A Prospective Registry of Vaginal Photobiomodulation for Chronic Pelvic Pain.

Part of paid clinical trials in Melbourne, Florida.

Sponsor
SoLa Pelvic Therapy
Study ID
NCT07799857
Status
Recruiting
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Conditions

  • Chronic Pelvic Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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.

Key Dates

First listed
Sep 2, 2026
Start date
Apr 6, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2030

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Change in Chronic Pelvic Pain Severity [ Time Frame: Baseline through 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Zipper Urogynecology AssociatesMelbourneFlorida32901-

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Zipper Urogynecology Associates· Melbourne, FL

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