Transvaginal Low-level Laser Therapy to Improve Pelvic Pain and Sexual Function in Patients with Endometriosis.

NCT05540353 | Terminated FDA Device

• 1 other identifier: STUDY00005330
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 6

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.

Conditions

Endometriosis; Dyspareunia; Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• Mean change in pelvic pain

  Defined by mean change in 10-point Numerical pain rating scale (NPRS) from baseline scores, compared between treatment and sham control arms

  Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment

Secondary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Transvaginal photobiomodulation

ACTIVE COMPARATOR

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

Device: Transvaginal photobiomodulation

Sham treatment

SHAM COMPARATOR

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

Device: Sham therapy

Interventions

Transvaginal photobiomodulation DEVICE

Low light laser therapy applied transvaginally using a small vaginal wand with sterile disposable wand covers. The intervention last 3-5 minutes based on a surface area calculation performed at the beginning of the intervention, and involves a gentle in and out motion of the wand to deliver light energy to the muscles of the pelvic floor.

Also known as: SoLa Pelvic Therapy

Transvaginal photobiomodulation

Sham therapy DEVICE

Use of the same vaginal wand as active arm, but without activation of the machine. The intervention last 3-5 minutes, and involves a gentle in and out motion of the wand to massage the muscles of the pelvic floor, without delivery of light therapy.

Sham treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Proficient English-speaking females
• Pathology proven endometriosis, \>6 weeks from prior pelvic surgery
• Current dyspareunia

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Patty Brisben Foundation For Women's Sexual Health: collaborator

Study Sites (6)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MedStar Lafayette Center

Washington D.C., District of Columbia, 20036, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20057, United States

Location

MedStar Mitchellville Clinic

Mitchellville, Maryland, 20721, United States

Location

MedStar Rockville Clinic

Rockville, Maryland, 20852, United States

Location

MedStar McLean Clinic

McLean, Virginia, 22101, United States

Location

Related Publications (6)

• 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.

  PMID: 25730237 BACKGROUND

• 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.

  PMID: 19835795 BACKGROUND

• 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.

  PMID: 22503015 BACKGROUND

• 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.

  PMID: 22045511 BACKGROUND

• 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.

  PMID: 34490787 BACKGROUND

• 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.

  PMID: 34841398 BACKGROUND

MeSH Terms

Conditions

Endometriosis; Dyspareunia; Pelvic Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James Robinson, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 14, 2022
• Study Start: May 2, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 1, 2024
• Last Updated: February 19, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)