RecruitingNot ApplicableNCT05354869

Transvaginal Electrical Stimulation for Myofascial Pelvic Pain

Repurposing Pelvic Floor Electrical Stimulation for the Treatment of Chronic Pelvic Pain

Sponsor

University of California, Los Angeles

Enrollment

60 participants

Start Date

Oct 31, 2022

Study Type

INTERVENTIONAL

Conditions

Myofascial Pelvic Pain

Summary

Myofascial Pelvic Pain (MPP) is a frequently overlooked musculoskeletal cause of chronic pelvic pain affecting 10-20% of all adult women. Despite high prevalence and societal costs, few effective treatments exist and are difficult to access due to shortages of skilled personnel. Treatments for MPP using electrical stimulation to induce muscle fatigue have proven efficacy at reducing pain, improving circulation, and promoting tissue healing, but have proven difficult to implement in gynecologic practice. The aim of this three-arm randomized study is to evaluate the utility of transvaginal electrical stimulation at a fixed frequency of 200 Hz in women with symptomatic MPP in comparison to the standard, first-line treatment with education, stretching, and low-impact exercise. Nursing staff without prior training will be taught to deliver this high-frequency transvaginal electrical stimulation (HF-TES) treatment using the device. Responses to treatment provided by a specialist physician and licensed vocational nurse will be compared. Patients with \>50% pain improvement will determine the effectiveness of HF-TES. Responses to treatment provided by a specialist physician and licensed vocational nurse will also be compared. Participants will be followed for 3 months following treatment completion.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing transvaginal electrical stimulation as a treatment for myofascial pelvic pain — a type of chronic pelvic pain caused by painful trigger points (tight, tender spots) in the pelvic floor muscles. The goal is to see whether this targeted therapy can reduce pain levels. You may be eligible if... - You are a woman between 18 and 65 years old - You have had pelvic pain for more than 6 months - Your average daily pain score is at least 4 out of 10 - You have confirmed pelvic floor trigger points on examination - You are willing to avoid new pain treatments during the study You may NOT be eligible if... - You cannot attend weekly clinic visits - You have had prior invasive pelvic procedures such as surgery, nerve blocks, bladder treatments, or Botox injections for pain - You have an active urinary tract or vaginal infection - You are pregnant, gave birth in the past 12 months, or are planning pregnancy - You have had prior pelvic floor physical therapy - You have been diagnosed with interstitial cystitis, vestibulodynia, or another identified cause of pelvic pain - You have stage 3+ pelvic organ prolapse or a urinary retention issue - You have an indwelling vaginal device (e.g., pessary, contraceptive ring) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEUrostym

electric pelvic floor muscle stimulator

BEHAVIORALStandard care

patient education on home exercises and stretching

Locations(1)

UCLA Center for Women's Pelvic Health

Los Angeles, California, United States

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NCT05354869

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