Transvaginal Low-level Laser Therapy to Improve Pelvic Pain and Sexual Function in Patients With Endometriosis.
Endometriosis, Dyspareunia, Pelvic Pain
About this trial
This is an interventional treatment trial for Endometriosis
Eligibility Criteria
Inclusion Criteria:
- Proficient English-speaking females
- Pathology proven endometriosis, >6 weeks from prior pelvic surgery
- Current dyspareunia
Exclusion Criteria:
- Unable to comply with study protocol
- Pregnant or attempting to become pregnant
- History of or active treatment for pelvic malignancy
- Currently taking light-sensitizing drugs
Sites / Locations
- MedStar Washington Hospital CenterRecruiting
- MedStar Lafayette CenterRecruiting
- MedStar Georgetown University HospitalRecruiting
- MedStar Mitchellville ClinicRecruiting
- MedStar Rockville ClinicRecruiting
- MedStar McLean ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Transvaginal photobiomodulation
Sham treatment
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
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