Effects on Vaginal Health and Quality of Life in Postmenopausal Women Using Ultra Low Topic Estriol Before Vaginal Surgery for Pelvic Statics Disorders
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 88
- 主要终点
- Vaginal Health Indexes
研究概览
简要总结
The purpose of this study is to determine whether the vaginal estriol before vaginal surgery for pelvic statics disorders is more efficacy of no estriol treatment on vaginal health and quality of life.
详细描述
The aim of this randomized study was to evaluate the efficacy of low concentration of vaginal estriol gel (0.005%, 50 micrograms/1 g vaginal gel) in women with pelvic statics disorders before vaginal surgical treatment (group A), assessing the vaginal dryness, dysuria, vaginal maturation index (VMI), pH and the Vaginal Health Index (VHI). Secondary, to investigate the changes of sexual function and QoL. Women without pre surgical estriol treatment constituted the control group (group B).
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
- None
入排标准
- 年龄范围
- 56 Years 至 63 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •genital dryness,
- •irritation/burning/itching of vulvas or vagina
- •decreased lubrication with sexual activity
- •discomfort or pain with sexual activity
- •decreased arousal, orgasm, desire
排除标准
- •previous surgeries for pelvic organ prolapse
- •urinary incontinence
- •usage of medication
- •chronic medical illness
- •body mass index (BMI) ≥ 35 kg/m2
- •endometrial thickness equal to or greater than 4 mm
- •abnormal uterine bleeding
- •hormone-dependent malignancies
- •history of thromboembolic disease
- •liver disease
- •usage of HT for less than 3 months
- •usage of phytoestrogens within 1 month before the start of the study
- •partner affected by sexual disorder
- •conflicting with the partner
研究组 & 干预措施
Study Group on estriol vaginal gel
Drug: 1 g/daily of vaginal gel containing 50 μg of estriol (0.005%) for 3 weeks and then twice weekly for 9 weeks, for a complete cycle of treatment of 12 weeks
干预措施: estriol (Drug)
Study Group on estriol vaginal gel
Drug: 1 g/daily of vaginal gel containing 50 μg of estriol (0.005%) for 3 weeks and then twice weekly for 9 weeks, for a complete cycle of treatment of 12 weeks
干预措施: vaginal surgery (Procedure)
Control group, no estriol treatment
Procedure: vaginal surgery
干预措施: vaginal surgery (Procedure)
结局指标
主要结局
Vaginal Health Indexes
时间窗: vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks
次要结局
- QoL and sexual function were investigated by the Short Form 36 (SF-36)(vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks)
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12), respectively(vaginal gel containing 50 µg of estriol, daily, for a complete cycle of treatment of 12 weeks)
研究者
Salvatore Caruso
Professor of Gynecology, Clinic of Gynecology
Policlinico Universitario, Catania