Vaginal Estrogen for the Treatment of Faecal Incontinence in Women
Primary Purpose
Fecal Incontinence
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
oestradiol
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Incontinence focused on measuring oestradiol, faecal incontinence, post menopausal, post menopausal women with faecal incontinence
Eligibility Criteria
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
Sites / Locations
- North West London Hospitals NHS Trust
Outcomes
Primary Outcome Measures
Improvement of symptoms and quality of life (QoL) as measured by QoL questionnaires and physiological assessment
Secondary Outcome Measures
Acceptance of treatment mode delivery, through questionnaire
Full Information
NCT ID
NCT00307775
First Posted
March 27, 2006
Last Updated
April 28, 2012
Sponsor
London North West Healthcare NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT00307775
Brief Title
Vaginal Estrogen for the Treatment of Faecal Incontinence in Women
Official Title
A Pilot Study to Examine the Efficacy of Vaginally Administered Oestradiol in the Treatment of Faecal Incontinence in Post Menopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
March 2006 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
London North West Healthcare NHS Trust
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
oestradiol, faecal incontinence, post menopausal, post menopausal women with faecal incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
oestradiol
Primary Outcome Measure Information:
Title
Improvement of symptoms and quality of life (QoL) as measured by QoL questionnaires and physiological assessment
Secondary Outcome Measure Information:
Title
Acceptance of treatment mode delivery, through questionnaire
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathy Abernethy, RN ENB
Organizational Affiliation
London North West Healthcare NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joan Pitkin, MB BS BSc FRCS FRCOG
Organizational Affiliation
London North West Healthcare NHS Trust
Official's Role
Study Chair
Facility Information:
Facility Name
North West London Hospitals NHS Trust
City
London
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Vaginal Estrogen for the Treatment of Faecal Incontinence in Women
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