Vaginal Estrogen With Pessary Treatment

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01843166

Collaborator

Academic Medical Organization of Southwestern Ontario (Other), University of Western Ontario, Canada (Other)

150

Enrollment

Location

Arms

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Vaginal Infection Urinary Tract Infection Quality of Life	Drug: Premarin vaginal cream Drug: Placebo cream	N/A

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:

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 Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Vaginal infections [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.

Secondary Outcome Measures

Frequency of urinary tract infection [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 [60 weeks]
Patients will complete validated questionnaires to assess quality of life with respect to urinary, bowel, and sexual function.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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