4.4 Article

A preliminary evaluation of in vivo response to a filament-wound macroporous collagen midurethral sling in an ovine model

Publisher

WILEY
DOI: 10.1002/jbm.b.35120

Keywords

collagen; ovine model; sling; stress urinary incontinence

Funding

  1. University Hospitals Technology Validation Startup Fund
  2. Third Frontier Program of the Ohio Development Services Agency [TECG20170071]
  3. National Institute of Health [R21HD095439]
  4. National Science Foundation [1913847]
  5. Directorate For Engineering [1913847] Funding Source: National Science Foundation
  6. Div Of Industrial Innovation & Partnersh [1913847] Funding Source: National Science Foundation

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This study evaluated the in vivo response to collagen slings implanted in an ovine model and found that collagen slings demonstrated biocompatibility and tissue ingrowth ability.
Stress urinary incontinence (SUI) impacts similar to 1/3 of women over age 50. Negative publicity around PP meshes used in pelvic prolapse repair drives the need for identifying alternative biomaterials for SUI repair. Our study evaluated in vivo response to collagen sling implanted in an ovine model. Electrocompacted collagen threads were filament wound as slings and crosslinked in genipin. Collagen slings were implanted suburethrally mimicking the transvaginal tape technique. Main study groups were: Collagen sling (n = 3, 6 months) and PP sling (n = 3, 6 months). Collagen sling was also tested at 3-weeks (n = 1) to observe early-stage tissue response and 1-year (n = 2) to assess biomaterial longevity in a preliminary capacity. Collagen slings healed to a fibrous ligament texture at 6 months and maintained such texture to 1 year. Histological scoring indicated biocompatible responses to collagen slings with no adverse events. All study groups exhibited complete tissue ingrowth and interstitial de novo collagen deposition at all time points. Collagen threads induced orderly de novo collagen deposition that was aligned along long axes of threads. Tissue infiltrated collagen slings that were explanted at 6 and 12 months presented similar structural strength with native tissues such as vagina and fascia, and PP (Lynx) slings (p > .05). With the limitation of low number of animals per time point in hindsight, this preliminary study justifies evaluation of collagen slings in a larger sample size of animals, particularly to assess persistence of ligamentous tissue response over longer durations than 1-year.

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