Quality of Life Clinical Trial
Official title:
Use of Vaginal Estrogen With Pessary Treatment of Pelvic Organ Prolapse and Urinary Incontinence
NCT number | NCT01843166 |
Other study ID # | 102186 |
Secondary ID | 18798 |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2012 |
Est. completion date | December 2016 |
Verified date | November 2018 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 100 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre, University of Western Ontario | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute | Academic Medical Organization of Southwestern Ontario, University of Western Ontario, Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vaginal infections | 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. | 60 weeks | |
Secondary | Frequency of urinary tract infection | Urine samples at each follow-up visit will be used to detect the presence or absence of a urinary tract infection. | 60 weeks | |
Secondary | Quality of life | Patients will complete validated questionnaires to assess quality of life with respect to urinary, bowel, and sexual function. | 60 weeks |
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