Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-30 @ 11:55 PM
Study NCT ID:
NCT05072158
Status:
TERMINATED
Last Update Posted:
2024-01-12
First Post:
2021-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pelvic Floor Disorders Among Sexual Minoritized Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI has confirmed this is not a clinical trial and was entered in error in the system.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2021-08-18', 'studyFirstSubmitQcDate': '2021-09-27', 'lastUpdatePostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative impact of pelvic floor disorders on sexual function', 'timeFrame': '6 months', 'description': 'We will assess the impact of pelvic floor disorders with qualitative analysis and informational interviews'}], 'secondaryOutcomes': [{'measure': 'Qualitative inclusivity of sexual function questionnaires', 'timeFrame': '6 months', 'description': 'We will examine this with guided focus groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sexual Function Disturbances', 'Pelvic Organ Prolapse', 'Urinary Incontinence', 'Fecal Incontinence']}, 'descriptionModule': {'briefSummary': 'The investigators aim to perform cognitive interviews to assess how pelvic floor disorders impact sexual functioning in women who have sex with women (WSW). As a secondary objective there will be cognitive interviews to assess perceptions of sexual function questionnaires such as Female Sexual Function Index (FSFI) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-IUGA Revised (PISQ-IR) in WSW.', 'detailedDescription': 'There is a paucity of data regarding care of women who have sex with women (WSW). While some cohort studies are being performed in general gynecology, no studies document the reasons as to why WSW seek urogynecological care, or how pelvic floor disorders (PFDs) affect sexual function in this population. Another detrimental gap in current knowledge and a barrier to care for WSW is the lack of understanding of what would drive WSW to seek care, if there are special considerations for care, or if the commonly used condition specific questionnaires adequately reflect their concerns. The Investigators aim to perform qualitative interviews to understand how PFDs affect sexual function, and if commonly utilized sexual function questionnaires are inclusive to WSW.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'New patients over the age of 18 who present to urogynecology office or contact the research team with interest in participating in the study who self-identify as women who have sex with women. This may include but is not limited to: lesbian and bisexual women.', 'genderDescription': 'This trial is open only to wmen', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* WSW who have a PFD (pelvic organ prolapse, urinary incontinence, fecal incontinence)\n* Age \\>18\n* Able to provide consent\n* Able to read/write in English\n\nExclusion Criteria:\n\n* WSW who have not been sexually active in the past 6 months\n* Incarcerated patients\n* Pregnant or lactating patients\n* Unable to consent with study procedures or guided discussions\n* Unable to speak English\n* No sexual activity in the past 6 months'}, 'identificationModule': {'nctId': 'NCT05072158', 'acronym': 'PRIDE', 'briefTitle': 'Pelvic Floor Disorders Among Sexual Minoritized Women', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Pelvic Floor Disorders Among Sexual Minoritized Women', 'orgStudyIdInfo': {'id': '21-196'}}, 'armsInterventionsModule': {'interventions': [{'name': 'None, this is an observational study', 'type': 'OTHER', 'description': 'This is a qualitative study, we will be asking for patient experiences with PFDs and the impact on their sexual function.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Sierra Jansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'Albany Medical College', 'class': 'OTHER'}, {'name': 'University of Texas at Austin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}