Menu
Recruiting NCT06689891

Video-Based Pelvic Floor Muscle Therapy

No phase Interventional Pelvic Floor Disorder Pelvic Floor Muscle Exercise

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pelvic Floor Muscle Therapy Website.
Who it may be relevant to
Registry conditions: Pelvic Floor Disorder, Pelvic Floor Muscle Exercise. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Device Pelvic Floor Muscle Therapy Website
    8-week video-based, self-directed PFMT course

Primary outcome measures

  • System Usability Scale (SUS) Score [Time frame: 8 weeks]
  • Percentage of participants video completion [Time frame: 8 weeks]
  • Change in graded evaluation of exercises by pelvic floor therapist [Time frame: baseline and 8 weeks]
  • Adverse Events [Time frame: up to 8 weeks]
Secondary outcome measures (5)
  • Short Form-12 (SF-12) [Time frame: baseline and week 9]
  • Cleveland Clinic Incontinence Score (CCIS) [Time frame: baseline and week 9]
  • Patient Assessment of Constipation Symptoms (PAC-SYM) [Time frame: baseline and week 9]
  • International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) [Time frame: baseline and week 9]
  • Pelvic Organ Prolapse Symptom Score (POP-SS) [Time frame: baseline and week 9]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • Yale New Haven Hospital — New Haven

Identifiers

NCT: NCT06689891 · 2000037163

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