Vaginal Photobiomodulation for Chronic Pelvic Pain
Vaginal Photobiomodulation for Chronic Pelvic Pain: a Randomized Controlled Trial
SoLa Pelvic Therapy
126 participants
Oct 17, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Age 18 years or older;
- CPP for 3 months or longer;
- Overall pelvic pain severity ≥4 in the last 7 days;
- Pelvic muscle tenderness pain level ≥4.
Exclusion Criteria15
- Previous vaginal or vulvar laser therapy;
- Receiving concurrent pelvic physical therapy;
- Unable to tolerate vaginal/pelvic examination
- Taking drugs that have heat- or light- sensitive contraindications;
- Subjectively reports abnormal or decreased sensation in the vagina or rectum;
- History of cancer of the cervix, vagina, uterus, bladder, or vulva or suspected of having neoplasia or pre-cancerous lesions;
- History of autoimmune inflammatory conditions such as vulvar lichen sclerosis or other types of dermatoses;
- History of vaginal trauma, ulcerations, erosions, or other evidence of vaginal and vulvar skin breakdown;
- Less than 6 months post-partum;
- Actively trying to get pregnant or not willing to use contraception during the trial;
- Positive pregnancy test or planning to get pregnant during the study;
- Vaginal discharge or bleeding concerning for neoplasia, infectious, or autoimmune condition; *
- Pelvic pain has not been fully evaluated or pain is not confirmed as chronic pelvic pain;
- Does not speak, read, or writes English and thus cannot complete surveys;
- Does not have access to smart digital devices or computer, or cannot receive emails.
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Interventions
SoLa Pelvic Therapy laser emits near-infrared (810-980 nm wavelength) energy to the vaginal tissues. The device treats at 5-8 W for 3-6 minutes and delivers a fluence of 3,000 and 5,000 J/cm2 through a sterile vaginal probe. Specific treatment time is calculated based on vaginal length. Based on a code input, the device can cycle between emitting laser energy or sham which is visible light without focused laser energy.
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06673108