Background
Vaginal agenesis (VA) refers to the congenital absence of a vaginal canal often linked with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome. Current VA treatments include mechanical dilation and surgical vaginoplasty. Our vaginal expansion sleeve (VES) is a novel, transiently implanted device which lengthens the vaginal canal over time and is less complex and invasive than surgery or conventional dilation therapy which may improve patient compliance. Our study evaluated histologic effects of VES on rat vaginal tissue following VA.

Methods
Novel VES were made using a proprietary woven cylindrical material with helicoid trusses and flat resin caps. VES were used at 25-30mm in length depending on initial vaginal canal lengths and all VES pre-contracted to 50% of their original length. VES were then inserted and sutured into the vaginal canals of Sprague-Dawley rats (n=6) and allowed to spontaneously re-expand post-deployment. After one week, VES were removed and new vaginal lengths were measured. Rat vaginas were harvested en-bloc for histologic analysis. Test (n=6) and control (n=4) formalin-fixed paraffin-embedded tissues were stained with hematoxylin and eosin (H&E), Masson’s trichrome, and anti-Desmin immunochemical stain and evaluated.

Results
In 7days, mean vaginal canal lengths increased from 20.0 ± 2.4 mm to 23.8 ± 1.2 mm post-VES (n=6, p <.001), a 19% increase. H&E staining revealed increased submucosal eosinophilic inflammation in 5:6 of samples compared to 1:4 control tissues with an average 30.2 eosinophils per HPF (range: 16 - 38; median: 35). The test tissues also showed increased scattered neutrophils and lymphocytes in the mucosa and submucosa, with one test tissue having the longest VES (30mm) containing lymphocytic and neutrophilic inflammation. Desmin immunostaining and Masson’s trichrome staining both revealed a thinner muscularis with more infiltrative fibrous tissue between muscle fibers in the test tissues compared to control tissues.

Conclusion
VESs achieved significant vaginal lengthening. A positive correlation was observed between the VES length (and therefore tension generated in the vagina) and the degree of inflammation. The eosinophilia observed in the test tissues may indicate a localized, specific immune reaction to the VES device. The Desmin immunostain and Masson’s trichrome stain is consistent with muscularis remodeling. Future studies with longer durations of VES placement as well as serial implants with VESs of increasing lengths can inform longer-term remodeling of test tissues and help further characterize immune response associated with VES.

Histologic Changes in Rat Vaginal Tissue Following Vaginal Expansion Sleeve (VES) Implantation: Implications for Vaginal Agenesis Treatment

 Obstetrics and Gynecology

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