Low Intensity Shockwaves Therapy for the Treatment of Erectile Dysfunction. 12- Month Follow-Up
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the shockwave therapy to treat Erectile Dysfunction.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 720 shockwave therapy Group Participants in this group will receive a total of 5 daily sessions of shockwave therapy within a week. Each therapy session will consist of 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base) |
Device: Shockwave therapy
Each therapy session, lasting about 20 minutes, will deliver 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
|
| Sham Comparator: Sham shockwave therapy Participants in this group will receive a total of 5 daily sessions of sham shockwave therapy within a week. Sham therapy will be applied to the penis and to the left and right crus (shaft near the base). |
Other: Sham shockwave therapy
Each therapy session, lasting about 20 minutes, will deliver sham shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
|
Outcome Measures
Primary Outcome Measures
- Change in International Index of Erectile Function ( IIEF-EF) Scores [Baseline, Up to 13 months]
The IIEF-EF questionnaire has a total score ranging from 0 - 30 with the higher score indicating better erectile function.
Secondary Outcome Measures
- Number of participants responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire [Up to 13 months]
The SEP consists of two questions: 1) Over the past 4 weeks, were you able to insert your penis into your partner's vagina? and 2) Over the past 4 weeks, did your erection last long enough for you to have successful intercourse? Reported will be the number of participants responding yes to the 2 questions.
- Number of participants responding 'Yes' to the Global Assessment Question (GAQ) [Up to 13 months]
The GAQ consists of two questions: 1) Over the past 4 weeks, has the treatment you have been taking improved your erectile function? and 2) If yes, has the treatment improved your ability to engage in sexual activity over the past 4 weeks? Reported will be the number of participants responding yes to the 2 questions.
- Change in Erection Hardness Score (EHS) [Baseline, Up to 13 months]
EHS has a total score ranging from 0 - 4 with the higher score indicating a better erection hardness
Eligibility Criteria
Criteria
Inclusion Criteria:
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• The patient must be able willing and able to provide informed consent.
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The patient is a male between >30 and <70 years of age.
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The patient has ED based of IIEF scores.
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The patient has been in a stable relationship for over 3 months prior to enrollment.
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A minimum of 2 sexual attempts per month for at least one month prior to enrollment - as documented by International Index of Erectile Dysfunction (IIEF)
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The patient is suffering from erectile dysfunction lasting for over 6 months and not more than 5 years as per history provided by patient.
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IIEF-EF score between 16 and 25.
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Testosterone level 300-1000 ng/dL within 1 month prior to enrollment. A1C level ≤ 7% within 1 month prior to enrollment
Exclusion Criteria:
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The patient is currently or has participated in another study within the past three months that may interfere with the results or conclusions of this study.
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The patient is under judicial protection (prison or custody).
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The patient is an adult under guardianship.
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The patient refuses to sign the consent.
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History of radical prostatectomy or extensive pelvic surgery.
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Evidence of venous leak.
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Past radiation therapy of the pelvic region within 12 months prior to enrollment.
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Recovering from any cancer within 12 months prior to enrollment.
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Neurological disease such as Alzheimers or Parkinson's disease which affects erectile function at the discretion of the investigator.
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Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications at the discretion of the investigator.
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Anatomical malformation of the penis, including Peyronie's disease.
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Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment.
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A1C level > 7% within 1 month prior to enrollment or history of Insulin dependent diabetes.
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The patient is taking blood thinners and has an international normalized ratio >3.
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Received shockwave treatment at least 6 months before enrollment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami | Miami | Florida | United States | 33136 |
Sponsors and Collaborators
- University of Miami
Investigators
- Principal Investigator: Ranjith Ramasamy, MD, University of Miami
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20180651
- 20181840