Pelvic Floor Disorder, Pelvic Floor Muscle Exercise
Conditions
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.
Interventions
DEVICEPelvic Floor Muscle Therapy Website
8-week video-based, self-directed PFMT course
Sponsors
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Study population will include patients who have an indication for referral for pelvic floor rehabilitation (PFR).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (SUS) Score | 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 | 8 weeks | Percentage of participants that complete at least 80% of the videos |
| Change in graded evaluation of exercises by pelvic floor therapist | 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 | up to 8 weeks | Number of participants that experience at least one adverse event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Form-12 (SF-12) | baseline and week 9 | 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. |
| Cleveland Clinic Incontinence Score (CCIS) | baseline and week 9 | 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. |
| Patient Assessment of Constipation Symptoms (PAC-SYM) | baseline and week 9 | 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. |
| International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) | baseline and week 9 | 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. |
| Pelvic Organ Prolapse Symptom Score (POP-SS) | baseline and week 9 | 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. |
Countries
United States
Contacts
CONTACTAnne Mongiu, MD, PhD
CONTACTSamantha Linhares, MD
Outcome results
None listed