Vaginal Photobiomodulation for Chronic Pelvic Pain

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSoLa Pelvic Therapy

About this trial

The goal of this clinical study is to determine if 8 treatments with photobiomodulation using near-infrared laser energy can help reduce chronic pelvic pain in women. Additionally, researchers want to determine if treatment with this type of energy can also alleviate pain with activities such as standing, sitting, urinating, having bowel movements and intercourse.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older;

CPP for 3 months or longer;

Overall pelvic pain severity ≥4 in the last 7 days;

Pelvic muscle tenderness pain level ≥4.

Disqualifiers

Previous vaginal or vulvar laser therapy;

Receiving concurrent pelvic physical therapy;

Unable to tolerate vaginal/pelvic examination

Taking drugs that have heat- or light- sensitive contraindications;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SoLa Pelvic Therapy

    Device

    SoLa Pelvic Therapy laser emits near-infrared (810-980 nm wavelength) energy to the vaginal tissues. The device treats at 5-8 W for 3-6 minutes and delivers a fluence of 3,000 and 5,000 J/cm2 through a sterile vaginal probe. Specific treatment time is calculated based on vaginal length. Based on a code input, the device can cycle between emitting laser energy or sham which is visible light without focused laser energy.

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Vaginal photobiomodulationActive comparator 1 intervention
Group B: Sham-Light without laser energy.Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall pelvic pain

Overall pelvic pain level as measured on a 0-10 numeric rating pain scale (NRPS). On this scale, 0 represents no pain and 10 represents wors pain possible. Pain will be analyzed as median pain levels and % of participants achieving a minimal clinically important difference (MCID) defined as reduction in pain level of 2 or more NRPS points.

Time frame
At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.

Secondary outcomes

1

Symptom specific pelvic pain

Pain with exercise, sitting, standing, bowel movements, urination, and intercourse as measured on a 0-10 numeric rating pain scale and analyzed in the same manner as the primary outcome 'overall pelvic pain'.

Time frame
At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
2

Pain impact

Pain intensity as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale and Pain Interference Scale. The scales assess the impact of pain on activity, mood, relationships, sleep, and general enjoyment of life. The PROMIS Pain Intensity Scale asks participants to categorize pain intensity in the last 7 days, as an ordinal categorical scale using words like 'had no pain', 'mild', 'moderate', 'severe', and 'very severe', and the PROMIS Pain Interference Scale asks participants about the degree that pain interferes with activity, work around the home, participation in social activities, things usually done for fun, enjoyment of life, family life. Participants can rank their answers as an ordinal scale using words like 'not at all', 'a little bit', 'somewhat', 'quite a bit', and 'very much'.

Time frame
At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
3

Quality of life

As measured by the Short Form-12 Health Survey (SF-12), a self-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 assess general health and well-being \[or health-related quality of life (HRQOL)\], including the impact of any and all illnesses on a broad range of functional domains. The SF-12 has two components scored on a range of 0-100: a physical component score (PCS) and a mental component score (MCS). A score of 50 or less on the PCS-12 indicates poor physical functioning or a physical condition, because scores above 50 indicate better than average health related quality of life, while a score below 50 suggests below average health. A score of 42 or less on the MCS-12 may indicate clinical depression. Therefore, SF-12 scores above 50 indicate better health and scores below 50 indicate worse than average health.

Time frame
At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
4

Global physical and mental health

Global physical and mental health as measured by the PROMIS Global Health questionnaire. It contains questions that allows participants to rank their general physical health, ability to carry out every day physical activities such as walking, climbing stairs, carry groceries, or moving a chair, using an ordinal scale ranking 'excellent', 'very good', 'good', 'fair', and 'poor'. This questionnaire also contains questions that allows participants to rate their mental health including ability to think, and satisfaction with social activities and relationships on an ordinal scale ranking 'excellent', 'very good', 'good', 'fair', and 'poor'.

Time frame
At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SoLa Pelvic Therapy

Lead sponsor

Uroshape LLC

Collaborator