Transvaginal electrical stimulation for pelvic pain relief
Repurposing Pelvic Floor Electrical Stimulation for the Treatment of Chronic Pelvic Pain
This study is testing whether high-frequency electrical stimulation can help women with pelvic pain feel better compared to standard care like education and exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05354869 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 65 with chronic pelvic pain lasting more than six months and a daily pain intensity score of at least 4.
Not a fit: Patients with prior invasive pelvic procedures for pain or those with active infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improved quality of life for women suffering from myofascial pelvic pain.
How similar studies have performed: While the use of electrical stimulation for pelvic pain has shown promise, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.