Transvaginal electrical stimulation for pelvic pain relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of high-frequency transvaginal electrical stimulation (HF-TES) in treating myofascial pelvic pain (MPP) in women. It is a randomized trial involving 60 participants who will be assigned to receive either HF-TES or standard care, which includes education and low-impact exercise. The study aims to assess pain reduction, improved circulation, and tissue healing through this innovative treatment approach. Participants will undergo thorough assessments to ensure eligibility and monitor their progress throughout the trial.

Why it matters

Who can join: the full rules

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

Where it's running

• UCLA Center for Women's Pelvic Health
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: A. Lenore Ackerman, MD, PhD — University of California, Los Angeles
• Study coordinator: A. Lenore Ackerman, MD, PhD
• Email: aackerman@mednet.ucla.edu
• Phone: 833-825-2974

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.