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

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 (R)) aiming to recruit and operate on 8 patients over 6months with a follow-up period of 6months. 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 (R) covered with Interceed (R) were performed. After 12days, 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 6months of follow-up. The patient with Morris syndrome withdrew from the study after 1month. Patients without bacterial colonization showed positive Schiller tests at 1month, 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 (R) 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.