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

Abstract

Background: To 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.

Methods: This 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.

Results: In 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.

Conclusions: Good 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 registration: This 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.

Keywords: Neovaginal prosthesis; Rokitansky syndrome; Vaginal agenesis; Vaginoplasty.

Fig. 1

PACIENA prosthesis®. a Surgical prosthesis. b Coated silicone version of the prosthesis (the marks on the prosthesis correspond to 1 cm in length)

Fig. 2

Images of the sequence of observations in the studied cases. a Before and at the start of the operation in c5. b Introduction of the Interceed®-covered prosthesis in c2. c Prosthesis introduced in c3 with the adapted fixation plate and cross bandages for prosthesis support. d. After extracting the surgical prosthesis at 12 days in c7. e State and extraction of the surgical prosthesis at 12 days in c5. f With the silicone prosthesis after the change at 12 days in c1. g State and Schiller’s test at 3.5 months in c3. h Schiller’s test at 3.5 months in c4. i With the silicone prosthesis at 3.5 months in c3

Fig. 3

Vaginal biopsy at 6 months. a Well-structured, mature squamous epithelium (haematoxylin-eosin [H-E], × 40) in c4. b Intense staining for cytokeratin AE1-AE3 (CKAE1-AE3) on the surface of the fragment, which helps in recognizing the epithelium at that level and with greater magnification to see the epithelial positivity to cytokeratins (CKAE1-AE3, × 200). c Among abundant inflammatory polymorphic cells, the presence of keratin sheets (dyed more homogeneous pink) can be estimated. With greater magnification, the keratin sheets are more evident (H-E, × 400)