Intra-vaginal Electrical Stimulation Device Compared to Sham Device for Chronic Pelvic Pain

NACompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

June 30, 2017

Study Completion Date

June 30, 2017

Conditions
Pelvic Pain
Interventions
DEVICE

ApexM

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.

DEVICE

Sham Device

Identical to ApexM but will not deliver any electrical stimulation

Trial Locations (1)

44195

Cleveland Clinic Foundation, Cleveland

All Listed Sponsors
lead

The Cleveland Clinic

OTHER

NCT02397785 - Intra-vaginal Electrical Stimulation Device Compared to Sham Device for Chronic Pelvic Pain | Biotech Hunter | Biotech Hunter