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Photobiomodulation
Low-Level Laser Therapy for Endometriosis
N/A
Recruiting
Led By James Robinson, MD
Research Sponsored by Medstar Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Proficient English-speaking females
Current dyspareunia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment
Awards & highlights
Study Summary
This trial will compare the effects of transvaginal photobiomodulation therapy to sham therapy in women with endometriosis-related dyspareunia.
Who is the study for?
This trial is for English-speaking women with confirmed endometriosis experiencing pain during intercourse, who are more than 6 weeks post any pelvic surgery. It's not suitable for those pregnant or trying to conceive, with a history of pelvic cancer, under treatment for such cancers, or taking drugs that increase light sensitivity.Check my eligibility
What is being tested?
The study tests transvaginal photobiomodulation therapy—a type of low-level laser treatment—against sham (placebo) therapy to see if it reduces pelvic pain and improves sexual satisfaction in endometriosis patients. Participants will undergo 9 sessions over 3-4 weeks.See study design
What are the potential side effects?
While the specific side effects are not detailed here, similar therapies may cause mild discomfort or irritation at the application site. Since this is a low-level laser therapy, risks tend to be lower compared to invasive procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman who speaks English fluently.
Select...
I experience pain during intercourse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change in pelvic pain
Secondary outcome measures
Change in Female Sexual Function Index (FSFI) scores
Change in Short Form-McGill Pain Questionnaire (SF-MPQ)
Change in clinic pain scores
+1 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Transvaginal photobiomodulationActive Control1 Intervention
Participants will undergo active transvaginal photobiomodulation therapy per clinic protocol, using the SoLa Pelvic Therapy system. This includes 9 treatments, each lasting about 3-5 minutes. A sterile narrow vaginal probe is inserted into the vagina, the low-level laser is activated, and the probe is slowly moved along the vaginal walls for the indicated period of time, via a surface area power calculation based on the measured vaginal length at the beginning of the procedure. The 9 treatments must be completed in 3-4 weeks.
Intervention: Active SoLa Low-level laser therapy
Group II: Sham treatmentPlacebo Group1 Intervention
Participants will undergo sham transvaginal photobiomodulation therapy, following the same protocol as the active arm, without activation of the machine. This includes 9 treatments, lasting 3-5 minutes each. A sterile narrow vaginal probe is inserted into the vagina, the machine is NOT activated, and the inactive probe is slowly moved along the vaginal walls for 3-5 minutes. The 9 treatments must be completed in 3-4 weeks.
Intervention: Mock treatment with inactivated probe
Find a Location
Who is running the clinical trial?
Medstar Health Research InstituteLead Sponsor
189 Previous Clinical Trials
115,533 Total Patients Enrolled
Patty Brisben Foundation For Women's Sexual HealthOTHER
6 Previous Clinical Trials
355 Total Patients Enrolled
James Robinson, MDPrincipal InvestigatorMedstar Washington Hospital Center
1 Previous Clinical Trials
300 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on medication that increases my sensitivity to light.I have had or am being treated for cancer in my pelvic area.I am a woman who speaks English fluently.I experience pain during intercourse.I have a confirmed diagnosis of endometriosis and it's been over 6 weeks since my last pelvic surgery.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Sham treatment
- Group 2: Transvaginal photobiomodulation
Awards:
This trial has 0 awards, including:Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research currently accept volunteers?
"Unfortunately, the study listed on clinicaltrials.gov is not accepting new participants at this time. The trial was initiated in January 1st 2023 and last updated November 21st 2022. However, there are 123 other trials actively enrolling patients currently."
Answered by AI
What is the geographic scope of this research trial?
"At this time, 6 different medical centres are recruiting trial participants. 3 of these locations can be found in Mitchellville, McLean and Rockville while the other 3 remain undisclosed. In order to reduce travel-related stressors associated with enrollment, it is advisable to seek out a location near you."
Answered by AI
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