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Erectile DysfunctionShock-EDNCT02304679

Low Energy Shockwave Therapy for Improving Erectile Dysfunction

A study testing Pre-inclusion questionnaires, 1 month of PDE5i treatment and PDE5i follow-up questionnaires in people with Erectile Dysfunction, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to evaluate the change from baseline in the erectile function domain of the International Index of Erectile Function (IIEF-EF) scores in patients receiving 4 weekly treatments of shockwave therapy versus those receiving a sham treatment. Read more about this study

Who is it for?
Ages 18 to 79 years, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
Pre-inclusion questionnaires, 1 month of PDE5i treatment and PDE5i follow-up questionnaires
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
154 participants
Where
5 sitesFrance
Study dates
1 Jul 2015to 22 Jun 2020
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 18 to 79 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has been correctly informed about the study.
  • The patient must have given his informed and signed consent.
  • The patient must be insured or beneficiary of a health insurance plan.
  • The patient is a man between 18 and 80 years of age. (≥18 years and < 80 years)
  • The patient has been in a stable sexual relationship for over 3 months
  • The patient is consulting for erectile dysfunction lasting for over 6 months
Show all 12Show fewer
  • IIEF-EF6 score between 6 and 25
  • Patients have at least a natural tumescence during sexual stimulation (EHS score ≥ 1)
  • Pre-inclusion: Patient is willing to have 4 weeks of PDE5i treatment at the beginning of the trial, and then stop all treatment for an additional month.
  • Pre-inclusion: The patient agrees to try to engage at least 3 sexual intercourses per month during this period
  • Inclusion: Patient has completed 4 weeks of PDE5i treatment, and then stopped all treatment for an additional month.
  • Patient is available for a follow up of 19 months (at time of pre-inclusion and then 17 months at time of inclusion)

Who cannot join

  • The patient is participating in another interventional study
  • Within the past three months, the patient has participated in another interventional study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection
  • The patient is an adult under guardianship
  • The patient refuses to sign the consent
Show all 29Show fewer
  • It is impossible to correctly inform the patient
  • Complete anerection
  • History of pelvic cancer surgery (radical prostatectomy, cystectomy, abdominoperineal resection of the rectum)
  • Untreated testosterone deficiency
  • Neurological disease affecting the central nervous system
  • Untreated psychiatric disease, or psychiatric disease that may compromise study participation
  • Anatomical malformation of the penis considered by the investigator as being able to prevent vaginal penetration
  • Chronic haematological pathology associated with risk of haemorrhage
  • Oral or injectable antiandrogen treatment
  • The patient is taking blood thinners AND/OR has an International Normalized Ratio >3
  • Known allergy to treatments used in the study (e.g. Cialis, gel)
  • Exclusion criteria: The patient has contraindications for Cialis as mentioned in the SPC, re-given here :
  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SPC.
  • In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of CIALIS to patients who are using any form of organic nitrate is contraindicated. (see section 4.5 of the SPC).
  • CIALIS, must not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.
  • The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated:
  • patients with myocardial infarction within the last 90 days,
  • patients with unstable angina or angina occurring during sexual intercourse,
  • patients with New York Heart Association Class 2 or greater heart failure in the last 6 months,
  • patients with uncontrolled arrhythmias, hypotension (< 90/50 mm Hg), or uncontrolled
  • uncontrolled hypertension,
  • patients with a stroke within the last 6 months.
  • CIALIS is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4 of the SPC).

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • CHU de Bordeax - Hôpital Pellegrin

    Bordeaux, 33000

  • APHP - Hôpital Raymond-Poincaré

    Garches, 92380

  • Clinique Beau Soleil

    Montpellier, 34070

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

  • CHU de Lyon - Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

Other trials in France

About this study

Official title: The Effectiveness of Low Energy Shockwave Therapy for Improving Erectile Dysfunction in Men: a Double Blind Randomized Controlled Trial

The primary objective of this study is to evaluate the change from baseline in the erectile function domain of the International Index of Erectile Function (IIEF-EF) scores in patients receiving 4 weekly treatments of shockwave therapy versus those receiving a sham treatment. The change will be evaluated at 3 months after the end of a sequence of 4 weekly treatments.

