Clinical trial NCT06673108: Vaginal Photobiomodulation for Chronic Pelvic Pain
Official title: Vaginal Photobiomodulation for Chronic Pelvic Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome (CPPS)
Lead sponsor: SoLa Pelvic Therapy
Sponsor class: INDUSTRY
Collaborators: name: Uroshape LLC
First posted: 2024-11-04
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This clinical trial will be a multi-center, triple-masked randomized study comparing vaginal photobiomodulation to sham, for the treatment of chronic pelvic pain in women. The study will include 126 participants, 63 randomized to vaginal photobiomodulation and 63 randomized to vaginal sham treatment. Potential participants will be recruited in communities and clinics where gynecologists are routinely evaluating patients for chronic pelvic pain.

Women who fulfill inclusion criteria will undergo, screening gynecologic evaluation to ensure they can participate. Informed and written consent will be obtained from all study participants prior to enrollment.

After consent, participants will be randomized to 8 treatments with active photobiomodulation or sham administered twice a week. Study subjects will be randomized using blocked 1:1 randomization with random permuted blocks of 4. Participants, study investigators, staff, and statisticians will remain masked throughout the study and unaware of whether sham or active laser is being administered to each participant.

Treatments will be administered using the SoLá Pelvic Therapy laser, which has been modified to emit sham or active photobiomodulation through the vagina using a thin laser wand protected by a sterile plastic covering. Treatments will be administered by a gynecology providers who specialize in evaluation and management of chronic pelvic pain. The SoLá Pelvic Therapy device auto-calculates power and duration of treatment based on vaginal length. The procedure typically lasts 3-6 minutes depending on the vaginal length and the pre-determined dosing selected by the device.

Patient reported pain levels will be assessed prior to each treatment and again at 1-week and 3-months after treatment. Pain levels will be obtained from both groups at baseline and after each treatment, while demographics, pain intensity, pain impact, pain behavior, and quality of life measures (QoL) will be collected at baseline and after treatment. Need for additional therapies, global impression of change, adherence and satisfaction will be assessed after 8 treatments. To assess effect duration, both groups will be followed for an additional 3 months, after which pain levels, QoL, use of additional treatments, global health, global impression of change, and satisfaction with the procedure will be assessed. After the 3-month follow-up, participation will come to an end.

The primary outcome will be to determine the percentage of participants who achieve a minimal clinically important difference (MCID) in overall pelvic pain, defined as a post-treatment decrease of ≥2 points on a 0-10 pain NRS (Numeric Rating Scale) at 3 months compared to baseline. Secondary outcomes include changes from baseline in:

* mean NRS pain levels of overall pelvic pain and symptom specific pelvic pain (pain with exercise, sitting, standing, bowel movements, urination, and intercourse);
* percentage of patients achieving MICD for symptom specific pelvic pain
* quality of life measured by decrease in pain intensity, impact, and interference, reduced need for additional treatments;
* improvement in global health;
* global impression of change,
* adherence and satisfaction with treatment. The intervention will be considered superior if 30% or higher percentage of participants achieve MCID compared to placebo (e.g., 30% in sham group vs 60%), or the intervention results in ≥1.1 NRS points reduction in mean pain levels compared to sham (e.g., intervention reduces mean pain levels by 2.4 points while sham reduces mean pain levels by 1.2 NRS points).

All patient reported outcomes (PROs) will be recorded using electronic surveys; many are specifically validated to measure pelvic pain, pelvic function, and quality of life.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older;
2. CPP for 3 months or longer;
3. Overall pelvic pain severity ≥4 in the last 7 days;
4. Pelvic muscle tenderness pain level ≥4.

Exclusion Criteria:

1. Previous vaginal or vulvar laser therapy;
2. Receiving concurrent pelvic physical therapy;
3. Unable to tolerate vaginal/pelvic examination
4. Taking drugs that have heat- or light- sensitive contraindications;
5. Subjectively reports abnormal or decreased sensation in the vagina or rectum;
6. History of cancer of the cervix, vagina, uterus, bladder, or vulva or suspected of having neoplasia or pre-cancerous lesions;
7. History of autoimmune inflammatory conditions such as vulvar lichen sclerosis or other types of dermatoses;
8. History of vaginal trauma, ulcerations, erosions, or other evidence of vaginal and vulvar skin breakdown;
9. Less than 6 months post-partum;
10. Actively trying to get pregnant or not willing to use contraception during the trial;
11. Positive pregnancy test or planning to get pregnant during the study;
12. Vaginal discharge or bleeding concerning for neoplasia, infectious, or autoimmune condition; \*
13. Pelvic pain has not been fully evaluated or pain is not confirmed as chronic pelvic pain;
14. Does not speak, read, or writes English and thus cannot complete surveys;
15. Does not have access to smart digital devices or computer, or cannot receive emails.

Primary outcomes:
measure: Overall pelvic pain
timeFrame: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
Secondary outcomes:
measure: Symptom specific pelvic pain
timeFrame: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
measure: Pain impact
timeFrame: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
measure: Quality of life
timeFrame: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
measure: Global physical and mental health
timeFrame: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
measure: Satisfaction with treatment.
timeFrame: At 1-week after completing treatment.
measure: Adherence with treatment.
timeFrame: After 5 treatments are completed.
measure: Need for additional treatment
timeFrame: This questionnaire is completed once a week, prior to each treatment through administration of all 8 treatments (which are administered twice a week), and again at 3 months after completing the last treatment.
measure: Global impression of change
timeFrame: At 1-week after completing treatment, and at 3 months after completing treatment.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Obgyn South
state: Alabama
city: San Francisco
country: United States
facility: The Orady Womens Clinic
state: California
city: Overland Park
country: United States
facility: Urogynecology of Kansas City
state: Kansas
city: Boston
country: United States
facility: Boston Urogyn
state: Massachusetts
city: Frisco
country: United States
facility: Nurture Women's Health
state: Texas
Study officials:
affiliation: SoLá Pelvic Therapy
name: Georgine Lamvu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Zipper R, Pryor B. Evaluation of a novel deep tissue transvaginal near-infrared laser and applicator in an ovine model. Lasers Med Sci. 2022 Feb;37(1):639-643. doi: 10.1007/s10103-021-03315-z. Epub 2021 Apr 14.