A Prospective Registry of Vaginal Photobiomodulation for Chronic Pelvic Pain.
ConditionChronic Pelvic Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSoLa Pelvic Therapy
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Selected to receive transvaginal photobiomodulation therapy with the SoLá Pelvic Therapy® as part of their standard clinical care.
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
SoLá Pelvic Therapy (SPT)
DeviceSoLá 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.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Patients Receiving SoLá Pelvic Therapy1 intervention
Trial outcomes
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
SoLa Pelvic Therapy
Lead sponsor
Uroshape LLC
Collaborator
Source ClinicalTrials.gov