Pelvic Floor Exercises for Pelvic Floor Disorders

Overseen By Anne Mongiu, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Web access, Non-English speaking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

20 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Video-Based Pelvic Floor Muscle Therapy for Pelvic Floor Disorders?

Research shows that pelvic floor muscle training (PFMT) is effective for improving urinary symptoms and pelvic organ prolapse in women, and similar exercises have been beneficial for men after prostate surgery. These findings suggest that video-based pelvic floor exercises could also be effective for pelvic floor disorders. ^{1 2 3 4 5}

Is pelvic floor muscle training safe for humans?

Pelvic floor muscle training is generally considered safe for humans, as it is recommended by health guidelines for conditions like urinary incontinence and pelvic organ prolapse. There is no specific safety data mentioned in the research articles, but the widespread recommendation suggests it is safe. ^{2 6 7 8 9}

How is Video-Based Pelvic Floor Muscle Therapy different from other treatments for pelvic floor disorders?

Video-Based Pelvic Floor Muscle Therapy is unique because it uses video guidance to help patients perform pelvic floor exercises correctly, which can enhance learning and adherence compared to traditional methods that may not provide visual feedback. ^{3 10 11 12 13}

What is the purpose of this 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.

Eligibility Criteria

This trial is for individuals with pelvic floor disorders such as organ prolapse, urinary incontinence, and anorectal dysfunction. Participants should be comfortable using a website for video-based therapy sessions.

Inclusion Criteria

I have been diagnosed with pelvic floor dysfunction and referred for pelvic floor rehabilitation.

English-speaking

Exclusion Criteria

Unable to access web-based videos

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Initial Assessment

Participants complete a 5-10-minute survey and have an in-person session with a pelvic floor therapist

1 week

1 visit (in-person)

Treatment

Participants undergo 8 weeks of video-based pelvic floor muscle therapy with an initial and final in-person session

8 weeks

2 visits (in-person)

Follow-up

Participants complete a final set of surveys and are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• Video-Based Pelvic Floor Muscle Therapy

Trial Overview The study tests the effectiveness of a remote, video-based pelvic floor muscle therapy (PFMT) program to improve symptoms related to various pelvic floor disorders.

Participant Groups

Group I: Video-based pelvic floor muscle therapy (PFMT) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Findings from Research

Pelvic floor muscle training (PFMT) is an effective first-line treatment for urinary incontinence and pelvic organ prolapse, yet awareness among healthcare professionals is limited, as shown in a study of 44 staff members.

Only 53% of healthcare professionals felt confident in performing pelvic-floor assessments, and many were unaware of standardized assessment methods, indicating a need for improved education and resources to better support patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staff awareness of pelvic floor muscle training (PFMT) in tertiary care - a qualitative cross-sectional study. Soundararajan, K., Dilruksha Chandrasiri, M., Balchandra, P.[2022]

Pelvic muscle exercises have been used for 50 years to manage pelvic floor dysfunction, particularly after childbirth, and their applications have expanded over time.

The article reviews various techniques for these exercises, including biofeedback and electrical stimulation, and highlights their effectiveness in treating stress and urge urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonsurgical management of pelvic floor dysfunction. Visco, AG., Figuers, C.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of In-person FPMRS-directed Pelvic Floor Therapy Program Versus Unsupervised Pelvic Floor Exercises Following Prostatectomy. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Real-World Effectiveness of Pelvic Floor Muscle Training for Women With Urinary Tract Symptoms and/or Prolapse. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effect of postpartum pelvic floor muscle training on vaginal symptoms and sexual dysfunction-secondary analysis of a randomised trial. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Bladder-neck effective, integrative pelvic floor rehabilitation program: follow-up investigation. [2015]

5. Brazil pubmed.ncbi.nlm.nih.gov

Pelvic floor exercises with biofeedback for stress urinary incontinence. [2019]

6. China pubmed.ncbi.nlm.nih.gov

[Pelvic floor muscle strength screening and analysis of its related factors among migrant women in the Pearl River Delta]. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Staff awareness of pelvic floor muscle training (PFMT) in tertiary care - a qualitative cross-sectional study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training: Novel versus traditional remote rehabilitation methods. A systematic review and meta-analysis on their effectiveness for women with urinary incontinence. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Commercially Available Home Pelvic Training Devices for the Treatment of Pelvic Floor Disorders: A Systematic Review and Meta-analysis. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Nonsurgical management of pelvic floor dysfunction. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle rehabilitation using biofeedback. [2022]

12. Korea (South) pubmed.ncbi.nlm.nih.gov

Pelvic Floor Muscle Exercise Education and Factors Associated with Implementation among Antenatal Women in Hospital Universiti Sains Malaysia. [2020]

13. England pubmed.ncbi.nlm.nih.gov

Vibrating vaginal balls to improve pelvic floor muscle performance in women after childbirth: a protocol for a randomised controlled feasibility trial. [2016]