ISRCTN46661996已完成未知
ocal Oestrogen Treatment in postmenopausal women Undergoing pelvic organ prolapse Surgery (LOTUS) feasibility study
Birmingham & Black Country (University Hospital Birmingham NHS Foundation Trust)0 个研究点目标入组 100 人开始时间: 2015年5月28日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32912971/ results (added 15/09/2020) 2020 Results article in https://doi.org/10.1007/s00192-020-04480-5 (added 14/06/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Postmenopausal women
- •2. Consented to undergo surgical intervention for pelvic organ prolapse
- •3. Have not received HRT in the last 12 months
- •4. Willing to be randomised
- •5. Give written informed consent; Target Gender: Female; Upper Age Limit 90 years ; Lower Age Limit 30 years
排除标准
- •1. Previous breast or uterine malignancy or other hormone dependent neoplasms
- •2. Genital bleeding of unknown origin
- •3. Previous thromboembolic episodes in relation to oestrogen therapy
- •4. Women who cannot understand speak or write in English
- •5. Women known to be allergic to any of the components of vaginal oestrogens
- •6. Two or more episodes of culture positive UTI in the last 6 months
- •7. Previous POP surgery
- •8. Voiding dysfunction(PVR>150ml)
- •9. Current or previous POP surgery involving mesh
研究者
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