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
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Examine the Efficacy of Vaginally Administered Oestradiol in the Treatment of Faecal Incontinence in Post Menopausal Women

Resource links provided by NLM:


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
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00307775     History of Changes
Other Study ID Numbers: 06/VO1/6
Study First Received: March 27, 2006
Last Updated: April 28, 2012
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

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on August 21, 2014