Chronic Pelvic PainPhase 2VOICENCT06673108
Vaginal Photobiomodulation for Chronic Pelvic Pain
A Phase 2 study testing SoLa Pelvic Therapy in people with Chronic Pelvic Pain and Chronic Pelvic Pain Syndrome (CPPS), run by SoLa Pelvic Therapy at 11 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Pelvic Pain, Chronic Pelvic Pain Syndrome (CPPS)
- What is being tested?
- SoLa Pelvic Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 11 sitesUnited States
- Study dates
- 17 Oct 2024to 17 Jun 2026
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- Subjectively reports abnormal or decreased sensation in the vagina or rectum;
- History of cancer of the cervix, vagina, uterus, bladder, or vulva or suspected of having neoplasia or pre-cancerous lesions;
Show all 15Show fewer
- History of autoimmune inflammatory conditions such as vulvar lichen sclerosis or other types of dermatoses;
- History of vaginal trauma, ulcerations, erosions, or other evidence of vaginal and vulvar skin breakdown;
- Less than 6 months post-partum;
- Actively trying to get pregnant or not willing to use contraception during the trial;
- Positive pregnancy test or planning to get pregnant during the study;
- Vaginal discharge or bleeding concerning for neoplasia, infectious, or autoimmune condition; *
- Pelvic pain has not been fully evaluated or pain is not confirmed as chronic pelvic pain;
- Does not speak, read, or writes English and thus cannot complete surveys;
- Does not have access to smart digital devices or computer, or cannot receive emails.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Obgyn South
Birmingham, Alabama, 35209
Boston Urogyn
Boston, Massachusetts, 02481
The Thompkins Center
Brentwood, Tennessee, 37027
Horizons Health and Wellness
Bridgewater, Massachusetts, 02324
The Continence Program-Southeast Urogyn
Flowood, Mississippi, 39232
Nurture Women's Health
Frisco, Texas, 75035
Minnesota Women's Care: OBGYN and Urogynecology
Maplewood, Minnesota, 55109
The Clark Center for Urogynecology
Newport Beach, California, 92663
Urogynecology of Kansas City
Overland Park, Kansas, 66214
The Orady Womens Clinic
San Francisco, California, 94109
IntimMedicine Specialists
Washington D.C., District of Columbia, 20036
About this study
Official title: Vaginal Photobiomodulation for Chronic Pelvic Pain: A Randomized Controlled 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.
Read the 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.
- Being tested
- SoLa Pelvic Therapy, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoLa Pelvic TherapyDevice
Also called Low level laser therapy
SoLá Pelvic Therapy laser emits near-infrared (810-980 nm wavelength) energy to the vaginal tissues. The device treats at 6 W for 3-6 minutes and delivers a fluence of 300-1,600 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.
ShamDevice
Sham red light WITHOUT focused laser energy.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal photobiomodulation | Active comparator | Vaginal photobiomodulation with near-infrared (810-980nm wavelength) energy. Receives: Device: SoLa Pelvic Therapy |
| Sham-Light without laser energy. | Sham comparator | Vaginal light therapy without focused laser energy. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
Secondary outcomes (8)
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'.
Measured: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
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'.
Measured: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
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.
Measured: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
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'.
Measured: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
Satisfaction with treatment.
Likert scale to describe satisfaction and likelihood of recommending treatment to a friend with a similar condition. Satisfaction is assessed with one question where participants are asked to rank their satisfaction with SoLa Pelvic Therapy on a Likert ordinal scale ranking satisfaction as 'very satisfied', 'satisfied', 'not satisfied', and 'very satisfied'. Likelihood of recommending the therapy to a friend is assessed with a Likert ordinal scale ranking 'very likely', 'somewhat likely', 'not likely', and 'very unlikely'.
Measured: At 1-week after completing treatment.
Adherence with treatment.
Measured as the percentage of completed treatments per participant and percentage of participants who completed 5 or more treatments.
