Skip to content

Vaginal Estrogen for the Treatment of Faecal Incontinence in Women

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00307775
Enrollment
43
Registered
2006-03-28
Start date
2006-03-31
Completion date
2011-10-31
Last updated
2012-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fecal Incontinence

Keywords

oestradiol, faecal incontinence, post menopausal, post menopausal women with faecal incontinence

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.

Interventions

Sponsors

London North West Healthcare NHS Trust
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Improvement of symptoms and quality of life (QoL) as measured by QoL questionnaires and physiological assessment

Secondary

MeasureTime frame
Acceptance of treatment mode delivery, through questionnaire

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026