Actively Recruiting
Vaginal Photobiomodulation for Chronic Pelvic Pain
Led by SoLa Pelvic Therapy · Updated on 2024-11-04
126
Participants Needed
5
Research Sites
84 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
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.
CONDITIONS
Official Title
Vaginal Photobiomodulation for Chronic Pelvic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Chronic pelvic pain lasting 3 months or longer
- Overall pelvic pain severity of 4 or higher in the last 7 days
- Pelvic muscle tenderness with 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
- Reports abnormal or decreased sensation in vagina or rectum
- History of cancer or suspected neoplasia in cervix, vagina, uterus, bladder, or vulva
- History of autoimmune inflammatory conditions like vulvar lichen sclerosis or other dermatoses
- History of vaginal trauma, ulcers, erosions, or skin breakdown in vaginal or vulvar areas
- 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
- Does not have access to smart digital devices or computer or cannot receive emails
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
G
Georgine Lamvu, MD, MPH
CONTACT
P
Pilar Garcia, MD
CONTACT
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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