Status:
RECRUITING
Transvaginal Electrical Stimulation for Myofascial Pelvic Pain
Lead Sponsor:
University of California, Los Angeles
Conditions:
Myofascial Pelvic Pain
Eligibility:
FEMALE
18-65 years
Phase:
NA
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 trea...
Detailed Description
This will be a prospective randomized trial. Sixty subjects with suspected myofascial pelvic pain will be recruited from the University of California, Los Angeles (UCLA) Center for Women's Pelvic Heal...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05354869
Start Date
October 31 2022
End Date
December 1 2026
Last Update
January 9 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLA Center for Women's Pelvic Health
Los Angeles, California, United States, 90095