Regenerative Treatment of Female Genital Atrophy

Summary

Vulvovaginal health is a key aspect of active and healthy aging for all women. Hormonal deprivation that occurs during menopause significantly affects the anatomy and function of urogenital tissues, leading to their atrophy. Vaginal creams and suppositories containing estrogens are the standard treatment and can improve this condition. However, they require continuous application, which often makes adherence to treatment challenging. Additionally, women with hormone-dependent tumors, such as most breast cancers and many gynecological cancers, are even more affected by this issue. These women are often treated with anti-estrogen medications, undergo radio or chemotherapy, and are frequently younger, with the added complication that the standard treatment is contraindicated for them. To address this important issue, the study titled "Regenerative Treatment of Female Genital Atrophy" was developed. If you meet the required criteria, we would like to invite you to participate. Inclusion Criteria: * Clinical complaints of genital atrophy (e.g., dryness, burning, itching, discomfort, or pain during intercourse). * Contraindication to standard local hormonal treatment (e.g., allergy, bothersome side effects, lack of improvement with standard treatment, history of hormone-dependent cancer, or thrombotic event treated at least two years ago). This study focuses on Regenerative Medicine, which aims to support the regeneration of cells, tissues, or organs in the human body to restore normal function. This field holds significant curative and preventive potential. The selected regenerative treatment, widely used in various medical fields (such as dentistry and orthopedics), is derived from the patient's own body, making it a natural and safe option with minimal side effects. This treatment, known as platelet-rich plasma (PRP), has shown effectiveness in improving the firmness, elasticity, hydration, and thickness of the vulva and vagina. However, further research is required to assess the effectiveness of PRP specifically in the external female genital area. What is PRP - Platelet-Rich Plasma? PRP is a substance obtained from the patient's own blood. Blood is composed of several components, including red blood cells, white blood cells, plasma, and platelets. Platelets are small cell fragments that play a crucial role in blood clotting and wound healing. PRP is created by taking a small sample of the patient's blood and processing it in a centrifuge to concentrate the platelets within the plasma. This concentrated plasma, rich in growth factors and proteins, is then injected into the target area to stimulate tissue regeneration and repair. Because PRP is derived from the patient's own body, it is considered a natural and safe treatment with a very low risk of adverse reactions. PRP is obtained by collecting a small amount of the patient's blood. After a carefully standardized preparation process, the PRP is injected into the vulvovaginal area under local anesthesia. Study Location: Gynecology Department of Santo André Hospital, Leiria, at the Genital Atrophy Clinic. Study Protocol: * Initial evaluation consultation. * First treatment intervention. * Follow up approximately one month after the first treatment and second treatment intervention. * Another follow-up approximately one month after the second treatment. * Final evaluation six months after the start of the study. Participants are divided into two groups: one group receives PRP treatment, while the other receives a placebo (serum). At the end of the study, participants in the placebo group will have the option to undergo PRP treatment. This is a double-blind study designed to evaluate the efficacy of PRP in the female external genital area.

Timeline

Start

2024-06-04

Primary completion

2025-06-18

Completion

2025-11-26

Publications

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• Background Goldstein AT, Mitchell L, Govind V, Heller D. A randomized double-blind placebo-controlled trial of autologous platelet-rich plasma intradermal injections for the treatment of vulvar lichen sclerosus. J Am Acad Dermatol. 2019 Jun;80(6):1788-1789. doi: 10.1016/j.jaad.2018.12.060. Epub 2019 Jan 11. No abstract available.
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• Background Cho MJ, Rohrich RJ. Level of Evidence on Platelet-rich Plasma in Plastic Surgery. Plast Reconstr Surg Glob Open. 2021 Apr 15;9(4):e3379. doi: 10.1097/GOX.0000000000003379. eCollection 2021 Apr.
• Background Sclafani AP, McCormick SA. Induction of dermal collagenesis, angiogenesis, and adipogenesis in human skin by injection of platelet-rich fibrin matrix. Arch Facial Plast Surg. 2012 Mar-Apr;14(2):132-6. doi: 10.1001/archfacial.2011.784. Epub 2011 Oct 17.
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• Background Aguilar P, Hersant B, SidAhmed-Mezi M, Bosc R, Vidal L, Meningaud JP. Novel technique of vulvo-vaginal rejuvenation by lipofilling and injection of combined platelet-rich-plasma and hyaluronic acid: a case-report. Springerplus. 2016 Jul 26;5(1):1184. doi: 10.1186/s40064-016-2840-y. eCollection 2016.
• Background Kim SH, Park ES, Kim TH. Rejuvenation Using Platelet-rich Plasma and Lipofilling for Vaginal Atrophy and Lichen Sclerosus. J Menopausal Med. 2017 Apr;23(1):63-68. doi: 10.6118/jmm.2017.23.1.63. Epub 2017 Apr 28.
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Drugs

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