Introduction: Recent years have seen continuous reports about the successful reconstruction of numerous organs with the application of tissue-engineering techniques. Thus, we assess the outcomes for vagina reconstruction using tissue-engineered biological material, which we suggested previously as an ideal graft for vaginoplasty.
Aim: To evaluate the anatomic and sexual outcomes in patients undergoing vaginoplasty using tissue-engineered biomaterial mesh.
Methods: This prospective study included 53 patients with Mayer-Rokitansky-Küster-Hauser syndrome admitted to our hospital. Patients underwent vaginoplasty with tissue-engineered biological material (acellular dermal matrix). Postoperatively, a silicone vaginal dilator (length: 10 cm, diameter: 3.5 cm) was advised to be used for the first 3-6 months to prevent contraction of the neovagina. Follow-up was performed at 4 weeks, 12 weeks, 12 months, and then annually. Twenty-four age-matched women who underwent health examinations during the same time period were selected as a health control group and answered Female Sexual Function Index (FSFI) questionnaires for the purpose of comparing sexuality.
Main outcome measures: Anatomic success was defined by a vaginal length ≥ 8 cm and a width allowing the easy introduction of two fingers. Sexual outcomes were assessed at the 12-month follow-up according to body image perception and FSFI questionnaires validated for the Chinese-speaking population.
Results: No severe intra-operative complications occurred. No graft-related infection, rejection, or detachment was recorded. The cost for tissue-engineered biomaterial graft was $1,900 (¥ 12,000) per person. Postoperatively, granulomatous polyps occurred in 6/53 patients (11.3%) at the vaginal vault and were removed in an outpatient clinic. During a mean follow-up of 21.1 months, the anatomic success rate was 100%, and all of the patients were satisfied with their body image. Postoperatively, 42 patients were followed up for more than 1 year, and 32 of them were sexually active. Among the 24/32 patients (75%) who answered the FSFI questionnaire, the mean total FSFI score was 26.7 ± 3.5, which was similar to that of the control group (25.6 ± 7.4, P = 0.46). The similarity was also observed in six separate domains of the functional aspect of female sexuality.
Conclusions: Vaginoplasty with tissue-engineered biomaterial graft is a safe, effective, minimally invasive cosmetic procedure that provides near normal sexual function for patients with vaginal aplasia.
© 2013 International Society for Sexual Medicine.