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NCT Number: NCT07799857

A Prospective Registry of Vaginal Photobiomodulation for Chronic Pelvic Pain.

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.

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Key information

Conditions

Chronic Pelvic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Zipper Urogynecology Associates

Melbourne, Florida, 32901, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Georgine Lamvu, MD, MPH

CONTACT

[email protected]

407-461-1189

Pilar Garcia, MD

CONTACT

[email protected]

561-850-1629

Sponsors and collaborators

Lead sponsor

SoLa Pelvic Therapy

Industry

Collaborators

  • Uroshape LLC

Registry information

Official study title

A Prospective Registry of Vaginal Photobiomodulation for Chronic Pelvic Pain: The VOICE Registry.

Acronym: VOICE Registry

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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