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Electrical Stimulation

Usual Care for Myofascial Pelvic Pain

N/A
Recruiting
Led By A. Lenore Ackerman, MD, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will test the effectiveness of a new, high-frequency transvaginal electrical stimulation (HF-TES) treatment for myofascial pelvic pain (MPP) in comparison to the standard, first-line treatment of education, stretching, and low-impact exercise.

Who is the study for?
This trial is for women aged 18-65 with chronic pelvic pain lasting over 6 months and a daily pain score of at least 4. Participants should have palpable trigger points in their pelvic floor muscles but no other major health issues or causes for their pain, such as interstitial cystitis or recent surgeries. They must not be pregnant, planning pregnancy, or have had childbirth within the last year.Check my eligibility
What is being tested?
The study tests transvaginal electrical stimulation using a device called Urostym against standard care (education, stretching, low-impact exercise) to treat Myofascial Pelvic Pain. It's a three-arm randomized study where nursing staff will administer the treatment and compare it to specialist-provided care over a period of three months.See study design
What are the potential side effects?
While specific side effects are not listed here, transvaginal electrical stimulation may cause discomfort during application, potential muscle soreness afterwards similar to post-exercise feelings, and possible irritation at the site of use.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Benefit of therapy
Change of myofascial pelvic pain symptoms
Patient perception of treatment delivery by an LVN in comparison to specialist MD
+1 more
Secondary outcome measures
Change in bothersome visceral bladder symptoms
Change in bothersome visceral bowel symptoms
Change in bothersome visceral genital symptoms
+3 more
Other outcome measures
Short-term durability of symptomatic improvements

Trial Design

3Treatment groups
Active Control
Group I: Usual CareActive Control1 Intervention
The current standard, first line treatment for MPP is a program of education, home exercises, and stretching. At enrollment, subjects will be counseled about the origins of myofascial pain in a one-on-one setting with the aid of informational handouts. They will be counseled about specific practices, such as Kegel exercises, volitional holding of urine or stool, and intensive exercise, that aggravate pelvic floor hypertonicity. They will be counseled about appropriate hydration and maintaining an adequate bowel regimen to avoid constipation. A stretching regimen aimed at abdominal and pelvic muscle release with elements of self-massage should be performed three times daily. Lastly, subjects will be prescribed 20 minutes of walking daily. Subjects will be recommended to continue this long-term, self-care program indefinitely.
Group II: HF-TES by LVNActive Control1 Intervention
In-office pulsed HF-TES will be delivered by licensed vocational nurse using the Urostym® clinic-based Pelvic Floor Rehabilitation System. An LVN will undergo didactic and practical training, which will include a detailed orientation to the device. Sessions of electric muscle stimulation will be performed at a frequency of 200 Hz (to induce a passive pelvic floor muscle contraction) for 20 min weekly using a pulse duration of 1 ms of stimulation and an interpulse interval of 4.1 ms. Stimulation intensity (current) will be adjusted manually to palpable, but not painful, stimulation. Vaginal and surface abdominal electromyographic monitoring (EMG) will be conducted throughout the treatment session, recording the average pre- and post-treatment values for each session. In subjects whose pelvic floor EMG does not normalize to <4 millielectronvolts (mV) in a 20-minute session, the subsequent session will be increased to 30 minutes.
Group III: HF-TES by PhysicianActive Control1 Intervention
A urogynecologic specialist will deliver HF-TES in office using Urostym® pelvic floor rehabilitation system. A physician will undergo didactic and practical training, which will include a detailed orientation to the device. Sessions of electric muscle stimulation will be performed at a frequency of 200 Hz (to induce a passive pelvic floor muscle contraction) for 20 min weekly using a pulse duration of 1 ms of stimulation and an interpulse interval of 4.1 ms. Stimulation intensity (current) will be adjusted manually to palpable, but not painful, stimulation. Vaginal and surface abdominal electromyographic monitoring (EMG) will be conducted throughout the treatment session, recording the average pre- and post-treatment values for each session. In subjects whose pelvic floor EMG does not normalize to <4 millielectronvolts (mV) in a 20-minute session, the subsequent session will be increased to 30 minutes.

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Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,538 Previous Clinical Trials
10,266,971 Total Patients Enrolled
A. Lenore Ackerman, MD, PhDPrincipal InvestigatorUniversity of California, Los Angeles
~19 spots leftby Mar 2025
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