Video-Based Pelvic Floor Muscle Therapy

NCT ID: NCT06689891

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-09

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Pelvic Floor Disorder Pelvic Floor Muscle Exercise

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Study population will include patients who have an indication for referral for pelvic floor rehabilitation (PFR).
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pelvic Floor Muscle Therapy Website

Intervention Type DEVICE

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

Interventions

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Pelvic Floor Muscle Therapy Website

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anne Mongiu, MD, PhD

Role: CONTACT

203-785-2616

Samantha Linhares, MD

Role: CONTACT

203-843-6140

Other Identifiers

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2000037163

Identifier Type: -

Identifier Source: org_study_id

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