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NCT04434352 · ClinicalTrials.gov registry record · NA
Low Intensity Shockwave Therapy for Erectile Dysfunction
A NA study of Erectile Dysfunction and Erectile Dysfunction Following Radical Prostatectomy, sponsored by University of Virginia.
- Active
- Registry status
- NA
- Development phase
- 338
- Enrollment target
- 1
- Study location
NCT04434352: Active NA study of Erectile Dysfunction and Erectile Dysfunction Following Radical Prostatectomy, sponsored by University of Virginia.
NCT04434352 is a NA study of Erectile Dysfunction and Erectile Dysfunction Following Radical Prostatectomy that is active but no longer recruiting, run by University of Virginia. The registered enrollment target is 338 participants, above the 221-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (53% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04434352, a NA study of Erectile Dysfunction and Erectile Dysfunction Following Radical Prostatectomy, is active but no longer recruiting, sponsored by University of Virginia.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 338 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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: 1. How do you rate your confidence that you could keep an erection? 2. When you had erections with sexual stimulation, how often were your erections hard enough for penetration (entering your partner)? 3. Duri
Conditions Studied
Interventions
- DEVICE Storz Duolith Low-Intensity Shockwave Therapy
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 338 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2025-01-09 |
| Phase | NA |
What the registry record for NCT04434352 still lists
NCT04434352 is an interventional study that assigns participants to a tested intervention. The registered 338 participants enrollment target is mid-sized for trials with a published cap, above the 221-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (53% higher).
The record links to 5 conditions, with Erectile Dysfunction appearing as the primary indexed condition, and to 1 intervention - of which Storz Duolith Low-Intensity Shockwave Therapy is the first listed.
NCT04434352 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT04434352 about?
NCT04434352 is a clinical study titled "Low Intensity Shockwave Therapy for Erectile Dysfunction". 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 America...
What is the current status of trial NCT04434352?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 338 participants. The study started on 2020-06-01. Estimated completion is 2025-01-09.
What conditions does trial NCT04434352 study?
This clinical trial studies the following conditions: Erectile Dysfunction, Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction Following Radiation Therapy, Erectile Dysfunction Due to General Medical Condition.
What interventions are being tested in trial NCT04434352?
The interventions under investigation include: Storz Duolith Low-Intensity Shockwave Therapy (DEVICE).
Who is sponsoring clinical trial NCT04434352?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04434352 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04434352's enrollment target sits among peer trials
338 6th of 33 higher than 28 of 33 other Erectile Dysfunction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Erectile Dysfunction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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