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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-02', 'studyFirstSubmitDate': '2012-07-08', 'studyFirstSubmitQcDate': '2013-04-25', 'lastUpdatePostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal infections', 'timeFrame': '60 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Frequency of urinary tract infection', 'timeFrame': '60 weeks', 'description': 'Urine samples at each follow-up visit will be used to detect the presence or absence of a urinary tract infection.'}, {'measure': 'Quality of life', 'timeFrame': '60 weeks', 'description': 'Patients will complete validated questionnaires to assess quality of life with respect to urinary, bowel, and sexual function.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pessary', 'Patient Satisfaction', 'Estrogen Cream'], 'conditions': ['Vaginal Infection', 'Urinary Tract Infection', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '33207004', 'type': 'DERIVED', 'citation': 'Bugge C, Adams EJ, Gopinath D, Stewart F, Dembinsky M, Sobiesuo P, Kearney R. Pessaries (mechanical devices) for managing pelvic organ prolapse in women. Cochrane Database Syst Rev. 2020 Nov 18;11(11):CD004010. doi: 10.1002/14651858.CD004010.pub4.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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\n\nPatients who agree to participate in the study will be given a consent form\n\nPatients in the study and thus those who have opted for pessary use will be randomized between two groups:\n\n1. Treatment group - will be given instructions for use and prescription for Premarin vaginal cream 2g at bedtime twice weekly\n2. Control group - will utilize pessary with an inactive placebo cream\n\nBoth the patient and the investigators will be blinded to patient treatment.\n\nIf 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.\n\nFor 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.\n\nPatients 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.\n\nPatients will be assessed for satisfaction and complications 6 wks, 18 wks, 36 wks and 60 wks after the successful fitting.\n\nTo 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.\n\nAt 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* have a contraindication to the use of estrogen cream or products\n* have any allergy to the use of estrogen cream or products\n* have a past medical or family history of breast cancer\n* have a past medical history of thromboembolism, myocardial infarction and stroke or are pregnant\n* have previously used Premarin vaginal cream\n* are currently using oral estrogen\n* are not competent to consent'}, 'identificationModule': {'nctId': 'NCT01843166', 'briefTitle': 'Vaginal Estrogen With Pessary Treatment', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Use of Vaginal Estrogen With Pessary Treatment of Pelvic Organ Prolapse and Urinary Incontinence', 'orgStudyIdInfo': {'id': '102186'}, 'secondaryIdInfos': [{'id': '18798', 'type': 'OTHER', 'domain': 'HSREB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment group', 'description': 'These patients will utilize a pessary and be given instructions for use and prescription for Premarin vaginal cream 2g at bedtime twice weekly.', 'interventionNames': ['Drug: Premarin vaginal cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'These patients will utilize a pessary with an inactive placebo cream.', 'interventionNames': ['Drug: Placebo cream']}], 'interventions': [{'name': 'Premarin vaginal cream', 'type': 'DRUG', 'description': '2g at bedtime twice weekly', 'armGroupLabels': ['Treatment group']}, {'name': 'Placebo cream', 'type': 'DRUG', 'description': '2g at bedtime twice weekly', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre, University of Western Ontario', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Queena Chou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'collaborators': [{'name': 'Academic Medical Organization of Southwestern Ontario', 'class': 'OTHER'}, {'name': 'University of Western Ontario, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}