Could a simple electrical device ease chronic pelvic pain?
NCT ID NCT05354869
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a device that delivers gentle electrical stimulation to the pelvic floor can reduce chronic pelvic pain in women. Sixty women with myofascial pelvic pain will either receive the device treatment or standard care (education and exercises). The goal is to see if the device provides better pain relief and can be delivered by nurses without special training.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Urostym device (high-frequency transvaginal electrical stimulation)
- What this could lead to
- If successful, this could offer a new, easy-to-access treatment option for women with chronic pelvic pain that doesn't require a specialist.
- What could go wrong
- This is a small, early-stage study with only 60 participants, so results may not apply to everyone. The device may not work better than standard care, and there is a risk of discomfort or no improvement.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UCLA Center for Women's Pelvic Health
RECRUITINGLos Angeles, California, 90095, United States
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