EndometriosisNCT05540353
Transvaginal Low-level Laser Therapy to Improve Pelvic Pain and Sexual Function in Patients with Endometriosis.
A study testing Transvaginal photobiomodulation in people with Endometriosis and Dyspareunia, run by Medstar Health Research Institute at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Dyspareunia, Pelvic Pain
- What is being tested?
- Transvaginal photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 6 sitesUnited States
- Study dates
- 2 May 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Proficient English-speaking females
- Pathology proven endometriosis, >6 weeks from prior pelvic surgery
- Current dyspareunia
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
MedStar McLean Clinic
McLean, Virginia, 22101
MedStar Mitchellville Clinic
Mitchellville, Maryland, 20721
MedStar Rockville Clinic
Rockville, Maryland, 20852
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
MedStar Lafayette Center
Washington D.C., District of Columbia, 20036
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20057
About this study
Official title: Transvaginal Photobiomodulation for the Treatment of Dyspareunia in Endometriosis Patients: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Endometriosis, Dyspareunia, Pelvic Pain
- Being tested
- Transvaginal photobiomodulation, Sham therapy
- Medical subject headings
- Endometriosis, Dyspareunia, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal photobiomodulationDevice
Also called SoLa Pelvic Therapy
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.
Sham therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Sham therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
FSFI is a self-report questionnaire addressing six categories that contribute to female sexual satisfaction: desire, arousal, lubrication, orgasm, satisfaction, and pain.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start2 May 2023
- Primary completion30 Jun 2024
- Study completion1 Jul 2024
Why it stopped: Study unable to be conducted with resources at site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Patty Brisben Foundation For Women's Sexual Health
- Responsible party
- Sponsor
- Investigators
- James Robinson, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540353
- Sponsor's protocol ID
- STUDY00005330
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2022
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25730237Howard 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.
PubMed 19835795FitzGerald 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.
PubMed 22503015Chung 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.
PubMed 22045511Kohli 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.
PubMed 34490787Zipper 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.
PubMed 34841398
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Photobiomodulation for the Treatment of Dyspareunia in Endometriosis Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05540353
- Acronym / sponsor ID
- STUDY00005330
- Conditions
- Endometriosis, Dyspareunia, Pelvic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study unable to be conducted with resources at site.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Patty Brisben Foundation For Women's Sexual Health
- Study start
- 2 May 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvaginal photobiomodulation | Active comparator | Device: Transvaginal photobiomodulationParticipants 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 |
| Sham treatment | Sham comparator | Device: Sham therapyParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Proficient English-speaking females
- Pathology proven endometriosis, >6 weeks from prior pelvic surgery
- Current dyspareunia
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvaginal photobiomodulationAlso: SoLa Pelvic TherapyLow 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. | Device | Transvaginal photobiomodulation |
| Sham therapyUse 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. | Device | Sham treatment |
Primary outcome
Mean change in pelvic pain
Time frame: 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
4 secondary outcomes
Change in Female Sexual Function Index (FSFI) scores
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.
Results and safety
The study was stopped early (reason given: Study unable to be conducted with resources at site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Background: PubMed 25730237Stratton 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.
- Background: PubMed 19835795Howard 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.
- Background: PubMed 22503015FitzGerald 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.
- Background: PubMed 22045511Chung 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.
- Background: PubMed 34490787Kohli 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.
- Background: PubMed 34841398Zipper 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.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Robinson, MD principal investigator
Medstar Health Research Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal photobiomodulation in people with Endometriosis and Dyspareunia, run by Medstar Health Research Institute at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study unable to be conducted with resources at site.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in pelvic pain (time frame: Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05540353, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.