Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 2:30 PM
Study NCT ID:
NCT00952406
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
2009-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059952', 'term': 'Pelvic Floor Disorders'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'No Biospecimens are to be retained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 877}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-10', 'studyFirstSubmitDate': '2009-08-04', 'studyFirstSubmitQcDate': '2009-08-05', 'lastUpdatePostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure for this study is the creation of a valid and reliable new measure of sexual health in women with pelvic floor disorders.', 'timeFrame': '3-5 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pelvic Floor Disorders', 'Sexual Function', 'Incontinence', 'Pelvic Organ Prolapse'], 'conditions': ['Pelvic Floor Disorders', 'Sexual Dysfunction', 'Incontinence', 'Pelvic Organ Prolapse']}, 'referencesModule': {'references': [{'pmid': '23632797', 'type': 'BACKGROUND', 'citation': 'Rogers RG, Espuna Pons ME. The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR). Int Urogynecol J. 2013 Jul;24(7):1063-4. doi: 10.1007/s00192-012-1952-3. Epub 2013 Apr 30. No abstract available.'}, {'pmid': '26142348', 'type': 'RESULT', 'citation': 'Kanter G, Jeppson PC, McGuire BL, Rogers RG. Perineorrhaphy: commonly performed yet poorly understood. A survey of surgeons. Int Urogynecol J. 2015 Dec;26(12):1797-801. doi: 10.1007/s00192-015-2762-1. Epub 2015 Jul 4.'}, {'pmid': '23632799', 'type': 'RESULT', 'citation': 'Rockwood TH, Constantine ML, Adegoke O, Rogers RG, McDermott E, Davila GW, Domoney C, Jha S, Kammerer-Doak D, Lukacz ES, Parekh M, Pauls R, Pitkin J, Reid F, Ridgeway B, Thakar R, Sand PK, Sutherland SE, Espuna-Pons M. The PISQ-IR: considerations in scale scoring and development. Int Urogynecol J. 2013 Jul;24(7):1105-22. doi: 10.1007/s00192-012-2037-z. Epub 2013 Apr 30.'}, {'pmid': '23632798', 'type': 'RESULT', 'citation': 'Rogers RG, Rockwood TH, Constantine ML, Thakar R, Kammerer-Doak DN, Pauls RN, Parekh M, Ridgeway B, Jha S, Pitkin J, Reid F, Sutherland SE, Lukacz ES, Domoney C, Sand P, Davila GW, Espuna Pons ME. A new measure of sexual function in women with pelvic floor disorders (PFD): the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). Int Urogynecol J. 2013 Jul;24(7):1091-103. doi: 10.1007/s00192-012-2020-8. Epub 2013 Apr 30.'}, {'pmid': '25392184', 'type': 'RESULT', 'citation': 'Pauls RN, Rogers RG, Parekh M, Pitkin J, Kammerer-Doak D, Sand P. Sexual function in women with anal incontinence using a new instrument: the PISQ-IR. Int Urogynecol J. 2015 May;26(5):657-63. doi: 10.1007/s00192-014-2563-y. Epub 2014 Nov 13.'}]}, 'descriptionModule': {'briefSummary': 'Study Aims:\n\n1. To validate a new measure of sexual function and activity in women with PFDs;\n2. To establish the responsiveness to change of the new measure.\n\nThe investigators hypothesis is that the investigators can create a new questionnaire that accurately measures sexual health in women with pelvic floor disorders that improves on the already published questionnaires.', 'detailedDescription': '600 women presenting for care to urogynecology clinics in the United States and England will be recruited to participate. They will give data regarding their physical exam, including measurements by the Pelvic Organ Prolapse Quantification exam and medical and surgical history. In addition, they will complete validated questionnaires including the Incontinence Severity Index, the Pelvic Floor Distress Inventory (short form) and question # 35 from the Epidemiology of Prolapse and Incontinence Questionnaire. All women will also complete two sexual health questionnaires; the Female Sexual Function Index and the Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire (Revised). Women will receive standard care for their pelvic floor disorders. They will then be recontacted to repeat the same set of questionnaires to determine the responsiveness of the new measure. Reliability of the questionnaire will be measured by having a subset of women complete the questionnaire twice; a factor analysis will be performed to determine the underlying factor structure. Responses to the other QOL measures will be compared to those to the new instrument to establish validity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Goal to enroll approximately 800 women so that 600 surveys are available for evaluation of the sexual health of women with pelvic floor disorders presenting for urogynecological care in the United States or England', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria for patients include age over 18 years.\n* Not pregnant.\n* Able to read/write and understand English.\n* And, because this is a project to validate a measure of female sexual function, all subjects will be women.\n* All women will be seeking care for PFD including urinary and anal incontinence and POP. Since data collection will primarily be by mail\n* Women must have a stable and current address.\n\nExclusion Criteria:\n\n* Women under the age of 18.\n* Are pregnant or who are unable to read/write or understand English will not be eligible for participation.\n* In addition, women with a diagnosis of vulvodynia, painful bladder syndrome, or chronic pelvic pain (defined as pelvic pain for greater than 6 months) as determined by the consenting physician will be excluded.\n* Since this is a study to evaluate both sexual activity status as well as sexual function, women need not be sexually active to participate.'}, 'identificationModule': {'nctId': 'NCT00952406', 'briefTitle': 'A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders', 'organization': {'class': 'OTHER', 'fullName': 'International Urogynecological Society'}, 'officialTitle': 'A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders', 'orgStudyIdInfo': {'id': 'IUGA -1 - 09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Survey of Women PFDs', 'description': 'Women with PFDs', 'interventionNames': ['Other: Survey']}], 'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'This is a study to develop a survey for sexual health in women with pelvic floor dysfunction', 'armGroupLabels': ['Survey of Women PFDs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "UCSD women's Pelvic Medicine Center", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '60611', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinburg School of Medicine', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '55441', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'MetroUrology', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': "Women's Pelvic Speciality Care PC", 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '45069', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Center for Female Sexual Health', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Lerner College of Medicine', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '52803', 'city': 'Zanesville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Genesis Health System', 'geoPoint': {'lat': 39.94035, 'lon': -82.01319}}, {'zip': '17882', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Health Systems', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea and Westminster Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'The Warrell Unit, Whitworth Park', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Northwick Park and St Marks Hospital', 'geoPoint': {'lat': 51.53174, 'lon': -0.26856}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Royal Hallamshire Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Surrey', 'country': 'United Kingdom', 'facility': 'Mayday University Hospital'}], 'overallOfficials': [{'name': 'Rebecca G Rogers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico Health Sciences Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Urogynecological Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rebecca G Rogers', 'investigatorAffiliation': 'International Urogynecological Society'}}}}