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. Patients 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. The primary objective is to the determine the feasibility and accessibility of using a video-based PFMT for patients with pelvic floor dysfunction. The secondary objective is to determine whether video-based PFMT can improve symptomatology and quality of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
20
8-week video-based, self-directed PFMT course
Yale New Haven Hospital
New Haven, Connecticut, United States
RECRUITINGSystem 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 weeks
Percentage of participants video completion
Percentage of participants that complete at least 80% of the videos
Time frame: 8 weeks
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 weeks
Adverse Events
Number of participants that experience at least one adverse event.
Time frame: up to 8 weeks
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 9
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 9
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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 9
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 9
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.
Time frame: baseline and week 9