Clinical pilot study to evaluate the neovaginal PACIENA prosthesis® for vaginoplasty without skin grafts in women with vaginal agenesis

Abstract

BackgroundTo evaluate the feasibility and clinical outcomes of vaginoplasties using a neovaginal polylactic acid prosthesis made with 3-dimensional (3D) printing technology as an intraneovaginal mould.MethodsThis was an interventionist, prospective, and multicentre clinical pilot investigation of a sanitary product (PACIENA prosthesis®) aiming to recruit and operate on 8 patients over 6 months with a follow-up period of 6 months. Only six patients with Rokitansky syndrome and one patient with Morris syndrome (7 patients in total) were operated on in two university hospitals: “La Fe”, Valencia (H1) and “Arrixaca”, Murcia (H2). Interventions: Extensive surgical dissection of a defined space between the urethra and bladder in the front and of the rectum in the back as well as insertion of the PACIENA prosthesis® covered with Interceed® were performed. After 12 days, the prosthesis was changed to the silicone-covered version for daily application.ResultsIn the 6 patients with Rokitansky syndrome (86%), the primary endpoint (satisfactory vaginal outcome in terms of appearance, function, and sensation without relevant additional morbidity) was achieved, although only 2 patients (28%) were sexually active at the end of 6 months of follow-up. The patient with Morris syndrome withdrew from the study after 1 month. Patients without bacterial colonization showed positive Schiller tests at 1 month, and subsequent biopsies showed adequate keratinization and epidermization. Epithelization and iodopositivity were delayed in the patients who developed inflammatory granulomas.ConclusionsGood anatomical and functional results can be achieved with the PACIENA prosthesis® for vaginoplasties without skin grafts. However, adequate patient selection and education, good surgical techniques and haemostasis, postoperative support, and prevention of bacterial colonization are important.Trial registrationThis clinical study was approved by the Ethical Clinical Investigation Committee of San Juan University Hospital on September 27, 2016, to be conducted in the participating centres; it was authorized by the Spanish Agency of Medicines and Health Products (AEMPS) on April 24, 2017 (exp. no. 585/16/EC), to be carried out in that hospitals.

Comparison of the modified laparoscopic Vecchietti and Davydov colpoplasty techniques in Mayer‐Rokitansky‐Küster‐Hauser syndrome: A long‐term follow‐up analysis

“…The modified Davydov technique is appropriate in patients with a short genital hiatus (less than 3 cm) which is a relative contraindication for the creation of a neovagina using the laparoscopic Vecchietti technique. Neovaginal granulomas were more common in patients from the modified Davydov group, which could delay epithelization of the vagina 13 . These patients with granulomas complained of painless vaginal spotting or bleeding after intercourse.…”

“…Neovaginal granulomas were more common in patients from the modified Davydov group, which could delay epithelization of the vagina. 13 These patients with granulomas complained of painless vaginal spotting or bleeding after intercourse. In this study, the granulomatous polyps were removed on time with ring forceps, followed by the application of Mupirocin cream (Bactroban).…”

Could Training in an Anatomical Model Be Useful to Teach Different Neovagina Surgical Techniques? A Descriptive Study about Knowledge and Experience of Techniques for Neovagina Surgery

“…In the video, a modification of the McIndoe technique is presented. Such a modification avoids the use of a skin graft by using a polylactic acid vaginal prosthesis covered by Interceed ® , which favors re-epithelialization of the surgical bed [12]. This fact is important because it simplifies the surgery, avoiding complications and maintaining its effectiveness.…”

Retrospective comparative cohort study of neovagina creation by modified Vecchietti-laparoendoscopic single-site surgery for Mayer-Rokitansky-Küster-Hauser syndrome

“…Müllerian aplasia is not indicated by a vaginal transverse septum or an imperforate hymen (15). Ultrasound is a valuable diagnostic technique for precisely defining pelvic anatomy (16)(17)(18).…”