VOICE
Vaginal Photobiomodulation for Chronic Pelvic Pain
A Randomized Clinical Trial
VOICE: Vaginal Photobiomodulation for Chronic Pelvic Pain.
A Randomized Clinical Trial.
VOICE is designed to be a high-quality clinical trial that evaluates the efficacy of photobiomodulation compared to sham for the treatment of chronic pelvic pain. The objective of this research is to determine if photobiomodulation, using the SoLá Pelvic Therapy® device can improve pelvic pain and quality of life. Researchers also want to know if the treatment protocol is feasible and if participants are satisfied with the therapy.
What is being done in the VOICE clinical trial?
Study participants will receive treatments with SoLá Pelvic Therapy® device or sham, an identical device that doesn't deliver energy. These treatments are not painful. All participants will be evaluated and screened by study pelvic pain specialists. In this study, 128 participants will be randomly assigned to one of the two study groups. Both groups will receive 8 pelvic treatments; each treatment lasts less than 6 minutes and treatments will be administered twice a week over a period of 4 weeks. Before each session, you will fill out short questionnaires, and two final questionnaires one week and three months after your last treatment. These questionnaires will help researchers track pain levels, quality of life, and satisfaction with treatment.
Study eligibility
To participate in the VOICE trial you must be a woman who:
-
is 18 years old or older
-
suffers with moderate-severe pelvic pain
-
has had pelvic pain for 3 months or longer
-
is NOT pregnant and is willing to not get pregnant during the trial
-
is willing to participate in a clinical trial, undergo treatments, and complete questionnaires
-
has a computer, smartphone, or tablet
-
is able to travel to a participating healthcare facility
Study site locations
Nurture Women's Health, Frisco, TX
The Orady Women's Clinic, San Francisco, CA
Boston Urogyn, Wellesley Hills, MA
Obgyn South, Birmingham, AL
Horizon's Health and Wellness, Bridgewater, MA
Minnesota Women's Care: OBGYN and Urogynecology, Maplewood, MN
The Clark Center for Urogynecology, Northport Beach, CA
Kansas City Urogynecology, Kansas City, KS (site closed, physician retired)
​
​
Additional study information
-
Participants will be paid for participation and reimbursed for parking and driving expenses.
-
All participants will be evaluated by a gynecology pelvic pain specialist.
-
Participants will be asked to use a method of birth control while enrolled in the study.
-
Benefits include possible pain relief and evaluation by a gynecologist who specializes in pelvic pain.
-
Risks include temporary increase or no change in pain, temporary vaginal or bladder infection, discomfort during treatment or pelvic examination.
