Vaginal Estrogen With Pessary Treatment
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|ClinicalTrials.gov Identifier: NCT01843166|
Recruitment Status : Completed
First Posted : April 30, 2013
Last Update Posted : November 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Vaginal Infection Urinary Tract Infection Quality of Life||Drug: Premarin vaginal cream Drug: Placebo cream||Not Applicable|
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:
- Treatment group - will be given instructions for use and prescription for Premarin vaginal cream 2g at bedtime twice weekly
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Use of Vaginal Estrogen With Pessary Treatment of Pelvic Organ Prolapse and Urinary Incontinence|
|Actual Study Start Date :||July 2012|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
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
- Vaginal infections [ Time Frame: 60 weeks ]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.
- Frequency of urinary tract infection [ Time Frame: 60 weeks ]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 ]Patients will complete validated questionnaires to assess quality of life with respect to urinary, bowel, and sexual function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843166
|London Health Sciences Centre, University of Western Ontario|
|London, Ontario, Canada, N6A 5W9|
|Principal Investigator:||Queena Chou, MD||London Health Sciences Centre|