[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06689891":3,"trial-entities:NCT06689891":106,"trial-summary:NCT06689891":112},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":52,"sex":69,"minimum_age":70,"maximum_age":15,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":80,"locations":83,"central_contacts":93,"overall_officials":103,"references":104,"see_also_links":105},"NCT06689891","2000037163","Video-Based Pelvic Floor Muscle Therapy","Utilizing Remote, Video-Based Pelvic Floor Muscle Therapy: A Feasibility Trial","RECRUITING","2026-12","2026-01","2026-01-16","2025-06-09","Yale University","OTHER",null,"This study is a feasibility, pilot trial of remote, video-based pelvic floor muscle therapy (PFMT) for patients with pelvic floor disorders, including pelvic organ prolapse, urinary incontinence and anorectal dysfunction. PFMT has been shown to improve these symptoms in multiple studies.","This will be a feasibility and acceptability trial of a novel remote, web-accessible PFMT curriculum, designed by pelvic floor physical therapists.\n\nPatients will be expected to complete a 5-10-minute survey at initial enrollment. They will have one in-person session with a pelvic floor therapist prior to starting the 8-week video-based PFMT course. Afterwards, they will have a final in person session with a pelvic floor therapist along with a final set of surveys that should take an estimated 10-15 minutes.\n\nThe primary objective is to the determine the feasibility and accessibility of using a video-based PFMT for patients with pelvic floor dysfunction.\n\nThe secondary objective is to determine whether video-based PFMT can improve symptomatology and quality of life.",[19,20],"Pelvic Floor Disorder","Pelvic Floor Muscle Exercise",[],"INTERVENTIONAL","DEVICE_FEASIBILITY",[25],"NA",{"count":27,"type":28},20,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","Pelvic Floor Muscle Therapy Website","8-week video-based, self-directed PFMT course",[35],"Video-based pelvic floor muscle therapy (PFMT)",[37,41,44,48],{"measure":38,"description":39,"timeFrame":40},"System Usability Scale (SUS) Score","The SUS is a 10-question survey that measures how easy a product or system is to use. Total score range from 0-100 with higher scores indicating better usability.","8 weeks",{"measure":42,"description":43,"timeFrame":40},"Percentage of participants video completion","Percentage of participants that complete at least 80% of the videos",{"measure":45,"description":46,"timeFrame":47},"Change in graded evaluation of exercises by pelvic floor therapist","Participants will be assessed and graded and by the pelvic floor physical therapist as below: 1 - cannot perform exercise, 2 - can partially perform exercise (needs some cueing and assistance), 3 - can independently perform exercise","baseline and 8 weeks",{"measure":49,"description":50,"timeFrame":51},"Adverse Events","Number of participants that experience at least one adverse event.","up to 8 weeks",[53,57,60,63,66],{"measure":54,"description":55,"timeFrame":56},"Short Form-12 (SF-12)","The SF-12 is an abbreviated version of the SF-36. The SF-12 is a validated survey that assesses a patient's health related quality of life across eight domains. The total score range is 0-100 with a physical component summary and a mental component summary. A higher score indicates better health for each of those components.","baseline and week 9",{"measure":58,"description":59,"timeFrame":56},"Cleveland Clinic Incontinence Score (CCIS)","The CCIS is a health-related quality of life measure that assesses how often and to what degree incontinence affects a person's life. The total score ranges from 0 to 20, with higher scores indicating higher levels of incontinence.",{"measure":61,"description":62,"timeFrame":56},"Patient Assessment of Constipation Symptoms (PAC-SYM)","The PAC-SYM is a questionnaire used to assess the severity of constipation symptoms in adults. Total score range 0-4 with higher scores indicating more severe constipation.",{"measure":64,"description":65,"timeFrame":56},"International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)","The ICIQ-SF is a brief patient-completed questionnaire that measures the impact of urinary incontinence (UI) on quality of life (QoL). The ICIQ-UI SF is scored on a scale of 0-21. A score of zero means no urine leakage and no impact on QoL.",{"measure":67,"description":68,"timeFrame":56},"Pelvic Organ Prolapse Symptom Score (POP-SS)","The POP-SS is a questionnaire that measures the severity of pelvic organ prolapse symptoms. The total score ranges from 0-28, with higher scores indicating more severe symptoms.","FEMALE","18 Years",false,{"inclusion":73,"exclusion":76,"raw_text":79},[74,75],"Diagnosis of pelvic floor dysfunction with referral for PFR","English-speaking",[77,78],"Unable to access web-based videos","Unable to speak English","Inclusion Criteria:\n\n* Diagnosis of pelvic floor dysfunction with referral for PFR\n* English-speaking\n\nExclusion Criteria:\n\n* Unable to access web-based videos\n* Unable to speak English",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":85,"status":8,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"Yale New Haven Hospital","New Haven","Connecticut","06520","United States",{"lat":91,"lon":92},41.30815,-72.92816,[94,99],{"name":95,"role":96,"phone":97,"email":98},"Anne Mongiu, MD, PhD","CONTACT","203-785-2616","Anne.mongiu@yale.edu",{"name":100,"role":96,"phone":101,"email":102},"Samantha Linhares, MD","203-843-6140","Samantha.linhares@yale.edu",[],[],[],{"nct_id":4,"conditions":107,"biomarkers":111},[108,19,109,110],"Anorectal Dysfunction","Pelvic Organ Prolapse","Urinary Incontinence",[],{"nct_id":4,"found":113,"summary":114,"prompt_version":124},true,{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an interventional pilot study with 20 planned participants. It is testing a new remote, web-accessible PFMT curriculum.","completed","Video-Based Pelvic Floor Muscle Therapy for Pelvic Floor Disorders","This study is testing an 8-week video-based, self-directed Pelvic Floor Muscle Therapy (PFMT) Website to see if it's a practical and helpful way to treat pelvic floor disorders like pelvic organ prolapse, urinary incontinence, and anorectal dysfunction. You may be able to join if you are an English-speaking woman with a diagnosis of pelvic floor dysfunction who has been referred for PFMT, and can access web-based videos. The researchers will measure how easy the website is to use, how much of the video course participants complete, and how a pelvic floor therapist evaluates your exercises. The study is currently unclear on its recruitment status and plans to enroll 20 participants.","Your progress will be evaluated at 8 weeks after starting the video course.",110,"You will complete a 5-10 minute survey at the start, have one in-person session with a pelvic floor therapist, complete an 8-week video course, and then have a final in-person session and 10-15 minute survey.","Not stated in the trial record.",[],"v2"]