A Pilot Study to Examine the Efficacy of Vaginally Administered Oestradiol in the Treatment of Faecal Incontinence in Post Menopausal Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fecal Incontinence
- Sponsor
- London North West Healthcare NHS Trust
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Improvement of symptoms and quality of life (QoL) as measured by QoL questionnaires and physiological assessment
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
Brief Summary
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?
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Post menopausal women with faecal incontinence
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Improvement of symptoms and quality of life (QoL) as measured by QoL questionnaires and physiological assessment
Secondary Outcomes
- Acceptance of treatment mode delivery, through questionnaire