Usual Care for Pelvic Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UCLA Center for Women's Pelvic Health, Los Angeles, CA
Pelvic Pain+1 More
Standard care - Behavioral
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

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

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: Behavioral
HF-TES by LVN
Device
ActiveComparator Group · 1 Intervention: Urostym · Intervention Types: Device
HF-TES by Physician
Device
ActiveComparator Group · 1 Intervention: Urostym · Intervention Types: Device

Trial 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
Photo of Los Angeles 1Photo of Los Angeles 2Photo of Los Angeles 3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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