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Vaginal Estrogen for the Treatment of Faecal Incontinence in Women
This study has been completed.
Sponsored by: North West London Hospitals NHS Trust
Information provided by: North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00307775
  Purpose

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?

Condition Intervention
Fecal Incontinence
Drug: oestradiol

MedlinePlus related topics: Menopause Urinary Incontinence
Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Pilot Study to Examine the Efficacy of Vaginally Administered Oestradiol in the Treatment of Faecal Incontinence in Post Menopausal Women

Further study details as provided by North West London Hospitals NHS Trust:

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

Estimated Enrollment: 43
Study Start Date: March 2006
Estimated Study Completion Date: October 2007
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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307775

Locations
United Kingdom
North West London Hospitals NHS Trust
London, United Kingdom, HA1 3UJ
Sponsors and Collaborators
North West London Hospitals NHS Trust
Investigators
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
  More Information

North West London Hospitals NHS Trust web includes links to St Mark's  This link exits the ClinicalTrials.gov site

Study ID Numbers: 06/VO1/6
Study First Received: March 27, 2006
Last Updated: February 20, 2007
ClinicalTrials.gov Identifier: NCT00307775  
Health Authority: United Kingdom: National Health Service

Keywords provided by North West London Hospitals NHS Trust:
oestradiol, faecal incontinence, post menopausal
post menopausal women with faecal incontinence

Study placed in the following topic categories:
Fecal Incontinence
Benzoates
Gastrointestinal Diseases
Urination Disorders
Estradiol valerate
Estradiol 17 beta-cypionate
Intestinal Diseases
Rectal Diseases
Estradiol
Signs and Symptoms
Digestive System Diseases
Urologic Diseases
Estradiol 3-benzoate
Urinary Incontinence
Polyestradiol phosphate
Menopause

Additional relevant MeSH terms:
Urological Manifestations
Estrogens
Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009