Erectile Dysfunction Following Radical ProstatectomyNCT06219785
Low-intensity Shockwave Therapy for Post-radical Prostatectomy Erectile Dysfunction
A study testing Low-Intensity Shockwave therapy (LiSWT) in people with Erectile Dysfunction Following Radical Prostatectomy, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
This research study is trying to determine if Low-Intensity shock wave therapy (LiSWT) is safe and effective in patients with symptoms of erectile dysfunction (ED) after radical prostatectomy. Read more about this study
- Who is it for?
- Ages 45 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- Low-Intensity Shockwave therapy (LiSWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2024to 1 Oct 2024
- 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 45 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men age 45-70 who had robotic prostatectomy within 6 to 18 months
- Documented nerve sparing during radical prostatectomy procedure
- Mild to moderate ED after prostatectomy
- IIEF score > 18 before surgery
- Testosterone level > 300 mg/dl post-surgery
- Sexually active
Who cannot join
- Prior penile surgery
- Lesions or active infections on the penis or perineum
- Anatomical abnormalities in the genitalia or pelvic region
- Unwilling to remove piercing from genital region
- Post radical prostatectomy complications that could impact safety or effectiveness of ESWT (hematoma, unresolved anastomotic leak)
- Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy
- Anticoagulant medication (except acetylsalicylic acid up to 80 mg daily).
- Any other condition that would prevent the patient from completing the study, as judged by the PI
Trial locations and contacts
1 site in 1 country.
About this study
This research study is trying to determine if Low-Intensity shock wave therapy (LiSWT) is safe and effective in patients with symptoms of erectile dysfunction (ED) after radical prostatectomy.
Read the detailed description
Participants will be randomized to the active treatment group or the control/placebo group.
All patients on active treatment will receive Low-Intensity shock wave treatment. Participants assigned to the control group will receive the treatment using a sham applicator. The placebo group will receive the same treatment as the active group, but the transducer used for shock wave treatment will be capped, meaning that no shock waves will be transmitted to the penis.
Participants on active shock wave treatment will receive once a week Low-Intensity shock wave treatments of 0.2 mJ/ mm² over the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis once a week for six weeks, with a total of 6 treatments once a week.
- Being tested
- Low-Intensity Shockwave therapy (LiSWT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Shockwave therapy (LiSWT)Device
Participants will receive once-a-week LiSWT treatments of 0.2 mJ/ mm² over the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis once a week for six weeks, with a total of 6 treatments once a week.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | 1. Patient lies down with legs extended.
2. In order to get a proper transmission, a drop of silicone oil is applied on the anatomical stand-off before putting the ring.
3. Connect the headpiece to the ring.
4. Apply ultrasound gel for proper energy transmission on the shaft of the penis
5. 1500 shocks to the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis
6. Duration of the procedure: approximately 30 minutes Receives: Device: Low-Intensity Shockwave therapy (LiSWT) |
| Control | Sham comparator | 1. Patient lies down with legs extended.
2. In order to get a proper transmission, a drop of silicone oil is applied on the anatomical stand-off before putting the ring.
3. Connect the headpiece to the ring.
4. Apply ultrasound gel for proper energy transmission on the shaft of the penis
5. 1500 shocks to the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis
6. Duration of the procedure: approximately 30 minutes Receives: Device: Low-Intensity Shockwave therapy (LiSWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the International Index of Erectile Function questionnaire.
The International Index of Erectile Function is a multidimensional scale that can be used to evaluate ED. It addresses the most relevant aspects of male sexual function. It involves five questions with a scale report from 0 to 5, 5 being the best value.
Measured: 4 months
To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the Erectile Hardness Score questionnaire.
The Erection Hardness Score is a self-reported tool that measures the hardness of an erection.
It involves a scale report from 0 to 4, 4 being the best quality of erection.
Measured: 4 months
Secondary outcomes (2)
To determine whether LiSWT improves the Peak systolic velocity in the Duplex Doppler Ultrasound.
A hemodynamic parameter commonly used in Duplex Doppler Ultrasound is Peak systolic velocity. A value of 30 cm/s or greater indicates arterial competence. The higher the parameters, the better the response to the therapy.
Measured: 4 months
To determine whether LiSWT improves the Resistive index in the Duplex Doppler Ultrasound.
