Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-22 @ 3:02 AM
Study NCT ID:
NCT02113969
Status:
UNKNOWN
Last Update Posted:
2014-11-18
First Post:
2014-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol
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': 'D010570', 'term': 'Pessaries'}], 'ancestors': [{'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 294}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-17', 'studyFirstSubmitDate': '2014-04-09', 'studyFirstSubmitQcDate': '2014-04-10', 'lastUpdatePostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life changes in pessary users for symptomatic Pelvic Organs Prolapse', 'timeFrame': '6 months and 12 months', 'description': 'At baseline, 6 and 12 month the Chilean Version of the P-QoL survey will be applied to describe the QoL changes'}, {'measure': 'Pelvic Floor Disorders symptoms changes in pessary users for symptomatic Pelvic Organs Prolapse', 'timeFrame': '6 months and 12 months', 'description': 'At baseline, 6 and 12 month the Chilean Version of the Pelvic Distress Inventory - 20 (PDFI-20) survey will be applied to describe the symptoms changes'}, {'measure': 'Sexual response changes in pessary sexually active women users for symptomatic Pelvic Organs Prolapse', 'timeFrame': '6 months and 12 months', 'description': 'At baseline, 6 and 12 month the Chilean Version of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) survey will be applied to describe the Sexually response changes'}, {'measure': 'Subjective impression of improvement after pessary use for symptomatic Pelvic Organs Prolapse', 'timeFrame': '6 months and 12 months', 'description': 'At baseline, 6 and 12 month the Patient Global Impression of Improvement (PGI-I) survey will be applied to describe the subjective improvement'}, {'measure': 'Successful usage of pessary', 'timeFrame': '12 months', 'description': 'If an enrolled patients is still using the pessary as the treatment for the pelvic organ prolapse will be considered as "successful".\n\nRisk factors for unsuccessful pessary used will be measure using baseline characteristics.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pelvic Organ Prolapse', 'Quality of Life', 'Symptoms', 'Pessary', 'Treatment'], 'conditions': ['Pelvic Organ Prolapse', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '38765524', 'type': 'DERIVED', 'citation': 'Arellano M, Santis-Moya F, Maluenda A, Pattillo A, Blumel B, Pohlhammer D, Gonzalez S, Pizarro-Berdichevsky J. Prevalence of colorectal symptoms and anal incontinence in patients with pelvic organ prolapse attended at an outpatient urogynecology service. Rev Bras Ginecol Obstet. 2024 Mar 15;46:e-rbgo10. doi: 10.61622/rbgo/2024AO10. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': "Genital prolapse is a common condition (up 20%), affecting the quality of life. Treatment can be surgical or conservative using vaginal pessaries. These devices are introduced into the vagina aiming to reduces the prolapse.\n\nPessaries have shown effectiveness in improving symptoms and quality of life. There are no randomized studies comparing them with surgery. This study design would be difficult to perform, because the inclusion criteria for both treatments are different. There are no currently standard protocols for the use of pessaries. This makes harder to widespread the usage of this conservative treatment.\n\nThe aim of the investigators is to identify variables that influence the success of conservative management of genital prolapse at 1 year of follow up. Using these variables and an expert panel opinion the investigators will develop a standardized protocol for pessary management.\n\nChile has a primary gynecological care system based midwives. Therefore having algorithms for pessaries usage becomes relevant. This algorithm can be implemented with basic training. This would increase the respond capacity, by the health care system to this disease, considering the scarce access to surgery.\n\nThe investigators hypothesis is: It is possible to generate a standardized protocol of conservative management of symptomatic genital prolapse in patient's beneficiary of public health system in Santiago, Chile, using pessaries through a prospective cohort study based in the success of these devices with 1 year of follow up, measured with questionnaires of symptoms, quality of life and sexuality"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic Pelvic Organ Prolapse\n* Commitment to attend controls\n* Current negative cervical cytology\n* Informed consent signed\n\nExclusion Criteria:\n\n* Urinary incontinence as the only Pessary Indication\n* Vaginal bleeding of undetermined cause\n* Unable to return to controls'}, 'identificationModule': {'nctId': 'NCT02113969', 'briefTitle': 'Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Servicio de Salud Metropolitano Sur Oriente'}, 'officialTitle': 'Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol', 'orgStudyIdInfo': {'id': 'SA12I2153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaginal Pessary', 'description': 'Pessary users for at least 12 months', 'interventionNames': ['Device: Vaginal Pessary']}], 'interventions': [{'name': 'Vaginal Pessary', 'type': 'DEVICE', 'description': 'Pessary fitting session at recruitment, follow up at 1 week, then monthly to complete 1 year follow up. QoL, symptoms and sexual function Surveys will be conducted at recruitment, 6 and 12 month. The absence of bacterial vaginosis (through study of vaginal discharge and pH) will be checked prior to positioning pessary and then each control. At the end of follow up period the success related variables will be determine with a statistical model. This information will be analyzed by an expert panel aiming to identify relevant clinical variables not included. This panel will generate a Standardized Management Protocol for symptomatic pelvic organ prolapse using vaginal pessaries.', 'armGroupLabels': ['Vaginal Pessary']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8207257', 'city': 'Santiago', 'state': 'Santiago Metropolitan', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Javier Pizarro, MD', 'role': 'CONTACT', 'email': 'jpizarro@med.puc.cl', 'phone': '216-583-6220'}, {'name': 'Bernardita Blumel, MD', 'role': 'CONTACT', 'email': 'bernarditablumel@gmail.com', 'phone': '56 9 8232 8165'}, {'name': 'Javier Pizarro, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bernardita Blumel, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Silvana Gonzalez, Midwife', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rodrigo Cuevas, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alejandro Pattillo, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marco Arellano, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rodrigo Pineda, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Victor Miranda, Md, MsC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Oslando Padilla, MsC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Howard B Goldman, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Unidad de Uroginecologia, Complejo Asistencial Dr. Sotero del Rio', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'centralContacts': [{'name': 'Javier Pizarro, MD', 'role': 'CONTACT', 'email': 'jpizarro@med.puc.cl', 'phone': '216 583-6220'}, {'name': 'Bernardita Blumel, MD', 'role': 'CONTACT', 'email': 'bernarditablumel@gmail.com', 'phone': '56 9 82328165'}], 'overallOfficials': [{'name': 'Javier Pizarro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Complejo Asistencial Dr. Sotero del Rio'}, {'name': 'Bernardita Blumel, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Complejo Asistencial Dr. Sotero del Rio'}, {'name': 'Silvana Gonzalez, Midwife', 'role': 'STUDY_CHAIR', 'affiliation': 'Complejo Asistencial Dr. Sotero del Rio'}, {'name': 'Alejandro Pattillo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'H. Dr. Sotero del Rio; Pontificia Universidad Católica de Chile'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Servicio de Salud Metropolitano Sur Oriente', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Pontificia Universidad Catolica de Chile', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}