Urethral Bulking With Polymethylmethacrylate Microspheres for Stress Urinary Incontinence: Tissue Persistence and Safety Studies in Miniswine - 20/08/11
, Patrick B. Lappin a, b, Corbett Stone a, b, Stefan M. Lemperle a, b
Reprint requests: Gottfried Lemperle, M.D., Ph.D., Division of Plastic Surgery, University of California, San Diego, School of Medicine, 302 Prospect Street, La Jolla, CA 92037Résumé |
Objectives |
To evaluate the safety and persistence of injectable polymethylmethacrylate (PMMA) microspheres as a long-lasting urethral bulking agent in pigs. PMMA microspheres of 2 different diameters (40 and 125 μm) were tested to investigate the potential for migration and dislocation after injection. A similar product containing 40-μm PMMA microspheres has been used as an injectable wrinkle filler for >25 years and received Food and Drug Administration approval in 2006 (ArteFill).
Methods |
A total of 22 female pigs received 4 submucosal implantations of PMMA microspheres, using either a cystoscope or a newly developed urethral injection device (UroScope). At death and necropsy at 8 days and 1, 3, and 6 months, the urethral injection site, liver, lung, spleen, and pelvic and iliac lymph nodes were processed for histologic examination and microsphere count using organ dissolution and microscopy.
Results |
All injected submucosal blebs were still present at 6 months and showed no signs of inflammation. Tissue dissolution of the local lymph nodes and major organs demonstrated the transport of some of the 40-μm microspheres to the local lymph nodes and lung but not to the liver or spleen. In contrast, no 125-μm microspheres were detected in any distant organ.
Conclusions |
The submucosal implantation of 125-μm PMMA microspheres into the urethra provided a safe and persistent bulking effect in pigs. The positive results of the present study encourage additional investigation of 125-μm PMMA microspheres as a long-lasting bulking agent for the treatment of female stress urinary incontinence. Furthermore, a newly developed urethral injection device (UroScope) proved beneficial and cost-effective to facilitate the transurethral injections of 125-μm PMMA microspheres.
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| This study was sponsored by Artes Medical, San Diego, CA; at the time of the experiments, Drs. Gottfried and Lemperle were employees of Artes Medical; Drs. Lemperle and Lappin and Mr. Stone have no financial interest in any of the tested or mentioned products. |
Vol 77 - N° 4
P. 1005.e1-1005.e7 - avril 2011 Retour au numéro
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