Clinical trial NCT05540353: Transvaginal Low-level Laser Therapy to Improve Pelvic Pain and Sexual Function in Patients with Endometriosis.
Official title: Transvaginal Photobiomodulation for the Treatment of Dyspareunia in Endometriosis Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Endometriosis
Dyspareunia
Pelvic Pain
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Patty Brisben Foundation For Women's Sexual Health
First posted: 2022-09-14
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean change in pelvic pain
timeFrame: Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment
Secondary outcomes:
measure: Change in Female Sexual Function Index (FSFI) scores
timeFrame: Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.
measure: Change in Short Form-McGill Pain Questionnaire (SF-MPQ)
timeFrame: Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.
measure: Change in number of Sexually Satisfying Experiences (SSE)
timeFrame: Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.
measure: Change in clinic pain scores
timeFrame: Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: MedStar Lafayette Center
state: District of Columbia
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Mitchellville
country: United States
facility: MedStar Mitchellville Clinic
state: Maryland
city: Rockville
country: United States
facility: MedStar Rockville Clinic
state: Maryland
city: McLean
country: United States
facility: MedStar McLean Clinic
state: Virginia
Study officials:
affiliation: Medstar Health Research Institute
name: James Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stratton P, Khachikyan I, Sinaii N, Ortiz R, Shah J. Association of chronic pelvic pain and endometriosis with signs of sensitization and myofascial pain. Obstet Gynecol. 2015 Mar;125(3):719-728. doi: 10.1097/AOG.0000000000000663.
citation: Howard FM. Endometriosis and mechanisms of pelvic pain. J Minim Invasive Gynecol. 2009 Sep-Oct;16(5):540-50. doi: 10.1016/j.jmig.2009.06.017.
citation: FitzGerald MP, Payne CK, Lukacz ES, Yang CC, Peters KM, Chai TC, Nickel JC, Hanno PM, Kreder KJ, Burks DA, Mayer R, Kotarinos R, Fortman C, Allen TM, Fraser L, Mason-Cover M, Furey C, Odabachian L, Sanfield A, Chu J, Huestis K, Tata GE, Dugan N, Sheth H, Bewyer K, Anaeme A, Newton K, Featherstone W, Halle-Podell R, Cen L, Landis JR, Propert KJ, Foster HE Jr, Kusek JW, Nyberg LM; Interstitial Cystitis Collaborative Research Network. Randomized multicenter clinical trial of myofascial physical therapy in women with interstitial cystitis/painful bladder syndrome and pelvic floor tenderness. J Urol. 2012 Jun;187(6):2113-8. doi: 10.1016/j.juro.2012.01.123. Epub 2012 Apr 12.
citation: Chung H, Dai T, Sharma SK, Huang YY, Carroll JD, Hamblin MR. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng. 2012 Feb;40(2):516-33. doi: 10.1007/s10439-011-0454-7. Epub 2011 Nov 2.
citation: Kohli N, Jarnagin B, Stoehr AR, Lamvu G. An observational cohort study of pelvic floor photobiomodulation for treatment of chronic pelvic pain. J Comp Eff Res. 2021 Dec;10(17):1291-1299. doi: 10.2217/cer-2021-0187. Epub 2021 Sep 7.
citation: Zipper R, Pryor B, Lamvu G. Transvaginal Photobiomodulation for the Treatment of Chronic Pelvic Pain: A Pilot Study. Womens Health Rep (New Rochelle). 2021 Nov 23;2(1):518-527. doi: 10.1089/whr.2021.0097. eCollection 2021.