Transvaginal Electrical Stimulation for Myofascial Pelvic Pain

NCT05354869 | Recruiting DMC FDA Device

• 1 other identifier: 22-000062
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Myofascial Pelvic Pain

Keywords

high frequency transvaginal electrical stimulation; pelvic floor; chronic pelvic pain; muscle fatigue

Outcome Measures

Primary Outcomes (4)

• Change of myofascial pelvic pain symptoms

  The primary outcome will measure a change in pain on the 11-point Numeric Pain Rating Scale, where the minimum value of 0 indicates no pain and the maximum value of 10 indicates worse possible pain. Higher scores are associated with a worse outcome. Positive outcomes would have a 2-point reduction in mean pain intensity from baseline to post-treatment.

  8 weeks of treatment

• Patient perception of treatment delivery by an LVN in comparison to specialist MD

  Patients will complete the Patient Global Impression of Improvement (PGI-I) questionnaire, where the minimum value of 1 indicates a "very much better" change in pain and the maximum value of 7 indicates a "very much worse" change in pain. Responses will be compared between the two provider groups.

  8 weeks of treatment

• Patient satisfaction with treatment delivery by an LVN in comparison to specialist MD

  The investigators will use a Likert scale that measures satisfaction with treatment, where 0 = not satisfied and 10 = completely satisfied. Scores between the LVN and MD group will be compared.

  8 weeks of treatment

• Benefit of therapy

  Patients will answer a binary assessment of benefit from therapy with Yes or No response options. Yes responses will indicate patients found therapy beneficial whereas No responses will indicate therapy was not found beneficial. Responses will be compared between provider groups.

  8 weeks of treatment

Secondary Outcomes (6)

• Change in bothersome visceral bowel symptoms

  8 weeks

• Change in bothersome visceral bladder symptoms

  8 weeks

• Change in bothersome visceral sexual symptoms

  8 weeks

• Change in bothersome visceral genital symptoms

  8 weeks

• Change in pain severity

  8 weeks

Other Outcomes (1)

• Short-term durability of symptomatic improvements

  3 months

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Standard care

HF-TES by LVN

ACTIVE COMPARATOR

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.

Device: Urostym

HF-TES by Physician

ACTIVE COMPARATOR

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.

Device: Urostym

Interventions

Urostym DEVICE

electric pelvic floor muscle stimulator

Also known as: Hi frequency transvaginal electrical stimulation

HF-TES by LVN; HF-TES by Physician

Standard care BEHAVIORAL

patient education on home exercises and stretching

Also known as: usual care

Usual Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Only female participants are being studied.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Women's Pelvic Health

Los Angeles, California, 90095, United States

RECRUITING

Related Publications (6)

• Morris L, Newton RA. Use of high voltage pulsed galvanic stimulation for patients with levator ani syndrome. Phys Ther. 1987 Oct;67(10):1522-5. doi: 10.1093/ptj/67.10.1522.

  PMID: 3310051 BACKGROUND

• Nicosia JF, Abcarian H. Levator syndrome. A treatment that works. Dis Colon Rectum. 1985 Jun;28(6):406-8. doi: 10.1007/BF02560224.

  PMID: 3874049 BACKGROUND

• Sohn N, Weinstein MA, Robbins RD. The levator syndrome and its treatment with high-voltage electrogalvanic stimulation. Am J Surg. 1982 Nov;144(5):580-2. doi: 10.1016/0002-9610(82)90586-4.

  PMID: 6182809 BACKGROUND

• Billingham RP, Isler JT, Friend WG, Hostetler J. Treatment of levator syndrome using high-voltage electrogalvanic stimulation. Dis Colon Rectum. 1987 Aug;30(8):584-7. doi: 10.1007/BF02554802.

  PMID: 3497787 BACKGROUND

• Stewart F, Berghmans B, Bo K, Glazener CM. Electrical stimulation with non-implanted devices for stress urinary incontinence in women. Cochrane Database Syst Rev. 2017 Dec 22;12(12):CD012390. doi: 10.1002/14651858.CD012390.pub2.

  PMID: 29271482 BACKGROUND

• Bernier F, Davila GW. The treatment of nonobstructive urinary retention with high-frequency transvaginal electrical stimulation. Urol Nurs. 2000 Aug;20(4):261-4.

  PMID: 11998089 BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• A. Lenore Ackerman, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

A. Lenore Ackerman, MD, PhD

CONTACT

833-825-2974; aackerman@mednet.ucla.edu

Katie Levitt

CONTACT

3107946786; klevitt@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology and Director of Research

Model Details: Participants will be randomized to receive usual care or usual care and hi frequency transvaginal electrical stimulation administered by either a specialized urogynecology provider or licensed vocational nurse(LVN) using a secure online randomization system.

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: May 2, 2022
• Study Start: October 31, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)