The second hemodynamic parameter commonly used in Duplex Doppler Ultrasound is the Resistive Index. A value greater than 0.90% would indicate a state of normality. The higher the parameters, the better the response to the therapy.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start10 Jan 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Why it stopped: Since the study opened for enrollment on June 6, 2023, we have enrolled only 5 participants, despite our goal of 100 participants over an 18-month period. Several factors have contributed to this decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Following Radical ProstatectomyStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- Following completion of the 3-month follow-up visit, subjects will be unblinded. Subjects who received the Placebo/control treatment will be offered treatment using the active device applicator.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Miles, The Methodist Hospital Research Institute
- Investigators
- Brian J. Miles, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219785
- Sponsor's protocol ID
- Pro00037405
- Status last verified
- Oct 2024
- First submitted
- 8 Sep 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-intensity Shockwave Therapy for Post-radical Prostatectomy Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT06219785
- Acronym / sponsor ID
- Pro00037405
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Since the study opened for enrollment on June 6, 2023, we have enrolled only 5 participants, despite our goal of 100 participants over an 18-month period. Several factors have contributed to this decision.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 23 Jan 2024 (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.
This research study is trying to determine if Low-Intensity shock wave therapy (LiSWT) is safe and effective in patients with symptoms of erectile dysfunction (ED) after radical prostatectomy.
Detailed description
Participants will be randomized to the active treatment group or the control/placebo group.
All patients on active treatment will receive Low-Intensity shock wave treatment. Participants assigned to the control group will receive the treatment using a sham applicator. The placebo group will receive the same treatment as the active group, but the transducer used for shock wave treatment will be capped, meaning that no shock waves will be transmitted to the penis.
Participants on active shock wave treatment will receive once a week Low-Intensity shock wave treatments of 0.2 mJ/ mm² over the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis once a week for six weeks, with a total of 6 treatments once a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Following completion of the 3-month follow-up visit, subjects will be unblinded. Subjects who received the Placebo/control treatment will be offered treatment using the active device applicator.
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: Low-Intensity Shockwave therapy (LiSWT)1. Patient lies down with legs extended. 2. In order to get a proper transmission, a drop of silicone oil is applied on the anatomical stand-off before putting the ring. 3. Connect the headpiece to the ring. 4. Apply ultrasound gel for proper energy transmission on the shaft of the penis 5. 1500 shocks to the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis 6. Duration of the procedure: approximately 30 minutes |
| Control | Sham comparator | Device: Low-Intensity Shockwave therapy (LiSWT)1. Patient lies down with legs extended. 2. In order to get a proper transmission, a drop of silicone oil is applied on the anatomical stand-off before putting the ring. 3. Connect the headpiece to the ring. 4. Apply ultrasound gel for proper energy transmission on the shaft of the penis 5. 1500 shocks to the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis 6. Duration of the procedure: approximately 30 minutes |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men age 45-70 who had robotic prostatectomy within 6 to 18 months
- Documented nerve sparing during radical prostatectomy procedure
- Mild to moderate ED after prostatectomy
- IIEF score > 18 before surgery
- Testosterone level > 300 mg/dl post-surgery
Key exclusion criteria (8 listed)
- Prior penile surgery
- Lesions or active infections on the penis or perineum
- Anatomical abnormalities in the genitalia or pelvic region
- Unwilling to remove piercing from genital region
- Post radical prostatectomy complications that could impact safety or effectiveness of ESWT (hematoma, unresolved anastomotic leak)
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 |
|---|---|---|
| Low-Intensity Shockwave therapy (LiSWT)Participants will receive once-a-week LiSWT treatments of 0.2 mJ/ mm² over the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis once a week for six weeks, with a total of 6 treatments once a week. | Device | Active, Control |
Primary outcome
To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the International Index of Erectile Function questionnaire.
Time frame: 4 months
The International Index of Erectile Function is a multidimensional scale that can be used to evaluate ED. It addresses the most relevant aspects of male sexual function. It involves five questions with a scale report from 0 to 5, 5 being the best value.
To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the Erectile Hardness Score questionnaire.
Time frame: 4 months
The Erection Hardness Score is a self-reported tool that measures the hardness of an erection. It involves a scale report from 0 to 4, 4 being the best quality of erection.
2 secondary outcomes
To determine whether LiSWT improves the Peak systolic velocity in the Duplex Doppler Ultrasound.
Time frame: 4 months
To determine whether LiSWT improves the Resistive index in the Duplex Doppler Ultrasound.
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Since the study opened for enrollment on June 6, 2023, we have enrolled only 5 participants, despite our goal of 100 participants over an 18-month period. Several factors have contributed to this decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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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.
Brian J. Miles, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Shockwave therapy (LiSWT) in people with Erectile Dysfunction Following Radical Prostatectomy, run by The Methodist Hospital Research Institute 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 6 inclusion and 8 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 8 Oct 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 stopped early (reason given: Since the study opened for enrollment on June 6, 2023, we have enrolled only 5 participants, despite our goal of 100 participants over an 18-month period. Several factors have contributed to this decision.). Results are not available in the source record.
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?
To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the International Index of Erectile Function questionnaire. (time frame: 4 months). The study lists 2 primary outcomes in all. 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 8 Oct 2024.