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New treatment option for Chronic Pelvic Pain
Official title Vaginal Photobiomodulation for Chronic Pelvic Pain
ClinicalTrials.gov ID: NCT06673108
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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.
You likely can't join if
- 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;
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- San Francisco, California, United States
- Overland Park, Kansas, United States
- Boston, Massachusetts, United States
- Frisco, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; San Francisco, California, United States; Overland Park, Kansas, United States; Boston, Massachusetts, United States; Frisco, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.