A Pilot Study to Examine the Efficacy of Vaginally Administered Oestradiol in the Treatment of Faecal Incontinence in Post Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Improvement of symptoms and quality of life (QoL) as measured by QoL questionnaires and physiological assessment
研究概览
简要总结
This study will address the following questions:
- Does the use of oestrogen inserted vaginally with an applicator, help with the symptoms of faecal (bowel) incontinence in women who are past the age of menopause?
- Do women find it easy to use?
- Is the treatment safe for the womb lining?
- Is there any systemic absorption of the treatment?
详细描述
Faecal incontinence affects about 5% of women, the most common cause is often cited by women as obstetric trauma. However in clinical practice many women report that their symptoms of faecal incontinence begin around the same time as menopause. A community survey examining the prevalence of faecal incontinence in menopausal women is in progress. If a correlation is found between the onset of menopause and the development of faecal incontinence, further investigation of effective treatment will be indicated.
The investigators want to investigate whether vaginally administered oestradiol can alleviate or improve symptoms in women who have faecal incontinence after the menopause. This is a pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post menopausal women with faecal incontinence
排除标准
- •No hormone replacement therapy (HRT) for at least 8 weeks prior to screening
- •Diabetes mellitus
- •Neurological disorder
- •Terminal illness
- •Current treatment for breast cancer
- •Unable to give informed consent
结局指标
主要结局
Improvement of symptoms and quality of life (QoL) as measured by QoL questionnaires and physiological assessment
次要结局
- Acceptance of treatment mode delivery, through questionnaire