Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT06021769
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2023-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pessary Experience Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-26', 'studyFirstSubmitDate': '2023-08-26', 'studyFirstSubmitQcDate': '2023-08-26', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative analysis', 'timeFrame': 'up to 1 year after pessary fitting', 'description': 'Perform a patient-centered, qualitative analysis of pessary discontinuation'}, {'measure': 'Pelvic Floor symptom improvement as related to quality of life', 'timeFrame': 'up to 1 year after pessary fitting', 'description': 'Assess changes in pelvic floor symptoms and quality of life before and after pessary use as measured by validated questionnaires'}, {'measure': 'Discontinuation of pessaries', 'timeFrame': 'up to 1 year after pessary fitting', 'description': 'Rates of discontinuation at 1 year'}, {'measure': 'Why do women discontinue using pessaries?', 'timeFrame': 'up to 1 year after pessary fitting', 'description': 'Factors significantly associated with discontinuation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pessary'], 'conditions': ['Pelvic Organ Prolapse', 'Stress Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '28815277', 'type': 'BACKGROUND', 'citation': 'Yimphong T, Temtanakitpaisan T, Buppasiri P, Chongsomchai C, Kanchaiyaphum S. Discontinuation rate and adverse events after 1 year of vaginal pessary use in women with pelvic organ prolapse. Int Urogynecol J. 2018 Aug;29(8):1123-1128. doi: 10.1007/s00192-017-3445-x. Epub 2017 Aug 16.'}, {'pmid': '27525693', 'type': 'BACKGROUND', 'citation': 'Panman CM, Wiegersma M, Kollen BJ, Burger H, Berger MY, Dekker JH. Predictors of unsuccessful pessary fitting in women with prolapse: a cross-sectional study in general practice. Int Urogynecol J. 2017 Feb;28(2):307-313. doi: 10.1007/s00192-016-3107-4. Epub 2016 Aug 15.'}, {'pmid': '32447418', 'type': 'BACKGROUND', 'citation': 'Umachanger JK, Marcussen ML, Boggild H, Kjaergaard N, Glavind K. First-line treatment of pelvic organ prolapse and discontinuation of pessary treatment. Int Urogynecol J. 2020 Sep;31(9):1813-1819. doi: 10.1007/s00192-020-04338-w. Epub 2020 May 24.'}]}, 'descriptionModule': {'briefSummary': 'Pessaries are silicone devices inserted into the vagina for treatment of pelvic organ prolapse or stress urinary incontinence. They are adequate treatment options for patients who are poor surgical candidates, those who decline surgical intervention, or as a temporizing measure in those ultimately planning surgery. Most studies suggest that about 75% of patients are able to be successfully fit with a pessary, but about 50% discontinue pessary use within 12 months of initiation. The purpose of this study is to determine why pessaries are discontinued.', 'detailedDescription': "Pessaries are silicone devices inserted into the vagina for treatment of pelvic organ prolapse or stress urinary incontinence. They are adequate treatment options for patients who are poor surgical candidates, those who decline surgical intervention, or as a temporizing measure in those ultimately planning surgery. Most studies suggest that about 75% of patients are able to be successfully fit with a pessary, but about 50% discontinue pessary use within 12 months of initiation.\n\nResearch concerning pessary discontinuation is currently focused on identifying factors that will predict outcomes of pessary use. It is generally agreed upon that pessaries are one of the favored option to conservatively treat pelvic organ prolapse or stress urinary incontinence, but there is not sufficient consensus on the rate of discontinuation, factors leading to discontinuation, and patient satisfaction.\n\nMost studies recorded reasons for discontinuation and any adverse events. Patients' reasons for discontinuation of pessary use included frequent expulsion, difficulty removing pessary, new or worsening urinary incontinence, vaginal erosion, and pain/discomfort. Significant side effects or adverse events included vaginal discharge and erosion.\n\nSeveral studies focused on anatomic and medical variables that were correlated to pessary discontinuation. A univariate analysis of factors contributing to discontinuation conducted by Yimphong et al.1 found that higher BMI and history of pelvic surgery were significant in predicting discontinuation. Similarly, Panman2 et al. conducted a multivariate analysis that found higher BMI was a significant factor. Panman et al. also found that both younger age and weaker pelvic floor muscles were predictors for discontinuation. The former finding is further supported by Umchanger et al., which cited that 33% of patients who discontinued pessary use within three months were generally less than 65 years. Umchanger et al. hypothesized that despite data suggesting that pessaries are as effective as surgery, younger patients may maintain the misconception that pessaries are not as effective.\n\nDespite the data suggesting contributing factors such as BMI and age, none of the reviewed studies captured the qualitative reasoning behind patients' decisions. Only a few of the studies investigate patients' satisfaction with pessary use, quality of life, or opinion on their treatment.\n\nPessary use has been correlated to a wide variety of factors, such as a patient's medical history, anatomic characteristics, beliefs about pessary use, and personal satisfaction with treatment. Based on this review, a qualitative analysis of patient experience and priorities as they decide to continue or discontinue pessary use would be incredibly helpful for counseling and educating future patients when they are making treatment decisions about pessaries."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women in the area surrounding the University of Virginia who have stress urinary incontinences or pelvic organ prolapse.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English-speaking women aged 18 years or older\n* Choosing to undergo a pessary fitting for symptomatic pelvic organ prolapse and/or stress urinary incontinence at the University of Virginia Pelvic Medicine and Reconstructive Surgery clinic\n* Willingness and ability to comply with scheduled visits and study procedures.\n* Successful pessary fitting\n\nExclusion Criteria:\n\n* Pregnant women\n* Prisoners\n* Cognitively impaired\n* Non-English speaking subjects\n* Patients who cannot comply with pessary check visits\n* Active vaginal infection\n* Vaginal malignancy\n* Genitourinary tract fistula'}, 'identificationModule': {'nctId': 'NCT06021769', 'briefTitle': 'Pessary Experience Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Longitudinal Assessment of Pessary Experience', 'orgStudyIdInfo': {'id': 'HSR220160'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women being fitted with pessaries', 'description': 'Women being fitted with pessaries as standard of care will be eligible to participate. They will be asked to complete a recorded verbal interview and written questionnaires the day they have their pessaries fitted and at their follow-up clinic appointments at 4-6 weeks, 3 months, 6 months, and 12 months. Another recorded video interview will be completed at the 12 month appointment.', 'interventionNames': ['Other: Observational only']}], 'interventions': [{'name': 'Observational only', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Women being fitted with pessaries']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Monique Vaughan, MD', 'role': 'CONTACT', 'email': 'mv4w@UVAHEALTH.ORG', 'phone': '4349261955'}, {'name': 'Monique Vaughan, MD', 'role': 'CONTACT', 'email': 'mv4w@UVAHEALTH.ORG', 'phone': '4349242103'}], 'overallOfficials': [{'name': 'Monique Vaughan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Monique Vaughan, MD', 'investigatorAffiliation': 'University of Virginia'}}}}