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

Primary Purpose

Endometriosis, Dyspareunia, Pelvic Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transvaginal photobiomodulation
Sham therapy
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Arm Type

Active Comparator

Sham Comparator

Arm Label

Transvaginal photobiomodulation

Sham treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Female Sexual Function Index (FSFI) scores
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)
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)
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
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.

Full Information

First Posted
September 12, 2022
Last Updated
September 1, 2023
Sponsor
Medstar Health Research Institute
Collaborators
Patty Brisben Foundation For Women's Sexual Health
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1. Study Identification

Unique Protocol Identification Number
NCT05540353
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute
Collaborators
Patty Brisben Foundation For Women's Sexual Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Dyspareunia, Pelvic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transvaginal photobiomodulation
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Transvaginal photobiomodulation
Other Intervention Name(s)
SoLa Pelvic Therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change in pelvic pain
Description
Defined by mean change in 10-point Numerical pain rating scale (NPRS) from baseline scores, compared between treatment and sham control arms
Time Frame
Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment
Secondary Outcome Measure Information:
Title
Change in Female Sexual Function Index (FSFI) scores
Description
FSFI is a self-report questionnaire addressing six categories that contribute to female sexual satisfaction: desire, arousal, lubrication, orgasm, satisfaction, and pain.
Time Frame
Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.
Title
Change in Short Form-McGill Pain Questionnaire (SF-MPQ)
Description
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.
Time Frame
Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.
Title
Change in number of Sexually Satisfying Experiences (SSE)
Description
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.
Time Frame
Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.
Title
Change in clinic pain scores
Description
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.
Time Frame
Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa K Gonzales
Phone
2028776502
Email
Melissa.K.Gonzales@medstar.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Robinson, MD
Organizational Affiliation
Medstar Washington Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Thompson, MD
Email
rebecca.e.thompson@medstar.net
Facility Name
MedStar Lafayette Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Thompson, MD
Email
rebecca.e.thompson@medstar.net
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Thompson, MD
Email
rebecca.e.thompson@medstar.net
Facility Name
MedStar Mitchellville Clinic
City
Mitchellville
State/Province
Maryland
ZIP/Postal Code
20721
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Thompson, MD
Email
rebecca.e.thompson@medstar.net
Facility Name
MedStar Rockville Clinic
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Thompson, MD
Email
rebecca.e.thompson@medstar.net
Facility Name
MedStar McLean Clinic
City
McLean
State/Province
Virginia
ZIP/Postal Code
22101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Thompson, MD
Email
rebecca.e.thompson@medstar.net

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25730237
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.
Results Reference
background
PubMed Identifier
19835795
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.
Results Reference
background
PubMed Identifier
22503015
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.
Results Reference
background
PubMed Identifier
22045511
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.
Results Reference
background
PubMed Identifier
34490787
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.
Results Reference
background
PubMed Identifier
34841398
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.
Results Reference
background

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

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