University Hospitals (UH) Case Medical Center is conducting the first ever pilot study to test a new procedure using "heat therapy" or local radiofrequency energy to treat premature ejaculation. The procedure is called image-guided neurothermal modulation, referring to the energy produced by radio waves directed with a probe to modulate or lessen the sensation of a nerve.
Premature ejaculation (PE) affects 20 percent to 38 percent of men, making it the most common male sexual dysfunction worldwide. Current options available for PE treatment are limited and include oral medication, such as selective serotonin reuptake inhibitors, which can have side-effects throughout the body over long-term use, topical anesthetics and/or behavioral therapies.
"We're very excited that this is the first study of its kind in the world," said J. David Prologo, M.D., primary investigator and UH interventional radiologist. "This is a fairly common condition for which men have limited options. If we can show that local therapy can help, it will provide an outpatient option for symptom control that has eluded men with this condition forever."
In this novel study, patients will undergo CT imaging to guide a tiny electrode about the size of a needle to the dorsal penile nerve in the pelvis, which ultimately supplies nerve sensation to the skin of the penis. Radio waves will be intermittently transmitted through the electrode to lessen the sensation carried by the targeted nerve. The patients will be in a conscious sedation during the procedure, much like the sedation given for a colonoscopy.
UH expects to enroll its first patient in the study in early March. Twenty-two patients will be enrolled in the study to test the safety of the procedure and to see if the procedure results in the expected benefits for patients. The study is funded by Neurotherm®, in cooperation with University Hospitals Case Medical Center.
The procedure will be done on an outpatient basis and patients can go home the same day. The actual procedure only takes about 20 minutes, but there is preparation time prior to the procedure and observation time afterwards.
Dr. Prologo, who is also Assistant Professor in the Division of Vascular and Interventional Radiology at Case Western Reserve University School of Medicine, said that the nerve recovers over time from the procedure, so the effects of the treatment are not permanent. If the effects are beneficial, the next step for study will be permanent ablation.
Ablation is commonly used for pain control, in patients with back problems for example. In addition, the evolution and advances in image guidance have given interventional radiologists the ability to target internal structures for needle interventions with exquisite precision.