Erectile DysfunctionNCT03642366
Low-intensity Shockwaves Therapy + Tadalafil 5mg for the Treatment of Severe Erectile Dysfunction
A study testing Dornier Aries2 LiST Device + 5mg Tadalafil (1) and Dornier Aries2 LiST Device + 5mg Tadalafil (2) in people with Erectile Dysfunction, run by Institute for the Study of Urological Diseases, Greece at 1 site in Greece.
Trial summary
This is a randomized, double-blind, sham-controlled, 3 parallel arms, clinical trial. All patients will be PDE5I users or ex-users. After 1 month wash-out period, ED patients will be screened, in order to randomize 51 men with vasculogenic ED. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Dornier Aries2 LiST Device + 5mg Tadalafil (1) and Dornier Aries2 LiST Device + 5mg Tadalafil (2)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteGreece
- Study dates
- 27 Aug 2018to Dec 2022
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent to participate.
- Age 40-70 years.
- Sexually active in a stable, heterosexual relationship of more than three months duration.
- Presence of Erectile Dysfunction for at least 6 months.
- At screening, diagnosed as Vasculogenic erectile dysfunction based on sexual history.
- Partial response to highest dose of PDE5i
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- Agree to suspend all other ED therapies, except the assigned study treatments, for the duration of the study.
- Agree to attempt sexual intercourse and document the outcome using the Sexual Encounter Profile (SEP) at least 4 times for the last 4 weeks prior to Visit 2/Randomization, 1 month Follow Up, 3 month Follow Up and 4 month Follow Up without being under the influence of alcohol or recreational drugs. Agree to document the outcome using the Sexual Encounter Profile (SEP) diary.
- IIEF-ED score 1-10 at Visit 2 (after PDE5i washout)
- At Visit 2 (after PDE5i washout), SEP Q2, "Were you able to insert your penis into your partner's vagina?" answered "YES" 0 - 50% of the time.
- At Visit 2, SEP Q3, "Did your erection last long enough for you to have successful intercourse?" answered "YES" 0 - 25% of the time.
Who cannot join
- Previous major pelvic surgery or pelvic trauma that could impact erectile function, such as radical prostatectomy, radical cystectomy, rectal surgery. Patients with previous TURP surgery without sequelae of iatrogenic ED may be included.
- Previous penile surgery of any kind except circumcision and condyloma removal, such as penile lengthening, penile cancer surgery, penile plication, grafting.
- Previous history of priapism or penile fracture
- Previous radiation therapy to pelvis.
- Abnormal serum testosterone level defined as a value lower than 300 ng/dL (indicative of untreated hypogonadism), or greater than 1197 ng/dL.
- Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded.
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- ED due primarily to psychogenic factors.
- Peyronie's Disease or penile curvature that negatively influences sexual activity.
- Patients with cardiac or non-cardiac electrical devices implanted.
- Open wound or any anatomical or neurological abnormalities in the treatment area.
- Uncontrolled diabetes mellitus with glucose >200 mg/dL (once or more times/week during the last month prior to recruitment, or during screening blood test).
- Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson 's disease.
- Refusal to suspend ED therapy for duration of study. Subjects who are using Tadalafil as a treatment for BPH (Benign Prostatic Hyperplasia) will also be excluded.
- Men deemed not healthy enough to participate in sexual activity.
- Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.
- Any health history or laboratory result that indicates to the Principal Investigator that the subject has a significant medical condition and should not participate in the study.
- Known allergy to ultrasound gel. 18,. Any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. Patients who are currently using SSRI or psychotropic medications e.g., Citalopram (Celexa), Escitalopram (Lexapro, Cipralex), Paroxetine (Paxil, Seroxat), Fluoxetine (Prozac), Fluvoxamine (Luvox, Faverin),Sertraline (Zoloft, Lustral), Clonazepam (Klonopin), Alprazolam (Xanax), Aripiprazole (Ambilify), Clozapine (Clozaril), Risperidone (Risperdal), Quetiapine (Seroquel), Olanzapine (Zyprexa) are also excluded.
- 19. Partners who are < 18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have any gynecologic problems, sexual dysfunction, or major medical conditions that would limit participation in sexual intercourse.
- 20. History of adverse events in response to tadalafil, which would prevent patient compliance to the study protocol.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
G.Gennimatas Hospital
Thessaloniki, 54621
Paraskevi Kapoteli, 6948581395 ext. +30, pkapotel@auth.gr
Dimitrios Hatzichristou, Prof.
