Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction
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Treatments
Details and patient eligibility
About
Researchers are evaluating the efficacy of low intensity shockwave therapy (LISWT) via MoreNova in the treatment of erectile dysfunction (ED).
Full description
ED is broadly defined as the inability to achieve or maintain an erection sufficient for sexual intercourse or activity. Current treatment for ED consists of oral medications, intracavernosal injections and surgically placed penile prosthetics. In the literature this has been described as a Stepwise Approach, offering therapy beginning with the least invasive treatment option.
The goal of LISWT is to restore natural erections and / or improve responses to oral medications (first line therapy).
LISWT for ED is under evaluation in the USA. The European Association of Urology Guidelines on ED were recently updated to include LISWT for men with mild to moderate ED. The energy/pulse used in this application is approximately 10% of the energy used for disintegrating kidney stones; no serious side effects have been reported. Shock wave therapy for diabetic ulcers has recently been approved by the FDA.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- The patient must have given his informed and signed written consent
- The patient is a male
- Between 40 to and including 55 years of age
- The patient has ED for longer than 1 year but less than 5 years.
- The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
- IIEF-EF Domain score of 17-20
- Evidence Based Criteria: Doppler Clinical Exam
Exclusion criteria
- The patient is participating in another study that may interfere with the results or conclusions of this study
- History of radical prostatectomy or extensive pelvic surgery
- Past radiation therapy of the pelvic region within 12 months prior to enrollment
- Recovering from cancer within 12 months prior to enrollment
- Neurological disease which effects erectile function
- Psychiatric disease which effects erectile function
- The patient is taking blood thinners
- History of Diabetes Mellitus
- History of Coronary Artery Disease
- Evidence Based Criteria: Doppler Clinical Exam
- Severe erectile dysfunction with IIEF-EF domain score < 16
Trial design
Primary purpose
Allocation
Interventional model
Masking
6 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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