Recruiting

Pelvic Floor Therapy

Sponsor:

Yale University

Code:

NCT06689891

Conditions

Pelvic Floor Disorder

Pelvic Floor Muscle Exercise

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pelvic Floor Muscle Therapy Website

Study Details

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 Disorder

Pelvic Floor Muscle Exercise

Study ID

NCT06689891

Start date

Jun 9, 2025

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

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.

Interventions

Pelvic Floor Muscle Therapy Website

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Anne Mongiu, MD, PhD

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

Samantha Linhares, MD

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

Locations

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-01-16.