Erectile DysfunctionNCT06152146
Clinical Trial of Low Intensity Shockwaves Therapy for Erectile Dysfunction Post-Radical Prostatectomy
A study testing Shockwave Therapy in people with Erectile Dysfunction, run by University of Miami at 1 site in United States.
Trial summary
Research study designed to learn about and compare Shockwave therapy (SWT) vs placebo (no shockwaves) treatment in men with moderate to severe erectile dysfunction (ED) after Radical Prostatectomy Read more about this study
- Who is it for?
- Ages 40 to 75 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to provide informed consent.
- Be male
- Be ≥ 40 and ≤ 75 years of age (inclusive).
- Undergo radical prostatectomy for prostate cancer (nerve sparing or non-nerve sparing without neoadjuvant chemotherapy or radiation therapy.)
- Be at least six weeks post radical prostatectomy.
- Be in a stable sexual relationship for over 3 months prior to enrollment.
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- Have testosterone level of 300-1000 ng/dL within 1 month prior to enrollment.
- Have an HbA1c level ≤ 7% within 3 months prior to enrollment.
- Have undetectable PSA value at the time of enrollment
Who cannot join
- Be currently participating in a clinical trial or have recently received an investigational therapy within the past 30 days that may interfere with the results of this study.
- Be under judicial protection (prison or custody).
- Be an adult under guardianship.
- Refuse to sign the informed consent.
- Have evidence of venous leak prior to surgery or use of PDE5i prior to surgery
- Have past radiation therapy of the pelvic region or hormonal therapy with androgen deprivation within 12 months prior to enrollment.
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- Be recovering from any cancer within 12 months prior to enrollment (other than prostate cancer)
- Have Neurological disease such as Alzheimer's or Parkinson's disease which affects erectile function (at the discretion of the investigator).
- Have a Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications (at the discretion of the investigator).
- Have an anatomical malformation of the penis, including Peyronie's disease.
- Have testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment.
- Be using blood thinners with international normalized ratio (INR) to be > 3.
- Have received shockwave therapy for at least 6 months before enrollment.
- Have detectable PSA value after the radical prostatectomy.
- Require radiation therapy after radical prostatectomy.
- Require hormonal therapy after radical prostatectomy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Desai Sethi Urology Institute - University of Miami, Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: Randomized Controlled Trial of Low Intensity Shockwaves Therapy for the Treatment of Post-Radical Prostatectomy Erectile Dysfunction. SHARP-ED TRIAL
Research study designed to learn about and compare Shockwave therapy (SWT) vs placebo (no shockwaves) treatment in men with moderate to severe erectile dysfunction (ED) after Radical Prostatectomy
- 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 will last about 20 minutes, during which 1,440 shockwaves will be applied to the penis via the left and right crus (shaft near the base)
SHAM shockwave therapyOther
Each therapy session, lasting about 20 minutes, will deliver 1440 SHAM shockwave therapy applied to the penis via the left and right crus (shaft near the base)
| Study group | Role | What they receive |
|---|---|---|
| SWT group | Active comparator | Participants randomized to the treatment group will receive nine (9) shockwave sessions in total: one (1) shockwave session once per week for four (4) weeks, followed by one (1) shockwave session once per month (30±7 days) for the next five (5) months. 1,440 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura) for a total of 12,960 shocks. Participants will be in this group for up to 6 months. Receives: Device: Shockwave Therapy |
| SHAM group | Placebo comparator | Participants randomized to the sham (control) group will have nine (9) sham therapy sessions in total: one (1) sham session once per week for four (4) weeks, followed by one (1) sham session once per month (30±7 days) for the next five (5) months. The shockwave machine will be set to deliver 1,440 shock treatments, but a barrier will be placed around the shockwave probe to ensure that no shockwaves are delivered. Participants will be in this group for up to 6 months. Receives: Other: SHAM shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of participants reporting on Penetrative Intercourse
Number of participants reporting the ability to have penetrative intercourse with or without PDE5i but without the use of intracavernosal injections was chosen as the primary clinical efficacy assessment tool in this study.
Measured: Baseline to 6 months and Baseline to 12 months.
Secondary outcomes (5)
Change in Penile blood flow (Penile Duplex Ultrasound) measured in centimeters per second (cm/sec)
Penile Blood Flow will be reported as Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV), both assessed in cm/sec, via Penile Doppler ultrasonography
Measured: Baseline to 12 months.
Change in IIEF-EF Scores
The International Index of Erectile Function - Erectile Function ( domain score is a patient questionnaire (six questions) used to measure various aspects of erectile performance and assess disease severity in efficacy trials concerning ED. The International Index of Erectile Function - Erectile Function has a minimum score of 0 and max of 30, higher scores mean a better outcome.
Measured: Baseline to 6 months and Baseline to 12 months.
