Erectile DysfunctionNCT03670628
Low Intensity Shockwaves Therapy for the Treatment of Erectile Dysfunction. 12- Month Follow-Up
A study testing Shockwave therapy in people with Erectile Dysfunction, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the shockwave therapy to treat Erectile Dysfunction. Read more about this study
- Who is it for?
- Ages 30 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Shockwave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 12 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be able willing and able to provide informed consent.
- The patient is a male between 30 and 70 years of age (inclusive).
- The patient has erectile dysfunction (ED) based of IIEF scores.
- The patient has been in a stable relationship for over 3 months prior to enrollment.
- 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)
- The patient is suffering from erectile dysfunction lasting for over 6 months and not more than 5 years as per history provided by patient.
- IIEF-EF score between 16 and 25.
- Testosterone level 300-1000 ng/dL within 1 month prior to enrollment. A1C level ≤ 7% within 1 month prior to enrollment
Who cannot join
- 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.
- The patient is under judicial protection (prison or custody).
- The patient is an adult under guardianship.
- The patient refuses to sign the consent.
- History of radical prostatectomy or extensive pelvic surgery.
- Evidence of venous leak.
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- Past radiation therapy of the pelvic region within 12 months prior to enrollment.
- Recovering from any cancer within 12 months prior to enrollment.
- Neurological disease such as Alzheimers or Parkinson's disease which affects erectile function at the discretion of the investigator.
- Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications at the discretion of the investigator.
- Anatomical malformation of the penis, including Peyronie's disease.
- Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment.
- A1C level > 7% within 1 month prior to enrollment or history of Insulin dependent diabetes.
- The patient is taking blood thinners and has an international normalized ratio >3.
- Received shockwave treatment at least 6 months before enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial of Low Intensity Shockwaves for the Treatment of Erectile Dysfunction. 12- Month Follow-Up of a Double-Blinded, Sham-Controlled Study.
The purpose of this study is to evaluate the safety and effectiveness of the shockwave therapy to treat Erectile Dysfunction.
- Conditions
- Erectile Dysfunction
- Being tested
- Shockwave therapy, Sham shockwave therapy
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave therapyDevice
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 shockwave therapyOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 720 shockwave therapy Group | Active comparator | 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) Receives: Device: Shockwave therapy |
| Sham shockwave therapy | Sham comparator | 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). Receives: Other: Sham shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores.
The IIEF-EF questionnaire has a total score ranging from 0 - 30 with the higher score indicating better erectile function.
Measured: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Secondary outcomes (2)
Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire
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.
Measured: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Erection Hardness Score (EHS)
EHS has a total score ranging from 0 - 4 with the higher score indicating a better erection hardness
Measured: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 May 2019
- Primary completion12 Nov 2021
- Study completion12 Nov 2021
Why it stopped: Due to COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ranjith Ramasamy, MD, University of Miami
- Investigators
- Ranjith Ramasamy, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670628
- Sponsor's protocol ID
- 20180651
- Other IDs
- 20181840
- Status last verified
- Jun 2023
- First submitted
- 10 Sep 2018
- Last updated
- 10 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Low Intensity Shockwaves for the Treatment of Erectile Dysfunction. 12- Month Follow-Up of a Double-Blinded, Sham-Controlled Study.
- ClinicalTrials.gov ID
- NCT03670628
- Acronym / sponsor ID
- 20180651
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 Pandemic
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Posted 10 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of the shockwave therapy to treat Erectile Dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 720 shockwave therapy Group | Active comparator | Device: Shockwave therapyParticipants 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) |
| Sham shockwave therapy | Sham comparator | Other: Sham shockwave therapyParticipants 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). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient must be able willing and able to provide informed consent.
- The patient is a male between 30 and 70 years of age (inclusive).
- The patient has erectile dysfunction (ED) based of IIEF scores.
- The patient has been in a stable relationship for over 3 months prior to enrollment.
- 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)
Key exclusion criteria (15 listed)
- 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.
- The patient is under judicial protection (prison or custody).
- The patient is an adult under guardianship.
- The patient refuses to sign the consent.
- History of radical prostatectomy or extensive pelvic surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shockwave therapyEach 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) | Device | 720 shockwave therapy Group |
| Sham shockwave therapyEach 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) | Other | Sham shockwave therapy |
Primary outcome
International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores.
Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
The IIEF-EF questionnaire has a total score ranging from 0 - 30 with the higher score indicating better erectile function.
2 secondary outcomes
Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire
Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Erection Hardness Score (EHS)
Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ranjith Ramasamy, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave therapy in people with Erectile Dysfunction, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores. (time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.