[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549300":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":39,"armGroups":49,"interventions":62,"overallOfficials":71,"centralContacts":75,"locations":81,"responsibleParty":97,"collaborators":99,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":39,"eligibilityCriteria":123,"healthyVolunteers":119,"sex":124,"minAge":125,"maxAge":39,"enrollmentInfo":126,"targetDuration":39,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":39,"overallStatus":135,"whyStopped":39,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Continued usage with satisfaction","Continued usage of the pessary and have very much or much improvement in the patient impression of improvement (PGI-I) questionnaire at 1 year.","12 months after pessary fitting.",[14,18,21,24,27,30,33,36],{"measure":15,"description":16,"timeFrame":17},"Knowledge of pessary","Self-rated score from 0 to 10 points (higher scores mean a better outcome).","Baseline and at pessary fitting.",{"measure":19,"description":16,"timeFrame":20},"Willingness to treatment","Baseline, at pessary fitting, and 3 and 12 months after successful pessary fitting.",{"measure":22,"description":23,"timeFrame":17},"Anxiety about pessary use","7-item generalized anxiety disorder questionnaire (GAD-7) (the range of scores is 0-21, and higher scores mean a worse outcome), and self-rated score of sleep quality from 0 to 10 points (higher scores mean a better outcome).",{"measure":25,"description":16,"timeFrame":26},"Ability to self-manage","3 and 12 months after successful pessary fitting.",{"measure":28,"description":29,"timeFrame":26},"Treatment-related symptoms and complications","Self report and physical examination.",{"measure":31,"description":32,"timeFrame":26},"Improvement in symptoms","Pelvic floor impact questionnaire-7 (PFIQ-7) (the range of scores is 0-300, and higher scores mean a worse outcome)",{"measure":34,"description":35,"timeFrame":26},"Improvement in quality of life","Pelvic floor distress inventory-20 (PFDI-20) (the range of scores is 0-300, and higher scores mean a worse outcome)",{"measure":37,"description":38,"timeFrame":26},"Improvement in sexual activity","The pelvic organ prolapse\u002Furinary incontinence sexual questionnaire short form (PISQ-12) (the range of scores is 0-48, and higher scores mean a worse outcome)",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":45,"maskingDescription":39,"whoMasked":46},"DOUBLE",[47,48],"INVESTIGATOR","OUTCOMES_ASSESSOR",[50,57],{"label":51,"type":52,"description":53,"interventionNames":54},"the conventional education plus video education group","EXPERIMENTAL","Watch video as well as receive conventional guidance.",[55,56],"Other: video education","Other: conventional education",{"label":58,"type":59,"description":60,"interventionNames":61},"the conventional education group","ACTIVE_COMPARATOR","Receive conventional guidance.",[56],[63,67],{"type":6,"name":64,"description":65,"armGroupLabels":66,"otherNames":39},"video education","A re-watchable video provided before pessary fitting which mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy.",[51],{"type":6,"name":68,"description":69,"armGroupLabels":70,"otherNames":39},"conventional education","Conventional verbal\u002Fpaper instruction and counseling from a specialized doctor or nurse before pessary fitting.",[58,51],[72],{"name":73,"affiliation":5,"role":74},"Lan Zhu, MD","PRINCIPAL_INVESTIGATOR",[76],{"name":77,"role":78,"phone":79,"phoneExt":39,"email":80},"Ying Zhou, MD","CONTACT","+8613681253992","shellypumch@163.com",[82],{"facility":5,"status":39,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Beijing","Beijing Municipality","100730","China","CN",{"type":89,"coordinates":90},"Point",[91,92],116.39723,39.9075,{"lat":92,"lon":91},[95,96],{"name":77,"role":78,"phone":79,"phoneExt":39,"email":80},{"name":73,"role":74,"phone":39,"phoneExt":39,"email":39},{"type":98,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[100,102,104,106,108,110,113,115],{"name":101,"class":6},"Peking University People's Hospital",{"name":103,"class":6},"Shandong University",{"name":105,"class":6},"Tongji Hospital",{"name":107,"class":6},"Third Military Medical University",{"name":109,"class":6},"Changsha Hospital for Maternal and Child Health Care",{"name":111,"class":112},"Hangzhou Women's Hospital","UNKNOWN",{"name":114,"class":6},"Shenzhen People's Hospital",{"name":116,"class":6},"Foshan Women's and Children's Hospital","100549300","patient-education-in-the-clinical-management-of-pessary-100549300",false,"NCT06432218","Patient Education in the Clinical Management of Pessary","A Randomized Controlled Trial of the Effectiveness of Patient Education in the Clinical Management of Pessary","Inclusion Criteria:\n\n* Symptomatic pelvic organ prolapse of stage II\\~IV\n* Ability to participate in clinical trial and follow-up\n* The patient and family understand the study, are willing to participate in the 1-year study, and provide written informed consent\n\nExclusion Criteria:\n\n* Acute phase of infection of the internal and\u002For external genital tracts\n* Genital fistula\n* Suspected or untreated lower genital tract tumors\n* Abnormally elevated intra-abdominal pressure (e.g., ascites, tumors)\n* Life expectancy less than 1 year\n* Cognitive or language communication disorders\n* Unable to watch video (e.g., blindness)","FEMALE","18 Years",{"count":127,"type":128},280,"ESTIMATED","INTERVENTIONAL",[131],"NA","This study is a prospective, randomized, controlled, single-blinded, multi-center clinical trial. Symptomatic patients with pelvic organ prolapse (POP) stage II, III or IV arranged to undergo pessary treatment will be randomized into either the experimental group or the control group. All patients will receive conventional verbal\u002Fpaper instruction and counseling from a specialized doctor or nurse before pessary fitting, and the experimental group will receive additional patient education in the form of a re-watchable video. The video mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy. All patients will receive regular pessary fitting and be followed up for 1 year. Self-assessment questionnaires will be used to assess the patients' willingness to pessary treatment, anxiety status, treatment satisfaction and efficacy, and to assess the patients' self-management, complications and treatment adherence. Then the differences between the two groups will be compared.",[134],"Pelvic Organ Prolapse","NOT_YET_RECRUITING","2024-05-22",{"date":138,"type":139},"2024-05-29","ACTUAL",{"date":141,"type":128},"2024-06",{"date":143,"type":128},"2026-11",{"name":5,"class":6},1]