Vaginal Estrogen for the Treatment of Faecal Incontinence in Women

London North West Healthcare NHS Trust

Status: Terminated

Conditions: Fecal Incontinence

Treatments: Drug: oestradiol

Study type: Interventional

Funder types: Other

Identifiers

NCT00307775

06/VO1/6

Details and patient eligibility

About

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?

Full 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.

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)