A Prospective Registry of Vaginal Photobiomodulation for Chronic Pelvic Pain. (VOICE Registry)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pelvic Pain
• Intervention / Treatment: Device: SoLá Pelvic Therapy (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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Georgine Lamvu, MD, MPH; Phone Number: 407-461-1189; Email: georgine@solapelvictherapy.com
• Study Contact Backup: Name: Pilar Garcia, MD; Phone Number: 561-850-1629; Email: pilar@solapelvictherapy.com

Study Locations

• United States
  • Florida
    • Melbourne, Florida, United States, 32901
      • Recruiting
      • Zipper Urogynecology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline through 12 months

Collaborators and Investigators

• Sponsor: SoLa Pelvic Therapy
• Collaborators: Uroshape LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: August 28, 2026
• First Submitted That Met QC Criteria: September 1, 2026
• First Posted (Actual): September 2, 2026

Study Record Updates

• Last Update Posted (Actual): September 2, 2026
• Last Update Submitted That Met QC Criteria: September 1, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Photobiomodulation; Pelvic Floor Dysfunction; Chronic Pelvic Pain; Pelvic Pain; Transvaginal Photobiomodulation; SoLá Pelvic Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pelvic Pain
• Other Study ID Numbers: VOICE-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No