Regenerative Treatment of Female Genital Atrophy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy of PRP treatment
研究概览
简要总结
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.
详细描述
Introduction:
Vulvovaginal atrophy (VVA) is a condition associated with lower urinary tract dysfunction caused by decreased levels of estrogen and androgens, collectively referred to as genitourinary syndrome of menopause (GSM). Approximately 50% of postmenopausal women experience symptoms related to urogenital atrophy, which significantly impacts sexual function and quality of life (QoL) worldwide. These symptoms include vaginal dryness, irritation, dyspareunia, and recurrent infections, leading to discomfort, reduced intimacy, and emotional distress.
VVA symptoms are associated with decrements in quality of life that may be comparable to serious conditions such as arthritis, chronic obstructive pulmonary disease, asthma, and irritable bowel syndrome.
Contrary to vasomotor symptoms of menopause, which tend to diminish over time, GSM symptoms often worsen, leading to a greater impact on QoL and negatively affecting patients' confidence and intimacy with their partners. Current standard treatments, such as low-dose vaginal estrogens, are effective in alleviating symptoms but require continuous application, which can hinder adherence. Furthermore, these treatments are contraindicated in women with hormone-dependent cancers or a history of thrombotic events, leaving a significant population without effective therapeutic options.
Regenerative options include injection of materials into the vaginal such as PRP, fat graft, hyaluronic acid, botulinum toxin, and collagen, seems promising options, but to date their efficacy has not been reviewed, so further studies are required, and the procedures should be standardized to benefit more patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least one clinical complaint of VVA.
- •Discomfort (soreness, irritation)
- •Dyspareunia (sexual impaired function)
- •With or without urinary problems (incontinence, urgency, dysuria). Must report a contra-indication with the standard local hormonal treatment.
- •Burden side effects
- •Non-improvement with standard treatment
- •Hormonal cancer survivors must be in remission for two years after the last oncologic treatment.
- •Thrombotic disease patients must have the disease controlled and have passed 2 years after the thrombotic event.
- •Must have a cervicovaginal cytology confirming the atrophy, having ≤ 5% of superficial cells on vaginal smear. Moreover, a normal morphologic cytology besides the inflammatory or atrophy change is mandatory.
- •Must have a vaginal pH above 5 at baseline. Must have a normal mammography (American College of Radiology BI-RADS 1 or 2) within 12 months of study starts (Day 1), and normal breast examination.
- •Willing to participate in the study and sign an informed consent.
排除标准
- •Life expectancy < 6 months due to concomitant illnesses.
- •Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- •Active infectious disease. Patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have an expert consultation as to patient eligibility based on the patient's infectious status.
- •Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.
- •Patients on chronic immunosuppressive transplant therapy.
- •Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- •Used oral, transdermal, vaginal, intrauterine, implants/injectables drugs that contained either oestrogens, progestins, androgens, or selective oestrogen receptor modulators (SERMs) before the study (a washout period of 4 weeks is required). Use of prescription and non-prescription medications and remedies known to alleviate VVA, discomfort including vaginal lubricants and moisturizers, are allowed during the study.
- •Any allergic reaction to local anaesthetics.
- •Unwilling and/or not able to give written informed consent.
研究组 & 干预措施
PRP Group
GROUP A (18 patients) random assign from enrolled patients: Participants receive intradermal injections of autologous platelet-rich plasma (PRP) into the vulvar vestibule, followed by topical application of platelet-poor plasma (PPP) gel for 5 days.
干预措施: Mesotherapy with Autologous Platelet-Rich Plasma (PRP) to vulvovaginal area (Biological)
PRP Group
GROUP A (18 patients) random assign from enrolled patients: Participants receive intradermal injections of autologous platelet-rich plasma (PRP) into the vulvar vestibule, followed by topical application of platelet-poor plasma (PPP) gel for 5 days.
干预措施: Platelet-Poor Plasma Gel (Biological)
Placebo Group
GROUP B (12 patients) random assign from enrolled patients: Participants receive intradermal injections of saline solution into the vulvar vestibule, followed by topical application of platelet-poor plasma (PPP) gel for 5 days.
干预措施: Mesotherapy with saline solution (Other)
Placebo Group
GROUP B (12 patients) random assign from enrolled patients: Participants receive intradermal injections of saline solution into the vulvar vestibule, followed by topical application of platelet-poor plasma (PPP) gel for 5 days.
干预措施: Platelet-Poor Plasma Gel (Biological)
结局指标
主要结局
Efficacy of PRP treatment
时间窗: • T0 (Baseline): Initial evaluation • T1 (1 Month): 1ª treatment. • T2 (2 Months): 2º treatment. • T3 (3 Months): Follow-up evaluation • T4 (6 Months): Final evaluation, including symptom assessment, quality of life questionnaires, and laboratory tests.
Using SPSS software (version 26.0), the following statistical methods will be applied: * Descriptive Statistics: Means, standard deviations, frequencies, and percentages will summarize demographic and clinical characteristics. * Linear Mixed Models (LMMs): Used to evaluate changes in outcomes over time, controlling for assessment time and baseline characteristics. Adjusted means and 95% confidence interval. * Significance Testing: A p-value \<0.05 will be considered statistically significant. * Effect Size: Standardized treatment effect will be calculated as the mean difference in change between T0 and T4, divided by the standard deviation (SD) of that difference. Effect sizes will be categorized as small (0.2), medium (0.5), or large (0.8). A statistically significant improvement of VVA symptoms self-identified by subjects at baseline and a significant perception of improvement of quantitative assessment of genital health with the VVET scale .
次要结局
- Validation of a clinical Tool to visually classifying the severity of VVA and the characterization of the vulvovaginal area.(• T0 (Baseline): Initial evaluation • T3 (3 Months): Follow-up evaluation. • T4 (6 Months): Final evaluation)
研究者
AndreiaAntunes
affiliated investigator, PhD Student, Consultant of Gynecology and Obstetrics
Instituto Politécnico de Leiria