Vaginal Estrogen With Pessary Treatment

Not Applicable

Completed

• Conditions: Vaginal Infection; Urinary Tract Infection; Quality of Life
• Interventions: Drug: Premarin vaginal cream; Drug: Placebo cream

• Registration Number: NCT01843166
• Lead Sponsor: Lawson Health Research Institute

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.

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-08
• Study First Submitted QC: 2013-04-25
• Study First Posted: 2013-04-30
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-02
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Premarin vaginal cream	These patients will utilize a pessary and be given instructions for use and prescription for Premarin vaginal cream 2g at bedtime twice weekly.
Control group	Placebo cream	These patients will utilize a pessary with an inactive placebo cream.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

London Health Sciences Centre, University of Western Ontario; 🇨🇦 London, Ontario, Canada