Fecal IncontinenceNCT00307775
Vaginal Estrogen for the Treatment of Faecal Incontinence in Women
A study testing oestradiol in people with Fecal Incontinence, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- oestradiol
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2006to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post menopausal women with faecal incontinence
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
North West London Hospitals NHS Trust
London, HA1 3UJ
About this study
Official title: 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?
Read the 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.
- Conditions
- Fecal Incontinence
- Being tested
- oestradiol
- Keywords
- oestradiol, faecal incontinence, post menopausal, post menopausal women with faecal incontinence
- Medical subject headings
- Fecal Incontinence, Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oestradiolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of symptoms and quality of life (QoL) as measured by QoL questionnaires and physiological assessment
Secondary outcomes (1)
Acceptance of treatment mode delivery, through questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Kathy Abernethy, RN ENB, Principal investigator, London North West Healthcare NHS TrustJoan Pitkin, MB BS BSc FRCS FRCOG, Study chair, London North West Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307775
- Sponsor's protocol ID
- 06/VO1/6
- Status last verified
- Feb 2007
- First submitted
- 27 Mar 2006
- Last updated
- 1 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Examine the Efficacy of Vaginally Administered Oestradiol in the Treatment of Faecal Incontinence in Post Menopausal Women
- ClinicalTrials.gov ID
- NCT00307775
- Acronym / sponsor ID
- 06/VO1/6
- Conditions
- Fecal Incontinence
- Keywords
- oestradiol, faecal incontinence, post menopausal, post menopausal women with faecal incontinence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 43 participants
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 28 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post menopausal women with faecal incontinence
Key exclusion criteria (6 listed)
- No hormone replacement therapy (HRT) for at least 8 weeks prior to screening
- Diabetes mellitus
- Neurological disorder
- Terminal illness
- Current treatment for breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oestradiol | Drug | – |
Primary outcome
Improvement of symptoms and quality of life (QoL) as measured by QoL questionnaires and physiological assessment
1 secondary outcome
Acceptance of treatment mode delivery, through questionnaire
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathy Abernethy, RN ENB principal investigator
London North West Healthcare NHS Trust
Joan Pitkin, MB BS BSc FRCS FRCOG study chair
London North West Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oestradiol in people with Fecal Incontinence, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of symptoms and quality of life (QoL) as measured by QoL questionnaires and physiological assessment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2012.