Recruiting

Transvaginal Electrical Stimulation

Sponsor:

UCLA

Code:

NCT05354869

Conditions

Myofascial Pelvic Pain

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Urostym

Standard care

Study Details

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

Study ID

NCT05354869

Start date

Oct 31, 2022

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Usual Care

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.

active comparator: HF-TES by LVN

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.

active comparator: HF-TES by Physician

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.

Interventions

Urostym

electric pelvic floor muscle stimulator

Standard care

patient education on home exercises and stretching

Primary outcome measure

  • Change of myofascial pelvic pain symptoms [ Time Frame: 8 weeks of treatment ]
  • Patient perception of treatment delivery by an LVN in comparison to specialist MD [ Time Frame: 8 weeks of treatment ]
  • Patient satisfaction with treatment delivery by an LVN in comparison to specialist MD [ Time Frame: 8 weeks of treatment ]
  • Benefit of therapy [ Time Frame: 8 weeks of treatment ]

Central Contacts and Locations

Central contacts

A. Lenore Ackerman, MD, PhD

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

Katie Levitt

3107946786klevitt@mednet.ucla.edu

Locations

UCLA Center for Women's Pelvic Health

Recruiting

Los Angeles, California, United States, 90095

Contacts

A. Lenore Ackerman, MD, PhD

8338252974aackerman@mednet.ucla.edu

Katie Levitt

310-794-6786klevitt@mednet.ucla.edu

Principal Investigator:

A. Lenore Ackerman, MD, PhD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-04-13.