Video-Based Pelvic Floor Muscle Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of pelvic floor dysfunction with referral for PFR
English-speaking
Disqualifiers
Unable to access web-based videos
Unable to speak English
Trial design
Design model
Single group
Treatments tested in this trial
Pelvic Floor Muscle Therapy Website
Device8-week video-based, self-directed PFMT course
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Video-based pelvic floor muscle therapy (PFMT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
8 weeks2
Percentage of participants video completion
Percentage of participants that complete at least 80% of the videos
Time frame
8 weeks3
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
Time frame
baseline and 8 weeks4
Adverse Events
Number of participants that experience at least one adverse event.
Time frame
up to 8 weeksSecondary outcomes
1
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.
Time frame
baseline and week 92
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.
Time frame
baseline and week 93
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.
Time frame
baseline and week 94
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.
Time frame
baseline and week 9Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov