Erectile DysfunctionsNCT06600893
Sham-Controlled Prospective Study Characterizing Erectile Tissue Ultrasound Changes Resulting From Penile LiSWT
A study testing Low intensity shockwave therapy (LiSWT) in people with Erectile Dysfunctions, run by San Diego Sexual Medicine at 1 site in United States.
Trial summary
The primary goal of this single blind, prospective sham-controlled clinical trial is to assess safety and efficacy of low intensity shockwave therapy (LiSWT) to improve erectile function in men 21-80 years of age with erectile dysfunction naive to radial ballistic acoustic wave and LiSWT. Read more about this study
- Who is it for?
- Ages 21 to 80 years, men only
- Conditions the study is for
- Erectile Dysfunctions
- 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
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2019to 7 Apr 2023
- 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 21 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject provides written informed consent and HIPAA authorization before any study procedures are conducted;
- Subject is male;
- Subject is aged 21-80 years;
- Subject is in a relationship with a female partner for at least 3 months;
- Subject has a body mass index (BMI) \< 37 kg/m2;
- Subject has erectile dysfunction;
Show all 11Show fewer
- Subject has testosterone ≥ 300;
- Subject has a prostate specific antigen (PSA) \< 4.0;
- Subject is willing to attempt sexual activity at least 4 times during the screening period and 4 weeks before each follow-up visit;
- Subject is willing to stop all erectile function aids (e.g. prescription and non-prescription medications, injections, vacuum erection devices, constriction ring) during the screening period and 4 weeks before each follow-up visit;
- Subject agrees to comply with the study procedures and visits.
Who cannot join
- Subject has been treated with acoustic wave previously;
- Subject has a pacemaker or implanted defibrillator;
- Subject has clinically significant findings on physical examination;
- Subject has sciatica or severe back pain;
- Subject has uncontrolled hypertension;
- Subject has uncontrolled hypogonadism;
Show all 17Show fewer
- Subject is unwilling to maintain testosterone replacement therapy if currently using testosterone to treat hypogonadism;
- Subject scores ≥ 26 on the IIEF;
- Subject has homogenous corpora cavernosa on grey scale ultrasound;
- Subject has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes him ineligible for the study;
- Subject has lesions or active infections on the penis or perineum;
- Subject is unwilling to remove piercings from the genital region;
- Subject has a history of substance abuse within 12 months prior, or consuming \> 14 alcoholic drinks per week;
- Subject has received an investigational drug within 30 days prior to signing consent;
- Subject has received platelet rich plasma (PRP) within 3 months of signing consent;
- Subject has received stem cell within 6 months of signing consent;
- Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego Sexual Medicine
San Diego, California, 92120
About this study
Official title: A Single-Blind, Sham-Controlled, Randomized, Prospective Study Characterizing Erectile Tissue Ultrasound Changes Resulting From Low Intensity Penile Shockwave Treatment With Urogold 100™
The primary goal of this single blind, prospective sham-controlled clinical trial is to assess safety and efficacy of low intensity shockwave therapy (LiSWT) to improve erectile function in men 21-80 years of age with erectile dysfunction naive to radial ballistic acoustic wave and LiSWT. The main questions it aims to answer are:
- Does homogeneity/inhomogeneity of corporal cavernosal tissue improve using Grayscale ultrasound (GUS) when comparing sham to active treatment groups?
- Do peak systolic velocity (PSV) and end diastolic velocity (EDV) improve using color duplex Doppler ultrasound when comparing sham to active treatment groups?
- Do the International Index of Erectile Function (IIEF), its erectile function domain (IIEF-EF) and question 3 of the Sexual Encounter Profile (SEP) improve comparing sham to active treatment groups?
Read the detailed description
This is a single site sham-controlled clinical trial to be conducted at San Diego Sexual Medicine in San Diego, California. Subjects meeting inclusion and exclusion criteria will be randomized to one of two arms, each 2:1 active to sham, treated in 3-week cycles. Arm 1 consists of 5000 shocks the first week and two weeks off for each of three treatment cycles. Arm 2 is made up of 5000 shocks the first week and 3000 active shocks the second and third weeks followed by three weeks without treatment, and then 5000, 3000 and 3000 shocks again over the next three weeks. Each of these is followed by the first follow-up visit at 20 weeks after the first treatment, when GUS and DUS is repeated and validated instruments completed, at which time treatment will be unblinded. SEP diaries will be completed during sexual activity in the screening period and during the 4 weeks prior to the follow up visit. Those subjects assigned to sham will be crossed over to the opposite arm for active treatment (arm 1 sham goes to arm 2 open label and arm 2 sham to arm 1 open label) and begin active treatment with decreased intervals between shocks and therefore decreased number of shocks needed, with 3500 rather than 5000 shocks and 2000 rather than 3000 shocks at a lower frequency at that visit after completing the follow up procedures. Subjects assigned initially to the active arm will have a second follow up 32 weeks after the first treatment, and complete SEP diaries during the 4 weeks preceding this visit. GUS and DUS is performed and validated instruments completed at the last follow up.
- Conditions
- Erectile Dysfunctions
- Being tested
- Low intensity shockwave therapy (LiSWT), Sham
- Keywords
- low intensity shockwave therapy, erectile dysfunction, grayscale ultrasound, duplex Doppler ultrasound, erectile tissue homogeneity/inhomogeneity
- Medical subject headings
- Erectile Dysfunction
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
Also called SoftWave TRT/UroGold 100MTS, Parabolic applicator OP 155
The Urogold100™ uses electrohydraulic technology to generate low intensity shockwave energies in ranges of 0.1 - 0.18 mJ/mm2 (using 0.9 - 0.12 mJ/mm2 in this study) associated with biologic activities of stimulation of mechanosensors, activation of neo-angiogenesis processes, recruitment and activation of stem cell progenitor cells, improvement of microcirculation, nerve regeneration, remodeling of erectile tissue with increase in the muscle/collagen ratio and reducing inflammatory and cellular stress responses. The device uses the parabolic applicator OP 155 that generates a plasma-driven detonation resulting in a shockwave with a broad and widely-stretched 5 megapascal therapeutic volume. Due to the absence of a concentrated focus, a 14 mm wide shockwave is delivered to the erectile tissue with up to 30 mm penetration. LiSWT is delivered to Active Arms 1 and 2 per protocol. After unblinding at the first follow up visit, participants in Sham Arms 1 and 2 receive active LiSWT treatment
ShamDevice
With the Urogold 100 turned on and with the participant wearing headphones and blinded by a pulled curtain the applicator is applied in a similar manner to when it is active treatment and the sound of shockwave playing in a blue tooth speaker the participant believes he is receiving active treatment but zero energy is delivered.
| Study group | Role | What they receive |
|---|---|---|
| Sham Arm 1-Simulated Low Intensity Shockwave Therapy | Sham comparator | Using the shockwave device, 5000 simulated low intensity shockwave therapy delivered week 0, week 3, week 6 Receives: Device: Sham |
| Active Arm 1- Low Intensity Shockwave Therapy | Experimental | Using the shockwave device, 5000 low intensity shockwave therapy delivered week 0, week 3, week 6 Receives: Device: Low intensity shockwave therapy (LiSWT) |
| Sham Arm 2 - Simulated Low Intensity Shockwave Therapy | Sham comparator | Using the shockwave device, 5000 simulated low intensity shockwave therapy delivered week 0, 3000 week 1, 3000 week 3, 5000 week 6, 3000 week 7, 3000 week 8 Receives: Device: Sham |
| Active Arm 2 - Low Intensity Shockwave Therapy | Experimental | Using the shockwave device, 5000 low intensity shockwave therapy delivered week 0, 3000 week 1, 3000 week 3, 5000 week 6, 3000 week 7, 3000 week 8 Receives: Device: Low intensity shockwave therapy (LiSWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grayscale ultrasound (GUS)
Changes from low intensity shockwave treatment using Grayscale ultrasound to assess erectile tissue homogeneity of the corpora cavernosa comparing sham and active treatment groups
Measured: Baseline to follow up visit 1 at week 20, and follow up visit 2 at week 32 for those assigned initially to the active arm and week 40 to those initially assigned to sham
Duplex Doppler ultrasound (DUS)
Changes from low intensity shockwave treatment in peak systolic velocity (PSV) and end diastolic velocity (EDV) using color duplex Doppler ultrasound comparing sham and active treatment groups
Measured: Baseline to follow up visit 1 at week 20, and follow up visit 2 at week 32 for those assigned initially to the active arm and week 40 to those initially assigned to sham
Secondary outcomes (3)
International Index of Erectile Function (IIEF)
Changes in IIEF, a validated patient reported outcome instrument used to assess sexual function will be compared from baseline to both follow up visit. This has a 4 week recall.
Measured: Baseline to follow up visit 1 at week 20, and follow up visit 2 at week 32 for those assigned initially to the active arm and week 40 to those initially assigned to sham
IIEF Erectile Function Domain (IIEF-EF)
Changes in the erectile function domain, IIEF-EF, used specifically to assess erectile function, will be compared from baseline to both follow up visit. This is a 4 week recall.
Measured: Baseline to follow up visit 1 at week 20, and follow up visit 2 at week 32 for those assigned initially to the active arm and week 40 to those initially assigned to sham
Sexual Encounter Profile (SEP)
The SEP diary is a standard assessment completed by a participant after each attempt at sexual activity.
Measured: Completed over the 4 week screening period, and during the 4 weeks prior to each follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Aug 2019
- Primary completion22 Jun 2022
- Study completion7 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionsStudies 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
- Sham group crosses over to active treatment while active group does a second follow up assessment without additional treatment intervention
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego Sexual Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irwin Goldstein, MD, Principal investigator, San Diego Sexual Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600893
- Sponsor's protocol ID
- SDSM-2019-02.1
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The research is from a small medical practice without the manpower, financial or technical support from a larger institution or industry to enter data into a data repository.
Publications
Kitrey ND, Vardi Y, Appel B, Shechter A, Massarwi O, Abu-Ghanem Y, Gruenwald I. Low Intensity Shock Wave Treatment for Erectile Dysfunction-How Long Does the Effect Last? J Urol. 2018 Jul;200(1):167-170. doi: 10.1016/j.juro.2018.02.070. Epub 2018 Mar 1.
PubMed 29477719Kalyvianakis D, Hatzichristou D. Low-Intensity Shockwave Therapy Improves Hemodynamic Parameters in Patients With Vasculogenic Erectile Dysfunction: A Triplex Ultrasonography-Based Sham-Controlled Trial. J Sex Med. 2017 Jul;14(7):891-897. doi: 10.1016/j.jsxm.2017.05.012.
PubMed 28673433Kalyvianakis D, Memmos E, Mykoniatis I, Kapoteli P, Memmos D, Hatzichristou D. Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment. J Sex Med. 2018 Mar;15(3):334-345. doi: 10.1016/j.jsxm.2018.01.003. Epub 2018 Feb 1.
PubMed 29396020Sokolakis I, Hatzichristodoulou G. Clinical studies on low intensity extracorporeal shockwave therapy for erectile dysfunction: a systematic review and meta-analysis of randomised controlled trials. Int J Impot Res. 2019 May;31(3):177-194. doi: 10.1038/s41443-019-0117-z. Epub 2019 Jan 21.
PubMed 30664671Sokolakis I, Dimitriadis F, Teo P, Hatzichristodoulou G, Hatzichristou D, Giuliano F. The Basic Science Behind Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction: A Systematic Scoping Review of Pre-Clinical Studies. J Sex Med. 2019 Feb;16(2):168-194. doi: 10.1016/j.jsxm.2018.12.016.
PubMed 30770067Rizk PJ, Krieger JR, Kohn TP, Pastuszak AW. Low-Intensity Shockwave Therapy for Erectile Dysfunction. Sex Med Rev. 2018 Oct;6(4):624-630. doi: 10.1016/j.sxmr.2018.01.002. Epub 2018 Mar 22.
PubMed 29576441Ruffo A, Capece M, Prezioso D, Romeo G, Illiano E, Romis L, Di Lauro G, Iacono F. Safety and efficacy of low intensity shockwave (LISW) treatment in patients with erectile dysfunction. Int Braz J Urol. 2015 Sep-Oct;41(5):967-74. doi: 10.1590/S1677-5538.IBJU.2014.0386.
PubMed 26689523Goldstein SW, Kim NN, Goldstein I. Randomized trial of low intensity shockwave therapy for erectile dysfunction utilizing grayscale ultrasound for analysis of erectile tissue homogeneity/inhomogeneity. Transl Androl Urol. 2024 Oct 31;13(10):2246-2267. doi: 10.21037/tau-24-338. Epub 2024 Oct 28.
PubMed 39507857
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Sham-Controlled, Randomized, Prospective Study Characterizing Erectile Tissue Ultrasound Changes Resulting From Low Intensity Penile Shockwave Treatment With Urogold 100™
- ClinicalTrials.gov ID
- NCT06600893
- Acronym / sponsor ID
- SDSM-2019-02.1
- Conditions
- Erectile Dysfunctions
- Keywords
- low intensity shockwave therapy, erectile dysfunction, grayscale ultrasound, duplex Doppler ultrasound, erectile tissue homogeneity/inhomogeneity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- San Diego Sexual MedicineUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 7 Apr 2023 (actual)
- First posted
- 19 Sep 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.
The primary goal of this single blind, prospective sham-controlled clinical trial is to assess safety and efficacy of low intensity shockwave therapy (LiSWT) to improve erectile function in men 21-80 years of age with erectile dysfunction naive to radial ballistic acoustic wave and LiSWT. The main questions it aims to answer are:
- Does homogeneity/inhomogeneity of corporal cavernosal tissue improve using Grayscale ultrasound (GUS) when comparing sham to active treatment groups?
- Do peak systolic velocity (PSV) and end diastolic velocity (EDV) improve using color duplex Doppler ultrasound when comparing sham to active treatment groups?
- Do the International Index of Erectile Function (IIEF), its erectile function domain (IIEF-EF) and question 3 of the Sexual Encounter Profile (SEP) improve comparing sham to active treatment groups?
Detailed description
This is a single site sham-controlled clinical trial to be conducted at San Diego Sexual Medicine in San Diego, California. Subjects meeting inclusion and exclusion criteria will be randomized to one of two arms, each 2:1 active to sham, treated in 3-week cycles. Arm 1 consists of 5000 shocks the first week and two weeks off for each of three treatment cycles. Arm 2 is made up of 5000 shocks the first week and 3000 active shocks the second and third weeks followed by three weeks without treatment, and then 5000, 3000 and 3000 shocks again over the next three weeks. Each of these is followed by the first follow-up visit at 20 weeks after the first treatment, when GUS and DUS is repeated and validated instruments completed, at which time treatment will be unblinded. SEP diaries will be completed during sexual activity in the screening period and during the 4 weeks prior to the follow up visit. Those subjects assigned to sham will be crossed over to the opposite arm for active treatment (arm 1 sham goes to arm 2 open label and arm 2 sham to arm 1 open label) and begin active treatment with decreased intervals between shocks and therefore decreased number of shocks needed, with 3500 rather than 5000 shocks and 2000 rather than 3000 shocks at a lower frequency at that visit after completing the follow up procedures. Subjects assigned initially to the active arm will have a second follow up 32 weeks after the first treatment, and complete SEP diaries during the 4 weeks preceding this visit. GUS and DUS is performed and validated instruments completed at the last follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Sham group crosses over to active treatment while active group does a second follow up assessment without additional treatment intervention
| Arm | Type | Receives |
|---|---|---|
| Sham Arm 1-Simulated Low Intensity Shockwave Therapy | Sham comparator | Device: ShamUsing the shockwave device, 5000 simulated low intensity shockwave therapy delivered week 0, week 3, week 6 |
| Active Arm 1- Low Intensity Shockwave Therapy | Experimental | Device: Low intensity shockwave therapy (LiSWT)Using the shockwave device, 5000 low intensity shockwave therapy delivered week 0, week 3, week 6 |
