Erectile Dysfunction Clinical Trial
Official title:
Low Intensity Shockwave Therapy for Erectile Dysfunction
Verified date | May 2024 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Low-intensity shockwave therapy (LiSWT) has been deemed "a safe and well-tolerated procedure but its efficacy for the treatment of ED is doubtful and deserves more investigation" by the European Society of Sexual Medicine. In a similar manner, the Sexual Medicine Society of North America and American Urological Association have put forth guideline statements recommending additional investigation of this treatment modality.2 The current clinical armamentarium only treats the symptoms of erectile dysfunction without improving upon the underlying pathophysiology. LiSWT has been used effectively in musculoskeletal disorders and cardiovascular applications. Animal studies have shown improvements in angiogenesis and stem cell recruitment in other systems (cardiac and musculoskeletal) using shockwave therapy. It has been used to treat erectile dysfunction since 2010 and is widely used in Europe and throughout the world. It is gaining widespread acceptance in the United States with a relative paucity of data in regards to its effectiveness. While the majority of studies and meta-analyses show improvements in standardized erectile dysfunction questionnaires (IIEF/SHIM-Sexual Health Inventory in Men, International Index of Erectile Function-5) the durability remains unknown and many have lacked a sham-arm. In addition, many studies have failed to assess a population of men who have highly prevalent erectile dysfunction, those men undergoing prostate cancer treatment. This is a prospective, randomized, single blind, sham-controlled clinical study aimed to evaluate the safety and efficacy of low-intensity shockwave therapy (LiSWT) on symptomatic ED patients in three distinct patient populations. LiSWT has shown the potential to improve baseline erectile function but requires further study, which is the aim of this investigation.
Status | Active, not recruiting |
Enrollment | 338 |
Est. completion date | January 9, 2025 |
Est. primary completion date | December 10, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 30 Years to 80 Years |
Eligibility | Inclusion Criteria: - The patient must be willing and able to provide informed consent. - The patient is a male between >30 and <80 years of age. - PDE5i responsive or non-responsive. If on PDE5i patient will discontinue medication for 2 weeks before baseline IIEF. - Baseline IIEF-EF score = 8 and =21. If taking PDE5i, stop medication for at least 4 weeks before baseline IIEF. - Testosterone level > 300 ng/dL. This includes patients on therapeutic testosterone therapy. - If diabetic, HgbA1C level = 7.5% within 3 months prior to enrollment. - Men who have undergone radical prostatectomy = 12 months ago - Men who have undergone radiation therapy, either brachytherapy or external bean therapy = 12 months ago Exclusion Criteria: - History of extensive pelvic surgery ever. - Past radiation therapy of the pelvic region within 12 months prior to enrollment. - Recovering from any non-prostate related cancer within 12 months prior to enrollment. - Neurological disease which affects erectile function at the discretion of the investigator. - Anatomical malformation of the penis, including Peyronie's disease. - Testosterone level <300 within 3 month prior to enrollment. - HgbA1C level > 7.5% within 3 month prior to enrollment. - History of spinal cord injury. - Recovering from any non-prostate cancer malignancy within 12 months prior to enrollment. |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in IIEF/SHIM score (International Index of Erectile-Function-5, Sexual Health Inventory in Men) Score at 1 month post-treatment | The primary outcome will be change in (International Index of Erectile-Function-5, Sexual Health Inventory in Men) score from baseline (pre-treatment) to 1 month after the end of treatment. The IIEF/SHIM score is a validated instrument to assess erectile function.
Over the past 6 months: How do you rate your confidence that you could keep an erection? When you had erections with sexual stimulation, how often were your erections hard enough for penetration (entering your partner)? During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner? During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse? When you attempted sexual intercourse, how often was it satisfactory for you? Each item is scored 1-5, with a higher number indicating better rigidity. |
1 month | |
Secondary | Changes in (International Index of Erectile-Function-5, Sexual Health Inventory in Men) at 3 and 6 months post-treatment | Changes in SHIM score (Sexual Health Inventory in Men) score at 3 and 6 months post-treatment.
• The IIEF classifies men into groups of no erectile dysfunction, mild, mild to moderate, moderate and severe erectile dysfunction. Changes in the classifications will be compared between arms at 1, 3, and 6 months post-treatment. |
3 and 6 months | |
Secondary | Adverse Event Rates | Adverse Events including bruising and pain. | 1, 3 and 6 months | |
Secondary | Change in Erection Hardness Score at 1, 3, and 6 months | Change in Erection Hardness Score
The Erection Hardness score is another tool to evaluate erectile function and firmness. It is scored as follows: 0-Penis does not enlarge Penis is larger, but not hard Penis is hard, but not hard enough for penetration Penis is hard enough for penetration, but not completely hard Penis is completely hard and fully rigid A higher score indicates a higher degree of erectile rigidity. |
1, 3, and 6 months |
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