AUA 2009: Autologous Muscle Cell Implantation Improves Stress Urinary Incontinence

Martha Kerr

May 03, 2009

May 3, 2009 (Chicago, Illinois) — Long-term follow-up of women with stress urinary incontinence shows that injections of autologous muscle cells, derived from the quadriceps femoris, into various sites around the urethral sphincter complex, shows that the procedure resulted in a "striking" improvement in symptoms in more than three quarters of patients treated.

Results were presented here at the 2009 annual meeting of the American Urological Association by lead investigator Lesley K. Carr, MD, of the Division of Urology at the University of Toronto and Sunnybrook Health Sciences Center in Ontario, Canada.

The study involved 29 women (mean age, 49.5 years) with stress urinary incontinence, 20 of whom received high-dose and 9 of whom received low-dose muscle cell injections. A second course of injections 3 months later was given on request to 25 of the 29 women, per study protocol. Dr. Carr presented the 12-month follow-up data.

"There was only 1 case of symptom worsening and 1 case of urinary retention," Dr. Carr told Medscape Urology. "There was a greater than 50% improvement in symptoms in 76.5% of the women. In fact, all those women were dry at follow-up," she reported.

Urinary leaks were reduced after both injections. At 12 months, 13 (76.5%) of 17 patients reported an overall reduction in stress leaks and urgency compared with baseline. Four patients reported no leaks on questionnaire, but Dr. Carr reported even higher continence rates on follow-up clinical examination.

Minor events occurred at similar rates among all dose groups. These included pain and bruising at the muscle biopsy site, pain at the injection site, mild and limited urinary retention, and urinary tract infections.

Quality of life improved in 68% of patients at 3 months after the first injection, and in 67% at 3 months after the second injection. Symptoms improved in 61% of patients at 3 months after the first injection and at 3 months after the second injection.

"We believe we are seeing better efficacy and a faster response with the higher dose," Dr. Carr said. "We think the muscle cells have a short-term response, with growth factors and host remodeling. With the long-term results we are reporting here, there appears to be new muscle that has been generated by the original transplanted cells...and we are seeing continuing improvement in results over time."

AUA spokesman Anthony Atala, MD, director of the Wake Forest Institute for Regenerative Medicine at Wake Forest University Health Sciences and the chair of the Department of Urology at Winston-Salem, North Carolina, told Medscape Urology that the injections are done on an outpatient basis. "There is no restriction in activity afterward as there is with other surgical procedures to correct stress incontinence."

The results have been significant enough to expand the trial to 4 clinical sites, including 3 in the United States, Dr. Carr reported.

The study was funded by Cook Myosite, Inc. Dr. Atala has disclosed no relevant financial relationships.

American Urological Association (AUA) 104th Annual Scientific Meeting: Abstract 1526. Presented April 28, 2009.

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