Ignite Creation Date:
2025-12-24 @ 4:00 PM
Ignite Modification Date:
2025-12-31 @ 12:19 PM
Study NCT ID:
NCT01843166
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2012-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Estrogen With Pessary Treatment
Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Organization:
Study Overview
Official Title:
Use of Vaginal Estrogen With Pessary Treatment of Pelvic Organ Prolapse and Urinary Incontinence
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 18798 | OTHER | HSREB | View |