found that patients who had a ≥50% IEF reduction had greater IQOL score improvement versus patients with <50% IEF reduction. Patients with ≥75% IEF reduction displayed even greater IQOL improvement.

    Moreover, a potential treatment effect was detected for the entire patient cohort using IEF endpoints, and this was pronounced for a subgroup of 17 patients (11 AMDC, six placebo) who had recurrent or persistent SUI after incontinence surgery, according to investigators.

    Based on this experience, investigators have revised clinical endpoints for current and future trials to encompass ≥50% or ≥75% diary-reported incontinence episodes or less than one stress leak during the 3-day diary period.

    Also see: Practice ‘report card’ tracks performance

    Perhaps most critically, the experience to date helped investigators determine which patients might be optimal candidates for cellular therapy.

    “In the primary phase III trial, urethral hypermobility was not assessed, so many patients without primary sphincter dysfunction were likely included,” Dr. Kaufman explained. “Initial data review suggests that patients who have previously undergone urethral stabilization may be ideal candidates for sphincter augmentation.”

    Using the refined information from the initial trial, investigators are currently completing a randomized, double-blind, placebo-controlled trial assessing the safety and efficacy of AMDC urinary sphincter repair for treatment of SUI in women in the United States and Europe, and are planning a second study with two treatment injections.

    Dr. Kaufman and colleagues reported funding from Cook MyoSite, Inc.

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    Andrew Bowser
    Andrew Bowser is a medical writer based in Brooklyn, New York.

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