Vaginal Estrogen for the Treatment of Faecal Incontinence in Women

Fecal Incontinence Clinical Trial

Official title:

A Pilot Study to Examine the Efficacy of Vaginally Administered Oestradiol in the Treatment of Faecal Incontinence in Post Menopausal Women

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00307775
• Other study ID #: 06/VO1/6
• Status: Terminated
• Phase: N/A
• First received: March 27, 2006
• Last updated: April 28, 2012
• Start date: March 2006
• Est. completion date: October 2011

Study information

• Verified date: February 2007
• Source: London North West Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Drug:
• oestradiol

Locations

Country	Name	City	State
United Kingdom	North West London Hospitals NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
London North West Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of symptoms and quality of life (QoL) as measured by QoL questionnaires and physiological assessment
Secondary	Acceptance of treatment mode delivery, through questionnaire