At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Pain Using a Non-implanted Intra-vaginal Electrical Stimulation Device Compared to Sham Device in Chronic Pelvic Pain
In Brief
A clinical study evaluating ApexM and Sham Device for Pelvic Pain. Completed, enrolled 58 participants across 1 site.
Detailed Summary
The goal of the study is to evaluate the use of a personal intravaginal, non- implanted electrical stimulation device in the treatment of chronic pelvic pain. The investigators propose a randomized controlled trial comparing the investigated device to a sham device. The primary outcome is pain control using the visual analog scale and brief pain inventory (18). Hypothesis: Subjects will report increased pain relief with the electrical stimulation device compared to those using the sham device alone.
Study Details
Timeline
Interventions
Subjects will apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity is set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. At the target amplitude, patients will feel a non-painful fluttering or tapping sensation, Subjects will perform this for 6 sessions per week at 12 minutes per session for an additional 12 weeks. At each follow-up visit, investigators will re-evaluate the stimulation level and adjust to avoid muscle contraction.
Identical to ApexM but will not deliver any electrical stimulation