| Sham Arm 2 - Simulated Low Intensity Shockwave Therapy | Sham comparator | Device: ShamUsing the shockwave device, 5000 simulated low intensity shockwave therapy delivered week 0, 3000 week 1, 3000 week 3, 5000 week 6, 3000 week 7, 3000 week 8 |
| Active Arm 2 - Low Intensity Shockwave Therapy | Experimental | Device: Low intensity shockwave therapy (LiSWT)Using the shockwave device, 5000 low intensity shockwave therapy delivered week 0, 3000 week 1, 3000 week 3, 5000 week 6, 3000 week 7, 3000 week 8 |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject provides written informed consent and HIPAA authorization before any study procedures are conducted;
- Subject is male;
- Subject is aged 21-80 years;
- Subject is in a relationship with a female partner for at least 3 months;
- Subject has a body mass index (BMI) \< 37 kg/m2;
Key exclusion criteria (17 listed)
- Subject has been treated with acoustic wave previously;
- Subject has a pacemaker or implanted defibrillator;
- Subject has clinically significant findings on physical examination;
- Subject has sciatica or severe back pain;
- Subject has uncontrolled hypertension;
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)Also: SoftWave TRT/UroGold 100MTS, Parabolic applicator OP 155The Urogold100™ uses electrohydraulic technology to generate low intensity shockwave energies in ranges of 0.1 - 0.18 mJ/mm2 (using 0.9 - 0.12 mJ/mm2 in this study) associated with biologic activities of stimulation of mechanosensors, activation of neo-angiogenesis processes, recruitment and activation of stem cell progenitor cells, improvement of microcirculation, nerve regeneration, remodeling of erectile tissue with increase in the muscle/collagen ratio and reducing inflammatory and cellular stress responses. The device uses the parabolic applicator OP 155 that generates a plasma-driven detonation resulting in a shockwave with a broad and widely-stretched 5 megapascal therapeutic volume. Due to the absence of a concentrated focus, a 14 mm wide shockwave is delivered to the erectile tissue with up to 30 mm penetration. LiSWT is delivered to Active Arms 1 and 2 per protocol. After unblinding at the first follow up visit, participants in Sham Arms 1 and 2 receive active LiSWT treatment | Device | Active Arm 1- Low Intensity Shockwave Therapy, Active Arm 2 - Low Intensity Shockwave Therapy |
| ShamWith the Urogold 100 turned on and with the participant wearing headphones and blinded by a pulled curtain the applicator is applied in a similar manner to when it is active treatment and the sound of shockwave playing in a blue tooth speaker the participant believes he is receiving active treatment but zero energy is delivered. | Device | Sham Arm 1-Simulated Low Intensity Shockwave Therapy, Sham Arm 2 - Simulated Low Intensity Shockwave Therapy |
Primary outcome
Grayscale ultrasound (GUS)
Time frame: Baseline to follow up visit 1 at week 20, and follow up visit 2 at week 32 for those assigned initially to the active arm and week 40 to those initially assigned to sham
Changes from low intensity shockwave treatment using Grayscale ultrasound to assess erectile tissue homogeneity of the corpora cavernosa comparing sham and active treatment groups
Duplex Doppler ultrasound (DUS)
Time frame: Baseline to follow up visit 1 at week 20, and follow up visit 2 at week 32 for those assigned initially to the active arm and week 40 to those initially assigned to sham
Changes from low intensity shockwave treatment in peak systolic velocity (PSV) and end diastolic velocity (EDV) using color duplex Doppler ultrasound comparing sham and active treatment groups
3 secondary outcomes
International Index of Erectile Function (IIEF)
Time frame: Baseline to follow up visit 1 at week 20, and follow up visit 2 at week 32 for those assigned initially to the active arm and week 40 to those initially assigned to sham
IIEF Erectile Function Domain (IIEF-EF)
Time frame: Baseline to follow up visit 1 at week 20, and follow up visit 2 at week 32 for those assigned initially to the active arm and week 40 to those initially assigned to sham
Sexual Encounter Profile (SEP)
Time frame: Completed over the 4 week screening period, and during the 4 weeks prior to each follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 29477719Kitrey ND, Vardi Y, Appel B, Shechter A, Massarwi O, Abu-Ghanem Y, Gruenwald I. Low Intensity Shock Wave Treatment for Erectile Dysfunction-How Long Does the Effect Last? J Urol. 2018 Jul;200(1):167-170. doi: 10.1016/j.juro.2018.02.070. Epub 2018 Mar 1.
