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Light therapy inside the body: a new hope for chronic pelvic pain?

NCT ID NCT06673108

Symptom relief Sponsor: SoLa Pelvic Therapy Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial tests whether eight sessions of vaginal photobiomodulation—using near-infrared laser energy—can reduce chronic pelvic pain in women. Participants must have had pelvic pain for at least three months and report moderate to severe pain. The study compares the laser treatment to a sham (visible light without laser energy) to see if the real treatment eases pain during daily activities like sitting, standing, and intercourse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vaginal photobiomodulation using near-infrared laser energy delivered via a sterile probe
What this could lead to
If effective, this could offer a non-drug, non-surgical option for women with chronic pelvic pain, potentially easing pain during daily activities and intercourse.
What could go wrong
This is a phase 2 trial, so results are preliminary. The sham control uses visible light, which may not fully blind participants, and the treatment requires multiple sessions, which may not suit everyone.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

128 people

The number who actually took part.

Started

Oct 2024

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18 years or older; 2. CPP for 3 months or longer; 3. Overall pelvic pain severity ≥4 in the last 7 days; 4. Pelvic muscle tenderness pain level ≥4. Exclusion Criteria: 1. Previous vaginal or vulvar laser therapy; 2. Receiving concurrent pelvic physical therapy; 3. Unable to tolerate vaginal/pelvic examination 4. Taking drugs that have heat- or light- sensitive contraindications; 5. Subjectively reports abnormal or decreased sensation in the vagina or rectum; 6. History of cancer of the cervix, vagina, uterus, bladder, or vulva or suspected of having neoplasia or pre-cancerous lesions; 7. History of autoimmune inflammatory conditions such as vulvar lichen sclerosis or other types of dermatoses; 8. History of vaginal trauma, ulcerations, erosions, or other evidence of vaginal and vulvar skin breakdown; 9. Less than 6 months post-partum; 10. Actively trying to get pregnant or not willing to use contraception during the trial; 11. Positive pregnancy test or planning to get pregnant during the study; 12. Vaginal discharge or bleeding concerning for neoplasia, infectious, or autoimmune condition; \* 13. Pelvic pain has not been fully evaluated or pain is not confirmed as chronic pelvic pain; 14. Does not speak, read, or writes English and thus cannot complete surveys; 15. Does not have access to smart digital devices or computer, or cannot receive emails.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic pelvic pain Chronic pelvic pain syndrome (CPPS)

Contacts and locations

Locations

  • Boston Urogyn

    Boston, Massachusetts, 02481, United States

  • Horizons Health and Wellness

    Bridgewater, Massachusetts, 02324, United States

  • IntimMedicine Specialists

    Washington D.C., District of Columbia, 20036, United States

  • Minnesota Women's Care: OBGYN and Urogynecology

    Maplewood, Minnesota, 55109, United States

  • Nurture Women's Health

    Frisco, Texas, 75035, United States

  • Obgyn South

    Birmingham, Alabama, 35209, United States

  • The Clark Center for Urogynecology

    Newport Beach, California, 92663, United States

  • The Continence Program-Southeast Urogyn

    Flowood, Mississippi, 39232, United States

  • The Orady Womens Clinic

    San Francisco, California, 94109, United States

  • The Thompkins Center

    Brentwood, Tennessee, 37027, United States

  • Urogynecology of Kansas City

    Overland Park, Kansas, 66214, United States

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