Change in SEP- Sexual Encounter Profile: Questions 2 and 3
The Sexual Encounter Profile (SEP) is a log diary completed after each sexual attempt, providing information as to whether the erection was hard enough to penetrate (SEP 2), or whether it was maintained for completion (SEP 3). Mixed effect linear regression will be used to model post randomization repeated measurements of continuous outcomes. From the results of the model, the mean difference between groups at each time point will be estimated along with a 95% confidence interval.
Measured: Baseline to 6 months and Baseline to 12 months.
Change in GAQ- Global Assessment Questions
The Global Assessment Questions is a measure of perceived improvements in erectile function and sexual ability. It also evaluate improvements in erectile function and ability to engage in sexual activity. The Scoring: GAQ is comprised of two 'yes or no' questions with a total score ranging from 0-2. Categorical data can be obtained from this measure
Measured: Baseline to 6 months and Baseline to 12 months.
Change in EHS- Erection Hardness Score
The Erection Hardness Score (EHS) is a single-item, patient-reported outcome (PRO) for scoring erection hardness. The EHS consists of a single question and the responses are scored from 0-4 with higher scored indicating more erection hardness.
Measured: Baseline to 6 months and Baseline to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start8 Jul 2024 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Why it stopped: Study submission was discarded with the IRB and no longer moving forward
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Russell Saltzman, University of Miami
- Investigators
- Ranjith Ramasamy, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152146
- Sponsor's protocol ID
- 20231090
- Status last verified
- May 2024
- First submitted
- 10 Oct 2023
- Last updated
- 22 May 2024
- Results posted
- No
- 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 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Low Intensity Shockwaves Therapy for the Treatment of Post-Radical Prostatectomy Erectile Dysfunction. SHARP-ED TRIAL
- ClinicalTrials.gov ID
- NCT06152146
- Acronym / sponsor ID
- 20231090
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study submission was discarded with the IRB and no longer moving forward
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 8 Jul 2024 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research study designed to learn about and compare Shockwave therapy (SWT) vs placebo (no shockwaves) treatment in men with moderate to severe erectile dysfunction (ED) after Radical Prostatectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SWT group | Active comparator | Device: Shockwave TherapyParticipants randomized to the treatment group will receive nine (9) shockwave sessions in total: one (1) shockwave session once per week for four (4) weeks, followed by one (1) shockwave session once per month (30±7 days) for the next five (5) months. 1,440 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura) for a total of 12,960 shocks. Participants will be in this group for up to 6 months. |
| SHAM group | Placebo comparator | Other: SHAM shockwave therapyParticipants randomized to the sham (control) group will have nine (9) sham therapy sessions in total: one (1) sham session once per week for four (4) weeks, followed by one (1) sham session once per month (30±7 days) for the next five (5) months. The shockwave machine will be set to deliver 1,440 shock treatments, but a barrier will be placed around the shockwave probe to ensure that no shockwaves are delivered. Participants will be in this group for up to 6 months. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be willing and able to provide informed consent.
- Be male
- Be ≥ 40 and ≤ 75 years of age (inclusive).
- Undergo radical prostatectomy for prostate cancer (nerve sparing or non-nerve sparing without neoadjuvant chemotherapy or radiation therapy.)
- Be at least six weeks post radical prostatectomy.
Key exclusion criteria (16 listed)
- Be currently participating in a clinical trial or have recently received an investigational therapy within the past 30 days that may interfere with the results of this study.
- Be under judicial protection (prison or custody).
- Be an adult under guardianship.
- Refuse to sign the informed consent.
- Have evidence of venous leak prior to surgery or use of PDE5i prior to 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 will last about 20 minutes, during which 1,440 shockwaves will be applied to the penis via the left and right crus (shaft near the base) | Device | SWT group |
| SHAM shockwave therapyEach therapy session, lasting about 20 minutes, will deliver 1440 SHAM shockwave therapy applied to the penis via the left and right crus (shaft near the base) | Other | SHAM group |
Primary outcome
Change in number of participants reporting on Penetrative Intercourse
Time frame: Baseline to 6 months and Baseline to 12 months.
Number of participants reporting the ability to have penetrative intercourse with or without PDE5i but without the use of intracavernosal injections was chosen as the primary clinical efficacy assessment tool in this study.
5 secondary outcomes
Change in Penile blood flow (Penile Duplex Ultrasound) measured in centimeters per second (cm/sec)
Time frame: Baseline to 12 months.
Change in IIEF-EF Scores
Time frame: Baseline to 6 months and Baseline to 12 months.
Change in SEP- Sexual Encounter Profile: Questions 2 and 3
Time frame: Baseline to 6 months and Baseline to 12 months.
Change in GAQ- Global Assessment Questions
Time frame: Baseline to 6 months and Baseline to 12 months.
Change in EHS- Erection Hardness Score
Time frame: Baseline to 6 months and Baseline to 12 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- 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 9 inclusion and 16 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: withdrawn, as of the sponsor's last update on 22 May 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in number of participants reporting on Penetrative Intercourse (time frame: Baseline to 6 months and Baseline to 12 months.). 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 22 May 2024.