Intra-vaginal Electrical Stimulation Device Compared to Sham Device for Chronic Pelvic Pain
Completed · Not applicable · Has a placebo group
Conditions studied: Pelvic Pain
In brief
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.
Key facts
- Study ID
- NCT02397785
- Run by
- The Cleveland Clinic
- People needed
- 58
- Starts
- 2015-04-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2019-07-26
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women >/= 18 years old who are sexually active or desire to be sexually active, no active infection, diagnosed with non-cyclic chronic pelvic pain, duration of symptoms greater than 6 months, neurologically intact, able to accommodate and tolerate the device, not pregnant and not attempting to achieve pregnancy.
You may not qualify if…
- Pregnancy, currently active in pelvic floor physical therapy, active malignancy, patients unable to contract their pelvic floor secondary to causes such as myelopathy, spinal cord trauma, patients with diabetes, vestibulodynia, vulvodynia, a pacemaker, defibrillator or other implanted neuro-modulatory devices, patients with a hypotonic pelvic floor, or those currently on treatment for pain with topical lidocaine, gabapentin or other medications or injections outside of standard analgesics, and severe psychiatric disorders
Where it is running
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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