- Background: PubMed 28673433Kalyvianakis D, Hatzichristou D. Low-Intensity Shockwave Therapy Improves Hemodynamic Parameters in Patients With Vasculogenic Erectile Dysfunction: A Triplex Ultrasonography-Based Sham-Controlled Trial. J Sex Med. 2017 Jul;14(7):891-897. doi: 10.1016/j.jsxm.2017.05.012.
- Background: PubMed 29396020Kalyvianakis D, Memmos E, Mykoniatis I, Kapoteli P, Memmos D, Hatzichristou D. Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment. J Sex Med. 2018 Mar;15(3):334-345. doi: 10.1016/j.jsxm.2018.01.003. Epub 2018 Feb 1.
- Background: PubMed 30664671Sokolakis I, Hatzichristodoulou G. Clinical studies on low intensity extracorporeal shockwave therapy for erectile dysfunction: a systematic review and meta-analysis of randomised controlled trials. Int J Impot Res. 2019 May;31(3):177-194. doi: 10.1038/s41443-019-0117-z. Epub 2019 Jan 21.
- Background: PubMed 30770067Sokolakis I, Dimitriadis F, Teo P, Hatzichristodoulou G, Hatzichristou D, Giuliano F. The Basic Science Behind Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction: A Systematic Scoping Review of Pre-Clinical Studies. J Sex Med. 2019 Feb;16(2):168-194. doi: 10.1016/j.jsxm.2018.12.016.
- Background: PubMed 29576441Rizk PJ, Krieger JR, Kohn TP, Pastuszak AW. Low-Intensity Shockwave Therapy for Erectile Dysfunction. Sex Med Rev. 2018 Oct;6(4):624-630. doi: 10.1016/j.sxmr.2018.01.002. Epub 2018 Mar 22.
- Background: PubMed 26689523Ruffo A, Capece M, Prezioso D, Romeo G, Illiano E, Romis L, Di Lauro G, Iacono F. Safety and efficacy of low intensity shockwave (LISW) treatment in patients with erectile dysfunction. Int Braz J Urol. 2015 Sep-Oct;41(5):967-74. doi: 10.1590/S1677-5538.IBJU.2014.0386.
- Derived from this study: PubMed 39507857Goldstein SW, Kim NN, Goldstein I. Randomized trial of low intensity shockwave therapy for erectile dysfunction utilizing grayscale ultrasound for analysis of erectile tissue homogeneity/inhomogeneity. Transl Androl Urol. 2024 Oct 31;13(10):2246-2267. doi: 10.21037/tau-24-338. Epub 2024 Oct 28.
- Individual participant dataSharing planned: No. The research is from a small medical practice without the manpower, financial or technical support from a larger institution or industry to enter data into a data repository.
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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.
Irwin Goldstein, MD principal investigator
San Diego Sexual Medicine
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 Dysfunctions, run by San Diego Sexual Medicine 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 11 inclusion and 17 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: finished, as of the sponsor's last update on 19 Sep 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Grayscale ultrasound (GUS) (time frame: Baseline to follow up visit 1 at week 20, and follow up visit 2 at week 32 for those assigned initially to the active arm and week 40 to those initially assigned to sham). 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?
On the ClinicalTrials.gov record for NCT06600893, which also lists 8 linked publications.
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 19 Sep 2024.