title: Anatomic and sexual outcomes after vaginoplasty using tissue-engineered biomaterial graft in patients with Mayer-Rokitansky-Küster-Hauser syndrome: a new minimally invasive and effective surgery.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China. zhu_julie@sina.com
authors.forename: Lan
authors.initials: L
authors.lastname: Zhu
authors.forename: Huimei
authors.initials: H
authors.lastname: Zhou
authors.forename: Zhixing
authors.initials: Z
authors.lastname: Sun
authors.forename: Wenjia
authors.initials: W
authors.lastname: Lou
authors.forename: Jinghe
authors.initials: J
authors.lastname: Lang
mesh_terms: D058489:46, XX Disorders of Sex Development / Q000601:surgery*; D062088:Acellular Dermis; D000328:Adult; D001672:Biocompatible Materials; D001828:Body Image; D016022:Case-Control Studies; D002681:China; D000013:Congenital Abnormalities / Q000601:surgery*; D005260:Female; D013509:Gynecologic Surgical Procedures; D006801:Humans; D009095:Mullerian Ducts / Q000002:abnormalities* / Q000601:surgery; D017060:Patient Satisfaction; D011446:Prospective Studies; D019651:Plastic Surgery Procedures; D019738:Surgically-Created Structures; D011795:Surveys and Questionnaires; D023822:Tissue Engineering; D016896:Treatment Outcome; D014621:Vagina / Q000002:abnormalities / Q000503:physiopathology / Q000601:surgery*; D055815:Young Adult
chemical_list: D001672:Biocompatible Materials