Measured: After 5 treatments are completed.
Need for additional treatment
Questionnaire that collects data on additional pharmacologic or non-pharmacologic, extra-pelvic, pain therapies used during the study duration (excluding laser and physical therapy).
Measured: 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.
Global impression of change
a single, self-administered question asking respondents to rate whether their condition has changed after treatment compared to baseline before treatment. They are asked to select a response based on the following categories: 'very much improved', 'much improved', 'minimally improved', 'no change', 'minimally worse', 'much worse', and 'very much worse'.
Measured: At 1-week after completing treatment, and at 3 months after completing treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start17 Oct 2024
- Primary completion17 Jun 2026
- Study completion17 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Pelvic PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- SoLa Pelvic Therapy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Uroshape LLC
- Responsible party
- Sponsor
- Investigators
- Georgine Lamvu, MD, MPH, Principal investigator, SoLá Pelvic Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673108
- Sponsor's protocol ID
- SoLaPelvicTherapy
- Acronym
- VOICE
- Status last verified
- Oct 2025
- First submitted
- 25 Oct 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data tables may be shared after permission is obtained from the study sponsor.
Publications
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.
PubMed 34841398Zipper 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.
PubMed 33855615
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Photobiomodulation for Chronic Pelvic Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06673108
- Acronym / sponsor ID
- VOICE / SoLaPelvicTherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- SoLa Pelvic TherapyIndustry (pharma, biotech, devices)
- Collaborators
- Uroshape LLC
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 17 Jun 2026 (actual)
- First posted
- 4 Nov 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal photobiomodulation | Active comparator | Device: SoLa Pelvic TherapyVaginal photobiomodulation with near-infrared (810-980nm wavelength) energy. |
| Sham-Light without laser energy. | Sham comparator | Device: ShamVaginal light therapy without focused laser energy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
- Subjectively reports abnormal or decreased sensation in the vagina or rectum;
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 |
|---|---|---|
| SoLa Pelvic TherapyAlso: Low level laser therapySoLá Pelvic Therapy laser emits near-infrared (810-980 nm wavelength) energy to the vaginal tissues. The device treats at 6 W for 3-6 minutes and delivers a fluence of 300-1,600 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. | Device | Vaginal photobiomodulation |
| ShamSham red light WITHOUT focused laser energy. | Device | Sham-Light without laser energy. |
Primary outcome
Overall pelvic pain
Time frame: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
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.
8 secondary outcomes
Symptom specific pelvic pain
Time frame: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
Pain impact
Time frame: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
Quality of life
Time frame: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
Global physical and mental health
Time frame: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
Satisfaction with treatment.
Time frame: At 1-week after completing treatment.
Adherence with treatment.
Time frame: After 5 treatments are completed.
Need for additional treatment
Time frame: 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.
Global impression of change
Time frame: At 1-week after completing treatment, and at 3 months after completing treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- 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.
- Background: PubMed 33855615Zipper 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.
- Individual participant dataSharing planned: Yes. De-identified data tables may be shared after permission is obtained from the study sponsor.
Related trials for Chronic Pelvic Pain
Not yet recruiting
Focused Ultrasound Neuromodulation for Chronic Pain
Chronic Pain, Sickle Cell Disease
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Not yet recruiting
Pregabalin for Chronic Pelvic Pain in Women
Chronic Pelvic Pain, Chronic Pelvic Pain Syndrome
Recruiting
Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
Chronic Pelvic Pain Syndrome, Pelvic Pain
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
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.
Georgine Lamvu, MD, MPH principal investigator
SoLá Pelvic Therapy
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SoLa Pelvic Therapy in people with Chronic Pelvic Pain and Chronic Pelvic Pain Syndrome (CPPS), run by SoLa Pelvic Therapy at 11 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 4 inclusion and 15 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: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall pelvic pain (time frame: At baseline, at 1-week after completing treatment, and at 3 months after completing 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 NCT06673108, which also lists 2 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 25 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.