ClinicalTrials.gg
RecruitingNCT07799857VOICE RegistryUpdated Sep 2, 2026

A Prospective Registry of Vaginal Photobiomodulation for Chronic Pelvic Pain.

An observational study in Chronic Pelvic Pain, sponsored by SoLa Pelvic Therapy. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by SoLa Pelvic Therapy · Observational

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 151 studies in Pelvic Pain with a site in United States — 36 open to participants now, 39 under way, 1 of them phase 3. Pelvic Pain · United States.

Planned enrollment
4th of 28
1,000 · median 104
Started
2026
with 13 others
Observational
28 of 151
9 open now
Primary completion
2029-04
later than 33 of 38 live
Registered
149th of 151
by date

Among the 151 studies in Pelvic Pain with a site in United States, this one is the 4th largest by planned enrollment of the 28 observational ones, is one of 14 that started in 2026, is one of 28 observational ones, reaches primary completion later than 33 of the 38 other live ones, and was the 149th registered.

By phase

151 studies; the count open now beside each. This study's row is marked.

No phase71 · 22 open
Observationalthis study28 · 9 open
Phase 222 · 0 open
Phase 413 · 2 open
Phase 39 · 1 open
Phase 17 · 2 open
Phase 1/21 · 0 open

By the year they started

First in 1998; this study’s year is marked. 14 started in 2026.

Size and results

Median enrollment 50 across the 123 interventional studies, 104 across the 28 observational. Of the 96 that completed or were terminated, 35 (36%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 151 studies in Pelvic Pain with a site in United States, or all of them as a file.
02

Study 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). 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.

03

Conditions studied

  • Chronic Pelvic Pain

Browse trials for

Keywords

  • Chronic Pelvic Pain
  • Pelvic Pain
  • Photobiomodulation
  • Transvaginal Photobiomodulation
  • SoLá Pelvic Therapy
  • Pelvic Floor Dysfunction
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years or older.
  • Selected to receive transvaginal photobiomodulation therapy with the SoLá Pelvic Therapy® as part of their standard clinical care.

Exclusion criteria

Exclusion Criteria:

- Patients will be excluded from the registry only if the treating healthcare professional determines that SoLá Pelvic Therapy® is not appropriate or .

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • 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.

    Device: SoLá Pelvic Therapy (SPT)

Interventions

  • DeviceSoLá 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline through 12 months

07

Study locations

1 of 1 sites recruiting
  • Zipper Urogynecology Associates
    Melbourne, Florida 32901, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Apr 2029, 36 months after the start.

Of 33 observational studies under Pelvic Pain, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15. This study's planned 36 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2026
First posted
Sep 2, 2026
StartActual
Apr 6, 2026
Primary completionEst.
Apr 2029
CompletionEst.
Apr 2030
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07799857
Lead sponsor
SoLa Pelvic Therapy
Collaborators
Uroshape LLC
Responsible party
Sponsor
First posted
Sep 2, 2026
Start date
Apr 6, 2026
Primary completion
Apr 2029 (estimated)
Completion
Apr 2030 (estimated)
Last update
Sep 2, 2026

Study contacts

Georgine Lamvu, MD, MPH
Contact
georgine@solapelvictherapy.com
407-461-1189
Pilar Garcia, MD
Contact
pilar@solapelvictherapy.com
561-850-1629

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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