Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT04890951
Status:
UNKNOWN
Last Update Posted:
2021-06-03
First Post:
2021-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007044', 'term': 'Hysterectomy'}], 'ancestors': [{'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 321}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-31', 'studyFirstSubmitDate': '2021-05-05', 'studyFirstSubmitQcDate': '2021-05-12', 'lastUpdatePostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anatomic failure to correct apical POP', 'timeFrame': '1 year', 'description': 'Descent of the apex (POP-Q point C) equal to or beyond one half of the total vaginal length'}], 'secondaryOutcomes': [{'measure': 'Overall failure to correct POP', 'timeFrame': '1 year', 'description': 'POP-Q stage ≥2 in any compartment, or re-treatment of POP with physiotherapy, pessary, or repeat surgery'}, {'measure': 'Subjective failure to correct POP', 'timeFrame': '6 weeks; 1 year', 'description': 'Patient report of bulge symptoms at 6 weeks or 1 year, using one item on the PFDI-20: "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?"'}, {'measure': 'Length of surgery (minutes)', 'timeFrame': 'Peri-operative'}, {'measure': 'Estimated blood loss during surgery >500 mL', 'timeFrame': 'Peri-operative'}, {'measure': 'Procedural complications', 'timeFrame': 'Peri-operative', 'description': 'E.g., peri-operative blood transfusion, visceral injury'}, {'measure': 'Post-operative infection', 'timeFrame': 'Peri-operative', 'description': 'E.g., abscess, urinary tract infection'}, {'measure': 'Opioid use in-hospital', 'timeFrame': 'Peri-operative', 'description': 'Measured by Morphine milliequivalent (mEq)'}, {'measure': 'Resumption of spontaneous voiding (days)', 'timeFrame': 'Peri-operative'}, {'measure': 'Length of post-operative stay (days)', 'timeFrame': 'Peri-operative'}, {'measure': 'PROM: Total Pelvic Floor Impact Questionnaire-7 (PFIQ-7) score', 'timeFrame': '6 weeks; 1 year', 'description': 'Change from baseline'}, {'measure': 'PROM: Total POP Incontinence Sexual Questionnaire Revised (PISQ-IR) score', 'timeFrame': '6 weeks; 1 year', 'description': 'Change from baseline'}, {'measure': 'PROM: Total Pelvic Floor Distress Inventory-20 (PFDI-20) score', 'timeFrame': '6 weeks; 1 year', 'description': 'Change from baseline'}, {'measure': 'Presentation at the emergency department', 'timeFrame': '30 days (any health complaint); 1 year (pelvic floor-related complaint)'}, {'measure': 'Hospital readmission', 'timeFrame': '30 days (any health complaint); 1 year (pelvic floor-related complaint)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pelvic Organ Prolapse', 'Gynecologic Surgery', 'Female', 'Epidemiology'], 'conditions': ['Pelvic Organ Prolapse']}, 'referencesModule': {'references': [{'pmid': '34607873', 'type': 'DERIVED', 'citation': "Scime NV, Ramage K, Brennand EA; Calgary Women's Pelvic Health Research Group. Protocol for a prospective multisite cohort study investigating hysterectomy versus uterine preservation for pelvic organ prolapse surgery: the HUPPS study. BMJ Open. 2021 Oct 4;11(10):e053679. doi: 10.1136/bmjopen-2021-053679."}]}, 'descriptionModule': {'briefSummary': 'Pelvic organ prolapse (POP) is the descent of pelvic organs into the vagina resulting in bulge symptoms and occurs in approximately 50% of women. Almost 20% of women will elect surgical correction of this condition by age 85. Removal of the uterus (hysterectomy) with concomitant vaginal vault suspension is a longstanding practice in POP surgery to address apical (uterine) prolapse. Yet, contemporary evidence on the merits of this approach relative to preservation of the uterus through suspension is needed to better inform surgical decision-making by patients and their healthcare providers. The objective of this trial is to evaluate POP-specific health outcomes and service utilization of women electing uterine suspension compared to those electing hysterectomy and vaginal vault suspension for POP surgery up to 1-year post-surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women seeking surgical correction of POP at one of the study sites.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have diagnosed POP of stage ≥2 using the globally recognized Pelvic Organ Prolapse-Quantification System (POP-Q)\n* Elect surgical management of POP\n* Demonstrate presence of apical prolapse on clinical exam deemed to require either a hysterectomy and concomitant vaginal vault suspension or uterine suspension to properly address their POP during surgical correction\n* Desire no further pregnancy\n* Can communicate in English\n* Are ≥18 years in age\n\nExclusion Criteria:\n\n* Prior hysterectomy'}, 'identificationModule': {'nctId': 'NCT04890951', 'acronym': 'HUPPS', 'briefTitle': 'Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Prospective Multi-site Cohort Study Investigating Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery: The HUPPS Study', 'orgStudyIdInfo': {'id': 'REB19-2134'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Uterine Preservation', 'interventionNames': ['Procedure: Hysteropexy']}, {'label': 'Hysterectomy', 'interventionNames': ['Procedure: Hysterectomy and vaginal vault suspension']}], 'interventions': [{'name': 'Hysteropexy', 'type': 'PROCEDURE', 'description': 'Uterine preservation through suspension', 'armGroupLabels': ['Uterine Preservation']}, {'name': 'Hysterectomy and vaginal vault suspension', 'type': 'PROCEDURE', 'description': 'Uterine removal and sewing the vagina upwards', 'armGroupLabels': ['Hysterectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Natalie Scime, MSc', 'role': 'CONTACT', 'email': 'natalie.scime@ucalgary.ca'}], 'facility': 'Pelvic Floor Clinic', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'centralContacts': [{'name': 'Erin A Brennand, MD', 'role': 'CONTACT', 'email': 'Erin.brennand@albertahealthservices.ca', 'phone': '403-944-1636'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'The MSI Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}