Vaginal Estrogen for the Treatment of Faecal Incontinence in Women
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?
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study to Examine the Efficacy of Vaginally Administered Oestradiol in the Treatment of Faecal Incontinence in Post Menopausal Women|
- Improvement of symptoms and quality of life (QoL) as measured by QoL questionnaires and physiological assessment
- Acceptance of treatment mode delivery, through questionnaire
|Study Start Date:||March 2006|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307775
|North West London Hospitals NHS Trust|
|London, United Kingdom, HA1 3UJ|
|Principal Investigator:||Kathy Abernethy, RN ENB||London North West Healthcare NHS Trust|
|Study Chair:||Joan Pitkin, MB BS BSc FRCS FRCOG||London North West Healthcare NHS Trust|