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Vaginal Estrogen With Pessary Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Lawson Health Research Institute
Sponsor:
Collaborators:
Academic Medical Organization of Southwestern Ontario
University of Western Ontario, Canada
Information provided by (Responsible Party):
Queena Chou, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01843166
First received: July 8, 2012
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

Patients presenting with pelvic organ prolapse will be offered the use of a pessary. Vaginal estrogen cream treatment with the pessary will be randomized amongst the patients and patient satisfaction and complication rates will be assessed during follow-up.


Condition Intervention
Vaginal Infection
Urinary Tract Infection
Quality of Life
Drug: Premarin vaginal cream
Drug: Placebo cream

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Use of Vaginal Estrogen With Pessary Treatment of Pelvic Organ Prolapse and Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Vaginal infections [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
    Vaginal swabs at each follow up visit will be used to detect presence or absence of vaginal infection. A total count of vaginal infections per patient will be compared between groups.


Secondary Outcome Measures:
  • Frequency of urinary tract infection [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
    Urine samples at each follow-up visit will be used to detect the presence or absence of a urinary tract infection.

  • Quality of life [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
    Patients will complete validated questionnaires to assess quality of life with respect to urinary, bowel, and sexual function.


Estimated Enrollment: 150
Study Start Date: July 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment group
These patients will utilize a pessary and be given instructions for use and prescription for Premarin vaginal cream 2g at bedtime twice weekly.
Drug: Premarin vaginal cream
2g at bedtime twice weekly
Placebo Comparator: Control group
These patients will utilize a pessary with an inactive placebo cream.
Drug: Placebo cream
2g at bedtime twice weekly

Detailed Description:

This will be a double-blinded, placebo-controlled, randomized controlled trial. Eligible patients presenting to the urogynaecology clinic with pelvic organ prolapse will be offered management with a pessary and participation in the study

Patients who agree to participate in the study will be given a consent form

Patients in the study and thus those who have opted for pessary use will be randomized between two groups:

  1. Treatment group - will be given instructions for use and prescription for Premarin vaginal cream 2g at bedtime twice weekly
  2. Control group - will utilize pessary with an inactive placebo cream

Both the patient and the investigators will be blinded to patient treatment.

If a patient has expressed willingness to participate in the study over the phone, the research assistant will issue a study number to the patient and pick up the corresponding cream from the LHSC pharmacy to give to the patient at their next clinic visit. The cream will be provided to the patient once they have read the letter of information and signed the consent form.

For follow-up visits, the research assistant will monitor appointment bookings to ensure that the cream is ready in the clinic when the patient has their next follow-up visit.

Patients of both groups will be fitted with a pessary. Pessary fitting will be individualized due to differences in pelvic size and shape and degree of prolapse. Patients may return to the clinic for subsequent fittings until a successful fit has been achieved. An unsuccessful fitting is defined as discontinued pessary use due to discomfort or expulsion.

Patients will be assessed for satisfaction and complications 6 wks, 18 wks, 36 wks and 60 wks after the successful fitting.

To determine patient satisfaction and complications, patients will complete a compilation of validated questionnaires assessing urinary symptoms, sexual function and quality of life at each follow-up.

At each follow-up, a vaginal exam will be done and a vaginal swab and urine sample (for urinalysis and culture and sensitivities) will be taken to assess vaginal bleeding and infections.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient presenting to the clinic with pelvic organ prolapse will be offered management with a pessary and will be offered participation in the study.

Exclusion Criteria:

  • have a contraindication to the use of estrogen cream or products
  • have any allergy to the use of estrogen cream or products
  • have a past medical or family history of breast cancer
  • have a past medical history of thromboembolism, myocardial infarction and stroke or are pregnant
  • have previously used Premarin vaginal cream
  • are currently using oral estrogen
  • are not competent to 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: NCT01843166

Contacts
Contact: Queena Chou, MD 519-646-6343 Queena.Chou@lhsc.on.ca
Contact: Jennifer Cordick, MA 519-685-8500 ext 53508 jennifer.cordick@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre, University of Western Ontario Recruiting
London, Ontario, Canada, N6A 5W9
Principal Investigator: Queena Chou, MD         
Sub-Investigator: Yvonne Leong, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Academic Medical Organization of Southwestern Ontario
University of Western Ontario, Canada
Investigators
Principal Investigator: Queena Chou, MD London Health Sciences Centre
  More Information

No publications provided

Responsible Party: Queena Chou, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01843166     History of Changes
Other Study ID Numbers: 102186, 18798
Study First Received: July 8, 2012
Last Updated: April 25, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Pessary
Patient Satisfaction
Estrogen Cream

Additional relevant MeSH terms:
Communicable Diseases
Infection
Urinary Tract Infections
Urologic Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014