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Transvaginal Electrical Stimulation for Myofascial Pelvic Pain

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
Female
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
65 Years

Inclusion Criteria:

  • Women between 18 and 65 years of age
  • Pelvic pain for more than 6 months duration
  • Report an average daily pain intensity score of at least 4 (on a 0 to 10 scale)
  • Palpable trigger points in internal pelvic floor muscles on standardized myofascial pelvic floor exam
  • Willing to refrain from new clinical treatments that may affect pain during the study period

Exclusion Criteria:

  • Inability to participate in weekly clinic visits
  • Prior invasive pelvic procedures for pain (e.g., prior pelvic surgery, sacroiliac joint injections, ganglion impar block, bladder instillations, sacral neuromodulation, intradetrusor or intramuscular Botox®)
  • Active urinary tract infection (UTI) or vaginal infection
  • Pregnancy, childbirth during the previous12 months, currently planning pregnancy
  • Drug addiction
  • Prior pelvic floor physical therapy
  • Malignancy or other serious medical condition (e.g., poorly controlled diabetes [Glycated hemoglobin (HgA1c) > 8], neurologic or rheumatic disease)
  • Diagnosed with an alternate cause of pelvic pain (e.g., interstitial cystitis, dysmenorrhea/menorrhalgia, vestibulodynia, vulvar dermatoses)
  • Urinary retention
  • Greater than stage 3 pelvic organ prolapse
  • Indwelling vaginal devices (e.g., vaginal pessary, contraceptive ring)
  • Inability to sign an informed consent, fill out questionnaires, or complete study interviews

Join this Trial

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Study Stats
Protocol No.
22-000062
Category
Urology
Contact
Crystal Cisneros
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05354869
For detailed technical eligibility, visit ClinicalTrials.gov.