Video-Based Pelvic Floor Muscle Therapy

Utilizing Remote, Video-Based Pelvic Floor Muscle Therapy: A Feasibility 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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Floor Muscle Exercise; Pelvic Floor Disorder
• Intervention / Treatment: Device: Pelvic Floor Muscle Therapy Website

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Mongiu, MD, PhD; Phone Number: 203-785-2616; Email: Anne.mongiu@yale.edu
• Study Contact Backup: Name: Samantha Linhares, MD; Phone Number: 203-843-6140; Email: Samantha.linhares@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Pelvic Floor Muscle Therapy Website; 8-week video-based, self-directed PFMT course

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Percentage of participants video completion	Percentage of participants that complete at least 80% of the videos	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	baseline and 8 weeks
Adverse Events	Number of participants that experience at least one adverse event.	up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	baseline and week 9
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.	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.	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.	baseline and week 9

Collaborators and Investigators

• Sponsor: Yale University

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Pelvic Floor Disorders
• Other Study ID Numbers: 2000037163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No