Transvaginal Low-level Laser Therapy to Improve Pelvic Pain and Sexual Function in Patients with Endometriosis.
- Conditions
- Pelvic PainEndometriosisDyspareunia
- Interventions
- Device: Sham therapyDevice: Transvaginal photobiomodulation
- Registration Number
- NCT05540353
- Lead Sponsor
- Medstar Health Research Institute
- Brief Summary
Dyspareunia is defined as pain with penetrative sexual intercourse. Women with endometriosis have a nine-fold increased risk of dyspareunia, when compared to the general female population.
A prospective single-blinded randomized controlled trial will be performed evaluating the change in pelvic pain and sexual satisfaction scores from baseline to 6 weeks after treatment with transvaginal photobiomodulation therapy or sham therapy. Treatment will involve 9 planned treatment sessions over 3-4 weeks. 40 women will be included in the study.
- Detailed Description
Active intervention: Transvaginal photobiomodulation (TV-PBM) Control intervention: Sham transvaginal probe
All subjects will complete 9 treatments over 3-4 weeks and all treatments will be performed with a sheet over the patient's pelvic area to prevent the subject from seeing the probe light, as well as a screen blocking the patient's view of the machine. Subjects randomized to active therapy will undergo TV-PBM treatment during each session per standard TV-PBM treatment protocol. Subjects randomized to sham will undergo blinded sham therapy using an identical probe but without photobiomodulation. Sham therapy will involve the same regimen as the active arm but with the machine turned off. Instead, there will be a recording of the usual noise of the machine to mimic the activation that occurs when stepping on the pedal with the machine on for TV-PBM treatment.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 6
- Proficient English-speaking females
- Pathology proven endometriosis, >6 weeks from prior pelvic surgery
- Current dyspareunia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham treatment Sham 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 Transvaginal photobiomodulation Transvaginal photobiomodulation 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
- Primary Outcome Measures
Name Time Method Mean change in pelvic pain Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment Defined by mean change in 10-point Numerical pain rating scale (NPRS) from baseline scores, compared between treatment and sham control arms
- Secondary Outcome Measures
Name Time Method Change in Female Sexual Function Index (FSFI) scores Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment. FSFI is a self-report questionnaire addressing six categories that contribute to female sexual satisfaction: desire, arousal, lubrication, orgasm, satisfaction, and pain.
Change in Short Form-McGill Pain Questionnaire (SF-MPQ) Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment. SF-MPQ is a self-reported questionnaire to help describe pain character and intensity. It consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.
Change in number of Sexually Satisfying Experiences (SSE) Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment. A 2 question form asking number of SSEs in the past 7 days and the past 1 month. An SSE is defined as: a sexual experience in which you are satisfied with those factors that are most important to you. The experience can be with a partner or alone.
Change in clinic pain scores Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment. A standardized pelvic exam to evaluate each muscle group in abdomen and pelvis with a patient assigned pain score (0-10) to each area palpated.
Trial Locations
- Locations (6)
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
MedStar Lafayette Center
🇺🇸Washington, District of Columbia, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
MedStar Mitchellville Clinic
🇺🇸Mitchellville, Maryland, United States
MedStar Rockville Clinic
🇺🇸Rockville, Maryland, United States
MedStar McLean Clinic
🇺🇸McLean, Virginia, United States