About this study
Official title: Low-intensity Shockwaves Therapy Co-administered With Tadalafil 5mg for the Treatment of Severe, Vasculogenic Erectile Dysfunction:Validation of an Evidence Based Protocol in a Randomized, Sham-controlled Trial
This is a randomized, double-blind, sham-controlled, 3 parallel arms, clinical trial. All patients will be PDE5I users or ex-users. After 1 month wash-out period, ED patients will be screened, in order to randomize 51 men with vasculogenic ED. Patients will be randomized in 3 groups (17 subjects in each group) to receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), three times a week (total of 4 weeks) without treatment interval. One group will be sham-control at energy level 7 whereas 2 groups will receive active treatment.Three identical standard probes (probes A, B, C) will be used for the study, 2 of them active and one sham. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks. The IIEF-ED domain will be evaluated at Visit 1 and, consequently, at baseline and all follow up visits together with the SEP diaries.
- Conditions
- Erectile Dysfunction
- Being tested
- Dornier Aries2 LiST Device + 5mg Tadalafil (1), Dornier Aries2 LiST Device + 5mg Tadalafil (2), Sham LiST Device + 5mg Tadalafil
- Keywords
- Low Intensity 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.
Dornier Aries2 LiST Device + 5mg Tadalafil (1)Other
Patients will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), three times a week (total of 4 weeks) without treatment interval. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks.
Dornier Aries2 LiST Device + 5mg Tadalafil (2)Other
Patients will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), three times a week (total of 4 weeks) without treatment interval. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks.
Sham LiST Device + 5mg TadalafilOther
Patients will receive sham shockwave treatment (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7)using a sham probe identical to active probes, three times a week (total of 4 weeks) without treatment interval. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks. The IIEF-ED domain will be evaluated at Visit 1 and, consequently, at baseline and all follow up visits together with the SEP diaries.
| Study group | Role | What they receive |
|---|---|---|
| Active Arm 1 | Active comparator | Not described Receives: Other: Dornier Aries2 LiST Device + 5mg Tadalafil (1) |
| Active Arm 2 | Active comparator | Not described Receives: Other: Dornier Aries2 LiST Device + 5mg Tadalafil (2) |
| Sham Arm | Sham comparator | Not described Receives: Other: Sham LiST Device + 5mg Tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the groups in the change of the Erectile Function (EF) domain score of the International Index of Erectile (IIEF)
EF domain of the IIEF questionnaire will be completed.IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction)
Measured: baseline and 12 week follow up visit
Secondary outcomes (6)
The difference between the groups in the change of the Erectile Function (EF) domain score of the International Index of Erectile (IIEF)
EF domain of the IIEF questionnaire will be completed.IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction)
Measured: baseline and 4 week follow up visit
The difference between the groups in the change of the Erectile Function (EF) domain score of the International Index of Erectile (IIEF)
EF domain of the IIEF questionnaire will be completed.IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction)
Measured: baseline and 16 week follow up visit
Change in Sexual Encounter Profile Question 3 (SEP3) score
The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported.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) or a satisfactory sexual experience (SEP 4). SEP 3 exact question is "Did your erection last long enough for you to have successful intercourse?"
Measured: baseline and 4-week follow up visit
Change in Sexual Encounter Profile Question 3 (SEP3) score
The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported.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) or a satisfactory sexual experience (SEP 4). SEP 3 exact question is "Did your erection last long enough for you to have successful intercourse?"
Measured: baseline and 12-week follow up visit
Change in Sexual Encounter Profile Question 3 (SEP3) score
The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported.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) or a satisfactory sexual experience (SEP 4). SEP 3 exact question is "Did your erection last long enough for you to have successful intercourse?"
Measured: baseline and 16-week follow up visit
Number of patients with treatment related adverse events
Potential treatment related adverse events after the first LI-ESWT session and during the 16-weeks follow up period will be reported
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start27 Aug 2018
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
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.
