Vaginal Estrogen for the Treatment of Faecal Incontinence in Women

April 28, 2012 updated by: London North West Healthcare NHS Trust

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

Status

Terminated

Conditions

Intervention / 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 Type

Interventional

Enrollment

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, HA1 3UJ
        • North West London Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvement of symptoms and quality of life (QoL) as measured by QoL questionnaires and physiological assessment

Secondary Outcome Measures

Outcome Measure
Acceptance of treatment mode delivery, through questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London North West Healthcare NHS Trust

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

March 27, 2006

First Submitted That Met QC Criteria

March 27, 2006

First Posted (Estimate)

March 28, 2006

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 28, 2012

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06/VO1/6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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