Pelvic Floor DisorderNCT06689891
Video-Based Pelvic Floor Muscle Therapy
A study testing Pelvic Floor Muscle Therapy Website in people with Pelvic Floor Disorder and Pelvic Floor Muscle Exercise, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Disorder, Pelvic Floor Muscle Exercise
- What is being tested?
- Pelvic Floor Muscle Therapy Website
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of pelvic floor dysfunction with referral for PFR
- English-speaking
Who cannot join
- Unable to access web-based videos
- Unable to speak English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
Official title: Utilizing Remote, Video-Based Pelvic Floor Muscle Therapy: A Feasibility Trial
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.
Read the 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.
- Being tested
- Pelvic Floor Muscle Therapy Website
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle Therapy WebsiteDevice
8-week video-based, self-directed PFMT course
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Pelvic Floor Muscle Therapy Website |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Percentage of participants video completion
Percentage of participants that complete at least 80% of the videos
Measured: 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
Measured: baseline and 8 weeks
Adverse Events
Number of participants that experience at least one adverse event.
Measured: up to 8 weeks
Secondary outcomes (5)
Short Form-12 (SF-12)
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.
Measured: baseline and week 9
Cleveland Clinic Incontinence Score (CCIS)
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.
Measured: baseline and week 9
Patient Assessment of Constipation Symptoms (PAC-SYM)
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.
Measured: baseline and week 9
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
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.
Measured: baseline and week 9
Pelvic Organ Prolapse Symptom Score (POP-SS)
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.
Measured: baseline and week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start9 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study population will include patients who have an indication for referral for pelvic floor rehabilitation (PFR).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689891
- Sponsor's protocol ID
- 2000037163
- Status last verified
- Jan 2026
- First submitted
- 13 Nov 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Remote, Video-Based Pelvic Floor Muscle Therapy: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT06689891
- Acronym / sponsor ID
- 2000037163
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study population will include patients who have an indication for referral for pelvic floor rehabilitation (PFR).
| Arm | Type | Receives |
|---|---|---|
| Video-based pelvic floor muscle therapy (PFMT) | Experimental | Device: Pelvic Floor Muscle Therapy WebsitePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of pelvic floor dysfunction with referral for PFR
- English-speaking
Key exclusion criteria (2 listed)
- Unable to access web-based videos
- Unable to speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Floor Muscle Therapy Website8-week video-based, self-directed PFMT course | Device | Video-based pelvic floor muscle therapy (PFMT) |
Primary outcome
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.
Percentage of participants video completion
Time frame: 8 weeks
Percentage of participants that complete at least 80% of the videos
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
Adverse Events
Time frame: up to 8 weeks
Number of participants that experience at least one adverse event.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Muscle Therapy Website in people with Pelvic Floor Disorder and Pelvic Floor Muscle Exercise, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Mongiu, MD, PhD (203-785-2616, Anne.mongiu@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (SUS) Score (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.