No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
126 (estimated)
Sponsor
SoLa Pelvic Therapy · Industry
Who this trial is looking for
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The goal of this clinical study is to determine if 8 treatments with photobiomodulation using near-infrared laser energy can help reduce chronic pelvic pain in women. Additionally, researchers want to determine if treatment with this type of energy can also alleviate pain with activities such as standing, sitting, urinating, having bowel movements and intercourse.
Trial Locations
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Eligibility Criteria
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. Unabl…
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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