Chronic Pelvic Pain
Conditions
Keywords
Chronic Pelvic Pain, Pelvic Pain, Photobiomodulation, Transvaginal Photobiomodulation, SoLá Pelvic Therapy, Pelvic Floor Dysfunction
Brief 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.
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.
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.
Sponsors
SoLa Pelvic Therapy
Uroshape LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Chronic Pelvic Pain Severity | 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. |
Countries
United States
Contacts
CONTACTGeorgine Lamvu, MD, MPH
CONTACTPilar Garcia, MD
Outcome results
None listed