Usual Care for Pelvic Pain
Phase-Based Progress Estimates
Effectiveness
Safety
UCLA Center for Women's Pelvic Health, Los Angeles, CA
Pelvic Pain+1 More
Standard care - BehavioralEligibility
18+
Female
What conditions do you have?
Select
Eligibility
18+
Female
What conditions do you have?
Select
Study 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.
Eligible Conditions
- Pelvic Pain
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 6 Secondary · Reporting Duration: 3 months
3 months
Short-term durability of symptomatic improvements
8 weeks
Change in bothersome visceral bladder symptoms
Change in bothersome visceral bowel symptoms
Change in bothersome visceral genital symptoms
Change in bothersome visceral sexual symptoms
Change in pain features
Change in pain severity
8 weeks of treatment
Benefit of therapy
Change of myofascial pelvic pain symptoms
Patient perception of treatment delivery by an LVN in comparison to specialist MD
Patient satisfaction with treatment delivery by an LVN in comparison to specialist MD
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Usual Care
1 of 3
HF-TES by LVN
1 of 3
HF-TES by Physician
1 of 3
Active Control
60 Total Participants · 3 Treatment Groups
Primary Treatment: Usual Care · No Placebo Group · N/A
Usual Care
Behavioral
ActiveComparator Group · 1 Intervention: Standard care · Intervention Types: BehavioralHF-TES by LVN
Device
ActiveComparator Group · 1 Intervention: Urostym · Intervention Types: DeviceHF-TES by Physician
Device
ActiveComparator Group · 1 Intervention: Urostym · Intervention Types: DeviceTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months
Closest Location: UCLA Center for Women's Pelvic Health · Los Angeles, CA
N/AFirst Recorded Clinical Trial
1 TrialsResearching Pelvic Pain
0 CompletedClinical Trials
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,381 Previous Clinical Trials
6,521,087 Total Patients Enrolled
2 Trials studying Pelvic Pain
241 Patients Enrolled for Pelvic Pain
A. Lenore Ackerman, MD, PhDPrincipal InvestigatorUniversity of California, Los Angeles
Eligibility Criteria
Age 18+ · Female Participants · 5 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are between the ages of 18 and 65 years.
You have palpated trigger points in internal pelvic floor muscles on standardized myofascial pelvic floor exam.
You are willing to refrain from new clinical treatments that may affect pain during the study period.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Morris, Lydia, and Roberta A. Newton. 1987. “Use of High Voltage Pulsed Galvanic Stimulation for Patients with Levator Ani Syndrome”. Physical Therapy. Oxford University Press (OUP). doi:10.1093/ptj/67.10.1522.
- Nicosia, Jon F., and Herand Abcarian. 1985. “Levator Syndrome”. Diseases of the Colon & Rectum. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/bf02560224.
- Sohn, Norman, Michael A. Weinstein, and Richard D. Robbins. 1982. “The Levator Syndrome and Its Treatment with High-voltage Electrogalvanic Stimulation”. The American Journal of Surgery. Elsevier BV. doi:10.1016/0002-9610(82)90586-4.
- Stewart F, Berghmans B, Bø K, Glazener CM. Electrical stimulation with non-implanted devices for stress urinary incontinence in women. Cochrane Database Syst Rev. 2017 Dec 22;12:CD012390. doi: 10.1002/14651858.CD012390.pub2. Review.
- Billingham, Richard P., John T. Isler, William G. Friend, and Janice Hostetler. 1987. “Treatment of Levator Syndrome Using High-voltage Electrogalvanic Stimulation”. Diseases of the Colon & Rectum. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/bf02554802.
- SHAKER, HASSAN S., and MAGDY HASSOUNA. 1998. “Sacral Root Neuromodulation in Idiopathic Nonobstructive Chronic Urinary Retention”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00005392-199805000-00017.
- Anne Lenore Ackerman 2022. "Transvaginal Electrical Stimulation for Myofascial Pelvic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05354869.
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