Completed

Use of Vaginal Estrogen With Pessary Treatment of Pelvic Organ Prolapse and Urinary Incontinence

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Premarin vaginal cream

+ Placebo cream

Drug
Who is being recruted

Treatment Adherence and Compliance+12

+ Urogenital Diseases

+ Genital Diseases

From 18 to 100 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Last updated: November 6, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Last updated: November 6, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Treatment Adherence and ComplianceUrogenital DiseasesGenital DiseasesBehaviorFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleInfectionsUrologic DiseasesVaginal DiseasesHealth BehaviorFemale Urogenital DiseasesMale Urogenital DiseasesUrinary Tract InfectionsVaginitisPatient Satisfaction

Criteria

1 inclusion criteria required to participate
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

7 exclusion criteria prevent from participating
are currently using oral estrogen

are not competent to consent

have a contraindication to the use of estrogen cream or products

have a past medical history of thromboembolism, myocardial infarction and stroke or are pregnant

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
These patients will utilize a pessary and be given instructions for use and prescription for Premarin vaginal cream 2g at bedtime twice weekly.

Group II

Placebo
These patients will utilize a pessary with an inactive placebo cream.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

London Health Sciences Centre, University of Western Ontario

London, CanadaOpen London Health Sciences Centre, University of Western Ontario in Google Maps
CompletedOne Study Center