Video-Based Pelvic Floor Muscle Therapy

NCT06689891 | Recruiting FDA Device

• 1 other identifier: 2000037163
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Muscle Exercise; Pelvic Floor Disorder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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

Study Arms (1)

Video-based pelvic floor muscle therapy (PFMT)

EXPERIMENTAL

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

Interventions

Pelvic Floor Muscle Therapy Website DEVICE

8-week video-based, self-directed PFMT course

Video-based pelvic floor muscle therapy (PFMT)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of pelvic floor dysfunction with referral for PFR
• English-speaking

You may not qualify if:

• Unable to access web-based videos
• Unable to speak English

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Central Study Contacts

Anne Mongiu, MD, PhD

CONTACT

203-785-2616; Anne.mongiu@yale.edu

Samantha Linhares, MD

CONTACT

203-843-6140; Samantha.linhares@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study population will include patients who have an indication for referral for pelvic floor rehabilitation (PFR).

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: June 9, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)