Trial reportBMC women's health2019
Clinical pilot study to evaluate the neovaginal PACIENA prosthesis® for vaginoplasty without skin grafts in women with vaginal agenesis.
Trial report in BMC women's health, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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The trial behind it
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.
- Bioengineering trends in female reproduction: a systematic review.Human reproduction update · 2022Pooled it
- Management of congenital female genital tract anomalies related to primary amenorrhea and/or cyclic abdominal pain: A retrospective cohort study.Acta obstetricia et gynecologica Scandinavica · 2026Article
- Therapeutic Applications of 3D Bioprinting in Surgery for Female Reproductive Tract Disorders: A Systematic Review.Polymers · 2025Review
- Reconstructing the female reproductive system using 3D bioprinting in tissue engineering.Materials today. Bio · 2025Review
- Development and Applications of Organoids in Gynecological Diseases.Stem cell reviews and reports · 2025Review
- The Use of 3D Printing in Fetal Surgery for Surgical Planning: A Scoping Review.Journal of clinical medicine · 2024Article
- Review
- Histologic Analysis of 'Distraction Vaginogenesis' in a Rat Model.Pathophysiology : the official journal of the International Society for Pathophysiology · 2024Article
- Extracellular Matrix-Based and Electrospun Scaffolding Systems for Vaginal Reconstruction.Bioengineering (Basel, Switzerland) · 2023Review
- Developing biomedical engineering technologies for reproductive medicine.Smart medicine · 2022Review
- Retrospective comparative cohort study of neovagina creation by modified Vecchietti-laparoendoscopic single-site surgery for Mayer-Rokitansky-Küster-Hauser syndrome.Annals of translational medicine · 2022Article
- Genitourinary Tissue Engineering: Reconstruction and Research Models.Bioengineering (Basel, Switzerland) · 2021Review
- 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.Journal of clinical medicine · 2020Article
- Classical McIndoe Technique Versus the McIndoe Technique with a Neovaginal PACIENA ProsthesisJournal of clinical medicine · 2020Article
Corrections and comments
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Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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).
interventionsExtensive 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.
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