Transvaginal Photobiomodulation for the Treatment of Chronic Pelvic Pain: A Pilot Study.
Ralph Zipper, Brian Pryor, Georgine Lamvu
https://pubmed.ncbi.nlm.nih.gov/34841398Actively Recruiting
Phase 2
Age: 18Years +
FEMALE
ID06673108
Vaginal Photobiomodulation for Chronic Pelvic Pain: a Randomized Controlled Trial
Led by SoLa Pelvic Therapy · Updated on 2024-11-04
126
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
SoLa Pelvic Therapy
Lead Sponsor
U
Uroshape LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of vaginal photobiomodulation with near-infrared laser energy to help reduce chronic pelvic pain in women. This Phase 2, multi-center, triple-masked randomized trial compares active laser treatment to a sham (inactive) light therapy. The goal is to see if this treatment can also relieve pain during activities like standing, sitting, urinating, bowel movements, and intercourse. The study includes 126 women with chronic pelvic pain lasting at least 3 months. Participants will be randomly assigned to receive eight treatments of either active vaginal photobiomodulation or sham light therapy, twice a week. Treatments use the SoLá Pelvic Therapy laser device, which adjusts power and duration based on vaginal length. Each session lasts 3 to 6 minutes and is performed by gynecology providers specializing in pelvic pain. The study phases include screening, treatment, and follow-up periods, with participants masked to their treatment group. During the study, pain levels and quality of life will be assessed at baseline, before each treatment, one week after completing the treatments, and three months later. Other measures include pain intensity, impact, behavior, global health, satisfaction, and need for additional therapies. All patient-reported outcomes will be collected using electronic surveys. The main outcome is the percentage of women who experience a clinically meaningful reduction in overall pelvic pain at three months after treatment compared to baseline.
CONDITIONS
Brief Title
Vaginal Photobiomodulation for Chronic Pelvic Pain
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Chronic pelvic pain lasting 3 months or more
- Overall pelvic pain severity of 4 or higher in the last 7 days
- Pelvic muscle tenderness pain level of 4 or higher
You will not qualify if you...
- Previous vaginal or vulvar laser therapy
- Receiving concurrent pelvic physical therapy
- Unable to tolerate vaginal or pelvic examination
- Taking drugs with heat- or light-sensitive contraindications
- Abnormal or decreased sensation in the vagina or rectum
- History of cancer in cervix, vagina, uterus, bladder, or vulva or suspected precancerous lesions
- Autoimmune inflammatory conditions like vulvar lichen sclerosis or other dermatoses
- Vaginal trauma, ulcerations, erosions, or skin breakdown in vaginal or vulvar area
- Less than 6 months postpartum
- Actively trying to get pregnant or unwilling to use contraception during the trial
- Positive pregnancy test or planning pregnancy during the study
- Vaginal discharge or bleeding concerning for neoplasia, infection, or autoimmune condition
- Pelvic pain not fully evaluated or not confirmed as chronic pelvic pain
- Does not speak, read, or write English sufficiently to complete surveys
- No access to smart digital devices or computer or unable to receive emails
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for gynecologic evaluation and consent
Treatment
Duration - 4 weeks
Participants receive 8 treatments of vaginal photobiomodulation or sham light therapy administered twice a week by gynecology providers specialized in chronic pelvic pain management. Each treatment lasts 3-6 minutes depending on vaginal length.
Twice weekly visits for 8 treatments
Follow-up
Duration - 3 months
Participants are followed for 3 months after completing treatment to assess pain levels, quality of life, need for additional treatments, global health, and satisfaction with the procedure.
1 visit at 1 week and 1 visit at 3 months after treatment completion
Trial Site Locations
Total: 5 locations
1
Obgyn South
Birmingham, Alabama, United States, 35209
Actively Recruiting
2
The Orady Womens Clinic
San Francisco, California, United States, 94109
Not Yet Recruiting
3
Urogynecology of Kansas City
Overland Park, Kansas, United States, 66214
Actively Recruiting
4
Boston Urogyn
Boston, Massachusetts, United States, 02481
Not Yet Recruiting
5
Nurture Women's Health
Frisco, Texas, United States, 75035
Actively Recruiting
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Research Team
G
Georgine Lamvu, MD, MPH
P
Pilar Garcia, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Evaluation of a novel deep tissue transvaginal near-infrared laser and applicator in an ovine model.
Ralph Zipper, Brian Pryor
https://pubmed.ncbi.nlm.nih.gov/33855615