Chronic Pelvic PainVOICE RegistryNCT07799857
A Prospective Registry of Vaginal Photobiomodulation for Chronic Pelvic Pain.
An observational study of Chronic Pelvic Pain, run by SoLa Pelvic Therapy at 1 site in United States.
Trial summary
The VOICE Registry is a multicenter, prospective, observational registry designed to collect real-world data on the clinical use of SoLá Pelvic Therapy® (SPT) in patients with chronic pelvic pain (CPP). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Pelvic Pain
- What is being tested?
- SoLá Pelvic Therapy (SPT)
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2026to Apr 2030
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adults aged 18 years or older who are selected by their treating healthcare professional to receive transvaginal photobiomodulation with SoLá Pelvic Therapy® as part of standard clinical care. Participants are enrolled from routine clinical practice at participating healthcare sites.
Who may be able to join
- Age 18 years or older.
- Selected to receive transvaginal photobiomodulation therapy with the SoLá Pelvic Therapy® as part of their standard clinical care.
Who cannot join
- Patients will be excluded from the registry only if the treating healthcare professional determines that SoLá Pelvic Therapy® is not appropriate or contraindicated.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Zipper Urogynecology Associates
Melbourne, Florida, 32901
About this study
Official title: A Prospective Registry of Vaginal Photobiomodulation for Chronic Pelvic Pain: The VOICE Registry.
The VOICE Registry is a multicenter, prospective, observational registry designed to collect real-world data on the clinical use of SoLá Pelvic Therapy® (SPT) in patients with chronic pelvic pain (CPP). The registry will follow patients receiving transvaginal photobiomodulation (PBM) therapy with SPT as part of their standard clinical care. The primary purpose of the registry is to collect real-world evidence on the use and safety of SPT.
Read the detailed description
The VOICE Registry is a prospective, multicenter, observational registry designed to evaluate the real-world use of transvaginal photobiomodulation with SoLá Pelvic Therapy® in patients with chronic pelvic pain. Participants receive SoLá Pelvic Therapy® as part of their standard clinical care, independently of participation in the registry.
The registry does not assign treatment or dictate clinical management. Decisions regarding patient selection, treatment frequency, treatment regimen, and concomitant therapies remain at the discretion of the treating healthcare professional. Participants are followed for 12 months from initiation of therapy to collect longitudinal information on device utilization, safety, and patient-reported outcomes.
- Conditions
- Chronic Pelvic Pain
- Being tested
- SoLá Pelvic Therapy (SPT)
- Keywords
- Chronic Pelvic Pain, Pelvic Pain, Photobiomodulation, Transvaginal Photobiomodulation, SoLá Pelvic Therapy, Pelvic Floor Dysfunction
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoLá Pelvic Therapy (SPT)Device
SoLá Pelvic Therapy (SPT) is administered as part of routine clinical care to patients with chronic pelvic pain. Treatment is not assigned by the registry. The registry prospectively collects treatment, and safety information from patients receiving SPT at participating sites.
| Study group | Role | What they receive |
|---|---|---|
| Patients Receiving SoLá Pelvic Therapy | Patients with chronic pelvic pain receiving SoLá Pelvic Therapy (SPT) as part of routine clinical care. Participants are followed prospectively through the registry to collect treatment, use and safety information. Receives: Device: SoLá Pelvic Therapy (SPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Chronic Pelvic Pain Severity
Change in patient-reported pelvic pain severity following SoLá Pelvic Therapy (SPT), assessed using the Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst possible pain). Lower scores indicate less pain.
Measured: Baseline through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start6 Apr 2026
- Primary completionApr 2029 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- SoLa Pelvic Therapy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Uroshape LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799857
- Sponsor's protocol ID
- VOICE-002
- Acronym
- VOICE Registry
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry of Vaginal Photobiomodulation for Chronic Pelvic Pain: The VOICE Registry.
- ClinicalTrials.gov ID
- NCT07799857
- Acronym / sponsor ID
- VOICE Registry / VOICE-002
- Conditions
- Chronic Pelvic Pain
- Keywords
- Chronic Pelvic Pain, Pelvic Pain, Photobiomodulation, Transvaginal Photobiomodulation, SoLá Pelvic Therapy, Pelvic Floor Dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- SoLa Pelvic TherapyIndustry (pharma, biotech, devices)
- Collaborators
- Uroshape LLC
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 2 Sep 2026 (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 VOICE Registry is a multicenter, prospective, observational registry designed to collect real-world data on the clinical use of SoLá Pelvic Therapy® (SPT) in patients with chronic pelvic pain (CPP). The registry will follow patients receiving transvaginal photobiomodulation (PBM) therapy with SPT as part of their standard clinical care. The primary purpose of the registry is to collect real-world evidence on the use and safety of SPT.
Detailed description
The VOICE Registry is a prospective, multicenter, observational registry designed to evaluate the real-world use of transvaginal photobiomodulation with SoLá Pelvic Therapy® in patients with chronic pelvic pain. Participants receive SoLá Pelvic Therapy® as part of their standard clinical care, independently of participation in the registry.
The registry does not assign treatment or dictate clinical management. Decisions regarding patient selection, treatment frequency, treatment regimen, and concomitant therapies remain at the discretion of the treating healthcare professional. Participants are followed for 12 months from initiation of therapy to collect longitudinal information on device utilization, safety, and patient-reported outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving SoLá Pelvic Therapy | – | Device: SoLá Pelvic Therapy (SPT)Patients with chronic pelvic pain receiving SoLá Pelvic Therapy (SPT) as part of routine clinical care. Participants are followed prospectively through the registry to collect treatment, use and safety information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older who are selected by their treating healthcare professional to receive transvaginal photobiomodulation with SoLá Pelvic Therapy® as part of standard clinical care. Participants are enrolled from routine clinical practice at participating healthcare sites.
Key inclusion criteria (2 listed)
- Age 18 years or older.
- Selected to receive transvaginal photobiomodulation therapy with the SoLá Pelvic Therapy® as part of their standard clinical care.
Key exclusion criteria (1 listed)
- Patients will be excluded from the registry only if the treating healthcare professional determines that SoLá Pelvic Therapy® is not appropriate or contraindicated.
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 |
|---|---|---|
| SoLá Pelvic Therapy (SPT)SoLá Pelvic Therapy (SPT) is administered as part of routine clinical care to patients with chronic pelvic pain. Treatment is not assigned by the registry. The registry prospectively collects treatment, and safety information from patients receiving SPT at participating sites. | Device | Patients Receiving SoLá Pelvic Therapy |
Primary outcome
Change in Chronic Pelvic Pain Severity
Time frame: Baseline through 12 months
Change in patient-reported pelvic pain severity following SoLá Pelvic Therapy (SPT), assessed using the Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst possible pain). Lower scores indicate less pain.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pelvic Pain, run by SoLa Pelvic Therapy at 1 site 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgine Lamvu, MD, MPH (407-461-1189, georgine@solapelvictherapy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Chronic Pelvic Pain Severity (time frame: Baseline through 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2026.