- 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, Care provider
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for the Study of Urological Diseases, Greece
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Hatzichristou, Institute for the Study of Urological Diseases, Greece
- Investigators
- Dimitrios Hatzichristou, Prof., Principal investigator, Institute for the Study of Urological Diseases, Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642366
- Sponsor's protocol ID
- 10673/2018
- Status last verified
- May 2022
- First submitted
- 20 Aug 2018
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-intensity Shockwaves Therapy Co-administered With Tadalafil 5mg for the Treatment of Severe, Vasculogenic Erectile Dysfunction:Validation of an Evidence Based Protocol in a Randomized, Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT03642366
- Acronym / sponsor ID
- 10673/2018
- Conditions
- Erectile Dysfunction
- Keywords
- Low Intensity Shockwave Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Institute for the Study of Urological Diseases, GreeceUniversity, hospital or other
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Aug 2018 (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 is a randomized, double-blind, sham-controlled, 3 parallel arms, clinical trial. All patients will be PDE5I users or ex-users. After 1 month wash-out period, ED patients will be screened, in order to randomize 51 men with vasculogenic ED. Patients will be randomized in 3 groups (17 subjects in each group) to receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), three times a week (total of 4 weeks) without treatment interval. One group will be sham-control at energy level 7 whereas 2 groups will receive active treatment.Three identical standard probes (probes A, B, C) will be used for the study, 2 of them active and one sham. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks. The IIEF-ED domain will be evaluated at Visit 1 and, consequently, at baseline and all follow up visits together with the SEP diaries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Arm 1 | Active comparator | Other: Dornier Aries2 LiST Device + 5mg Tadalafil (1) |
| Active Arm 2 | Active comparator | Other: Dornier Aries2 LiST Device + 5mg Tadalafil (2) |
| Sham Arm | Sham comparator | Other: Sham LiST Device + 5mg Tadalafil |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Consent to participate.
- Age 40-70 years.
- Sexually active in a stable, heterosexual relationship of more than three months duration.
- Presence of Erectile Dysfunction for at least 6 months.
- At screening, diagnosed as Vasculogenic erectile dysfunction based on sexual history.
Key exclusion criteria (19 listed)
- Previous major pelvic surgery or pelvic trauma that could impact erectile function, such as radical prostatectomy, radical cystectomy, rectal surgery. Patients with previous TURP surgery without sequelae of iatrogenic ED may be included.
- Previous penile surgery of any kind except circumcision and condyloma removal, such as penile lengthening, penile cancer surgery, penile plication, grafting.
- Previous history of priapism or penile fracture
- Previous radiation therapy to pelvis.
- Abnormal serum testosterone level defined as a value lower than 300 ng/dL (indicative of untreated hypogonadism), or greater than 1197 ng/dL.
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 |
|---|---|---|
| Dornier Aries2 LiST Device + 5mg Tadalafil (1)Patients will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), three times a week (total of 4 weeks) without treatment interval. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks. | Other | Active Arm 1 |
| Dornier Aries2 LiST Device + 5mg Tadalafil (2)Patients will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), three times a week (total of 4 weeks) without treatment interval. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks. | Other | Active Arm 2 |
| Sham LiST Device + 5mg TadalafilPatients will receive sham shockwave treatment (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7)using a sham probe identical to active probes, three times a week (total of 4 weeks) without treatment interval. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks. The IIEF-ED domain will be evaluated at Visit 1 and, consequently, at baseline and all follow up visits together with the SEP diaries. | Other | Sham Arm |
Primary outcome
The difference between the groups in the change of the Erectile Function (EF) domain score of the International Index of Erectile (IIEF)
Time frame: baseline and 12 week follow up visit
EF domain of the IIEF questionnaire will be completed.IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction)
6 secondary outcomes
The difference between the groups in the change of the Erectile Function (EF) domain score of the International Index of Erectile (IIEF)
Time frame: baseline and 4 week follow up visit
The difference between the groups in the change of the Erectile Function (EF) domain score of the International Index of Erectile (IIEF)
Time frame: baseline and 16 week follow up visit
Change in Sexual Encounter Profile Question 3 (SEP3) score
Time frame: baseline and 4-week follow up visit
Change in Sexual Encounter Profile Question 3 (SEP3) score
Time frame: baseline and 12-week follow up visit
Change in Sexual Encounter Profile Question 3 (SEP3) score
Time frame: baseline and 16-week follow up visit
Number of patients with treatment related adverse events
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
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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.
Dimitrios Hatzichristou, Prof. principal investigator
Institute for the Study of Urological Diseases, Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dornier Aries2 LiST Device + 5mg Tadalafil (1) and Dornier Aries2 LiST Device + 5mg Tadalafil (2) in people with Erectile Dysfunction, run by Institute for the Study of Urological Diseases, Greece at 1 site in Greece.
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 19 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: status not confirmed, as of the sponsor's last update on 5 May 2022. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paraskevi Kapoteli (2310963105 ext. +30, pkapotel@auth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between the groups in the change of the Erectile Function (EF) domain score of the International Index of Erectile (IIEF) (time frame: baseline and 12 week follow up visit). 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 5 May 2022.