Vaginal Estrogen for the Treatment of Faecal Incontinence in Women

Not Applicable

Terminated

• Conditions: Fecal Incontinence

• Registration Number: NCT00307775
• Lead Sponsor: London North West Healthcare NHS Trust

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-27
• Study First Submitted QC: 2006-03-27
• Study First Posted: 2006-03-28
• Status Verified: 2007-02
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2012-04-28
• Last Update Posted: 2012-05-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement of symptoms and quality of life (QoL) as measured by QoL questionnaires and physiological assessment

Secondary Outcome Measures

Name	Time	Method
Acceptance of treatment mode delivery, through questionnaire

Trial Locations

Locations (1)

North West London Hospitals NHS Trust; 🇬🇧 London, United Kingdom