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NCT Number: NCT06689891

Video-Based Pelvic Floor Muscle Therapy

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.

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Key information

Conditions

Pelvic Floor Disorder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pelvic Floor Disorders Pelvic Floor Muscle Exercise Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic Floor Muscle Therapy Website

Device

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

Primary outcomes

  1. 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.

  2. Percentage of participants video completion

    Time frame: 8 weeks

    Percentage of participants that complete at least 80% of the videos

  3. 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

  4. Adverse Events

    Time frame: up to 8 weeks

    Number of participants that experience at least one adverse event.

Secondary outcomes

  1. Short Form-12 (SF-12)

    Time frame: 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.

  2. Cleveland Clinic Incontinence Score (CCIS)

    Time frame: 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.

  3. Patient Assessment of Constipation Symptoms (PAC-SYM)

    Time frame: 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.

  4. International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)

    Time frame: 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.

  5. Pelvic Organ Prolapse Symptom Score (POP-SS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Mongiu, MD, PhD

CONTACT

[email protected]

203-785-2616

Samantha Linhares, MD

CONTACT

[email protected]

203-843-6140

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 15, 2024
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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