Utilizing Remote, Video-Based Pelvic Floor Muscle Therapy: A Feasibility Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Yale University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- System Usability Scale (SUS) Score
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of pelvic floor dysfunction with referral for PFR
- •English-speaking
Exclusion Criteria
- •Unable to access web-based videos
- •Unable to speak English
Arms & Interventions
Video-based pelvic floor muscle therapy (PFMT)
Patients will complete a series of surveys before and after the intervention. They will complete 8 weeks of video-based PFMT with an initial and final in-person session with a pelvic floor therapist.
Intervention: Pelvic Floor Muscle Therapy Website (Device)
Outcomes
Primary Outcomes
System Usability Scale (SUS) Score
Time Frame: 8 weeks
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.
Percentage of participants video completion
Time Frame: 8 weeks
Percentage of participants that complete at least 80% of the videos
Change in graded evaluation of exercises by pelvic floor therapist
Time Frame: baseline and 8 weeks
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
Adverse Events
Time Frame: up to 8 weeks
Number of participants that experience at least one adverse event.
Secondary Outcomes
- Short Form-12 (SF-12)(baseline and week 9)
- Cleveland Clinic Incontinence Score (CCIS)(baseline and week 9)
- Patient Assessment of Constipation Symptoms (PAC-SYM)(baseline and week 9)
- International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)(baseline and week 9)
- Pelvic Organ Prolapse Symptom Score (POP-SS)(baseline and week 9)