Transvaginal photobiomodulation for Dyspareunia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
MedStar Lafayette Center, Washington, United States
Dyspareunia+2 More
Transvaginal photobiomodulation - Device
Eligibility
18+
Female
What conditions do you have?
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Study 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.

Eligible Conditions

  • Dyspareunia
  • Endometrioma
  • Pelvic Pain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.

Week 6
Mean change in pelvic pain
Week 6
Change in Female Sexual Function Index (FSFI) scores
Change in Short Form-McGill Pain Questionnaire (SF-MPQ)
Change in clinic pain scores
Change in number of Sexually Satisfying Experiences (SSE)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Transvaginal photobiomodulation
1 of 2
Sham treatment
1 of 2
Active Control
Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Transvaginal photobiomodulation · Has Placebo Group · N/A

Transvaginal photobiomodulation
Device
ActiveComparator Group · 1 Intervention: Transvaginal photobiomodulation · Intervention Types: Device
Sham treatment
Device
ShamComparator Group · 1 Intervention: Sham therapy · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measured at baseline, after 4th treatment, 1-2 weeks after completion of treatment, and 6 weeks after completion of treatment.

Trial Background

Rebecca E Thompson, Fellow of Minimally Invasive Gynecologic Surgery at MedStar Washington Hospital Center/Georgetown University
Principal Investigator
Medstar Health Research Institute
Closest Location: MedStar Lafayette Center · Washington, United States
Photo of washington  1Photo of washington  2Photo of washington  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Dyspareunia
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Female Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have endometriosis, >6 weeks from prior pelvic surgery.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References