Investigation of the Effects of Local Estrogen Administration on Vaginal, Periurethral and Urinary Microbiota in Genitourinary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Vaginal, periurethral and urinary bladder microbiota
研究概览
简要总结
Genitourinary syndrome (GUS) is a disease seen in menopause, which significantly reduces the quality of life of patients. Microbiota studies in GUS are mostly related to vaginal microbiota. However, although urinary problems are also common in GUS, there are less studies on urobiome and no studies on periurethral microbiota. It is recently shown that especially in patients with dyspareunia vaginal microbiota mostly consists of Streptococcus species. As periurethral tissues are close to the skin it is reasonable to think that periurethra and vaginal opening may be colonised by aerobic bacteria which causes the symptoms like burning sensation and dyspareunia. The hypothesis of the study is that vaginal dysbiosis and related aerobic bacteria that become dominant in the periurethral microbiota may be responsible for the emergence of symptoms in menopausal patients with genitourinary syndrome. Changes in the vaginal microbiota with vaginal estrogen therapy will lead to changes in the urobiome and periurethral microbiota. Our aim is to determine the vaginal, periurethral and urinary microbiota content of menopausal women with genitourinary syndrome, to determine the effect of local estrogen therapy on them, and to examine whether there is a difference between these 3 microbiota.
详细描述
Problems addressed by the study:
Genitourinary syndrome (GUS) is a common disorder during menopause, reported to be at least 50% in many series, which reduces quality of life. Unfortunately, despite being such a common disorder, patients do not report their complaints about this issue and clinicians do not question patients about this condition (NAMS, 2020). There is little awareness about the subject and relatively few studies on the pathophysiology and treatment of the disease.
GUS is diagnosed clinically. Symptoms such as vulvovaginal dryness, burning or irritation; dyspareunia; and symptoms such as urge incontinence, dysuria or recurrent urinary tract infections are observed in the urinary system (NAMS, 2020). Urinary symptoms of GUS, such as dysuria, are often confused with recurrent urinary tract infections. The pathophysiology of GUS is often attributed to estrogen deficiency, but some researchers suggest that these changes may also be related to the vaginal microbiome (Hummelen et al., 2011). Because while estrogen deficiency is present in all women who enter menopause, GUS is observed in a certain portion. Therefore, our study will contribute to the literature aimed at shedding light on the pathogenesis.
Although there are both vaginal and urinary symptoms in GUS, the most studies are on vaginal microbiota. There is only one study on urinary microbiota (Lillemon et al., 2022). There is no study evaluating the periurethral microbiota.
Is there a relationship between vaginal microbiota and GUS symptoms?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients who have been in menopause for at least 1 year
- •Patients with symptoms of genitourinary syndrome (those with symptoms such as vaginal dryness, frequent urination, burning sensation during urination, pain during intercourse)
排除标准
- •Patients with severe overactive bladder symptoms
- •Patients receiving systemic hormone replacement therapy or local estrogen therapy or have received it within the last 3 months
- •Patients using vaginal probiotic products
- •Patients with advanced pelvic organ prolapse
- •Patients with a history of estrogen-dependent breast or endometrial cancer
- •Patients allergic to local estrogen
- •Patients with urinary tract infection at first presentation or patients who have used antibiotics within the last 2 weeks
研究组 & 干预措施
GUS-estriol
Patients with GUS symptoms and examination findings, who are treated with vaginal oestrogen cream
干预措施: Vaginal Cream with Applicator (Drug)
结局指标
主要结局
Vaginal, periurethral and urinary bladder microbiota
时间窗: 3 months
Microbiota contents of 3 areas (vagina, periurethra and bladder) will be obtain and compared to each other
次要结局
未报告次要终点
研究者
Sebile Guler Cekic
MD-PhD
Koc University Hospital