Vaginal Estrogen for the Treatment of Faecal Incontinence in Women

This study has been terminated.
(Lack of recruitment)
Sponsor:
Information provided by:
North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00307775
First received: March 27, 2006
Last updated: April 28, 2012
Last verified: February 2007

March 27, 2006
April 28, 2012
March 2006
October 2011   (final data collection date for primary outcome measure)
Improvement of symptoms and quality of life (QoL) as measured by QoL questionnaires and physiological assessment
Improvement of symptoms and quality of life as measured by QoL questionnaires and physiological assessment
Complete list of historical versions of study NCT00307775 on ClinicalTrials.gov Archive Site
Acceptance of treatment mode delivery, through questionnaire
Same as current
Not Provided
Not Provided
 
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

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?

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Fecal Incontinence
Drug: oestradiol
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
43
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Female
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00307775
06/VO1/6
Not Provided
Not Provided
North West London Hospitals NHS Trust
Not Provided
Principal Investigator: Kathy Abernethy, RN ENB North West London Hospitals NHS Trust
Study Chair: Joan Pitkin, MB BS BSc FRCS FRCOG North West London Hospitals NHS Trust
North West London Hospitals NHS Trust
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP