NCT06673108 · SoLa Pelvic Therapy
Vaginal Photobiomodulation for Chronic Pelvic Pain
(VOICE)
What this study 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.
View original scientific description
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.
Interventions
DEVICE
SoLa Pelvic Therapy
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.
Primary outcome measures
Overall pelvic pain
Time frame: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
Overall pelvic pain level as measured on a 0-10 numeric rating pain scale (NRPS). On this scale, 0 represents no pain and 10 represents wors pain possible. Pain will be analyzed as median pain levels and % of participants achieving a minimal clinically important difference (MCID) defined as reduction in pain level of 2 or more NRPS points.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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 pl
Where
- Birmingham, Alabama
- San Francisco, California
- Overland Park, Kansas
- Boston, Massachusetts
- Frisco, Texas
Collaborators
Uroshape LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 4, 2024 · Source of record for eligibility and locations