Read the detailed description

The secondary objectives of this study are:

  1. To evaluate erectile function (EF) categorical improvement in patients receiving 4 weekly treatments of shockwave therapy versus those receiving a sham treatment, at 3 months after a first sequence of treatment.
  2. To compare improvements in erectile function between 4 weeks of phosphodiesterase type 5 inhibitor (PDE5i) use and 4 weekly treatments of shockwave therapy ("within patient" effect).
  3. To compare improvements in erectile function between 4 weeks of PDE5 inhibitor use and 4 weekly treatments of sham shock wave therapy ("within patient" effect).
  4. To evaluate the effect of a 2nd sequence of 4-8 weekly shock wave treatments 3 months after this second sequence.
  5. To evaluate treatment effects (the same comparisons as in objectives A, B, C, D) on other validated measure of EF (question 2 of the sexual encounter profile (SEP2), question 3 of the sexual encounter profile (SEP3), Global Assessment Question (GAQ), Erection Hardness Scale (EHS)), and the remaining domains of the IIEF score (orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction), as well as the total IIEF score.
  6. To evaluate treatment tolerance and potential adverse events. G. To compare changes in EF measures over time for a follow-up period of 12 months following the second sequence of 4 weekly shock wave treatments.
  7. To compare the effect of a sequence of 4 weekly shock wave treatments versus 8 biweekly shock wave treatments 3 months after the treatment ("within patient" effect).
Being tested
Pre-inclusion questionnaires, 1 month of PDE5i treatment, PDE5i follow-up questionnaires, Inclusion questionnaires, 4 weekly LIESWT (Wave 1) with the RENOVA device
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pre-inclusion questionnairesOther

    (Month -2)

    During this visit, the investigator will:

    • Validate the patient's inclusion and exclusion criteria;
    • Obtain informed consent from the patient;
    • Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope in order to respect patient confidentiality.
    • Prescribe 1 month of PDE5i treatment.
    • The next visit will be scheduled

  • 1 month of PDE5i treatmentDrug

    5 mg Tadalafil per day for 1 month

  • PDE5i follow-up questionnairesOther

    (Month -1)

    During this visit the investigator will:

    • Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope in order to respect patient confidentiality.
    • Perform a clinical exam; particular attention is given to the recording of complications / adverse events.
    • Remind the patient that over the next 4 weeks he is not to take any treatments for his condition (wash-out period).
    • The next visit will be scheduled

  • Inclusion questionnairesOther

    (Day 0)

    During this visit the investigator will:

    • Verify inclusion and exclusion criteria, and proceed with final inclusion
    • Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope in order to respect patient confidentiality.
    • Perform a clinical exam; particular attention is given to the recording of complications / adverse events.
    • Randomize the patient at the end of the visit
    • The patient will go home with a calendar specifying the time and place of the various visits. The patient should have four weekly LIESWT or sham sessions within the next month. The first session may take place the same day and immediately after the present visit.

  • 4 weekly LIESWT (Wave 1) with the RENOVA deviceDevice

    Following final inclusion, patients will have weekly LIESWT sessions (one session per week for four weeks). Particular attention is given to the recording of complications/adverse events. At the end of each session, the patient is asked to evaluate the level of pain that occurred during the session using a visual analog scale.

  • 4 weekly sham LIESWT (Wave 1) with the RENOVA deviceDevice

    Following final inclusion, patients will have weekly sham LIESWT sessions (one session per week for four weeks). Particular attention is given to the recording of complications/adverse events. At the end of each session, the patient is asked to evaluate the level of pain that occurred during the session using a visual analog scale.

  • Follow-up questionnaires 1 month after Wave 1Other

    (Month 2)

    During this visit the investigator will:

    • Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope.
    • Perform a clinical exam; particular attention is given to the recording of complications / adverse events.

  • Follow-up questionnaires 3 months after Wave 1Other

    (Month 4)

    During this visit the investigator will:

    • Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope.
    • Perform a clinical exam; particular attention is given to the recording of complications / adverse events.
    • The patient should have four weekly LIESWT sessions within the next month. The first session may take place the same day and immediately after the present visit.

  • 8 bi-weekly LIESWT (Wave 2) with the RENOVA deviceDevice

    During the 5th month following final inclusion, all patients will have bi-weekly LIESWT sessions. These will occur twice per week for four consecutive weeks. Particular attention is given to the recording of complications/adverse events. At the end of each session, the patient is asked to evaluate the level of pain that occurred during the session using a visual analog scale.

  • Follow-up questionnaires 1 month after Wave 2Other

    (Month 6)

    During this visit the investigator will:

    • Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope.
    • Perform a clinical exam; particular attention is given to the recording of complications / adverse events.

  • Questionnaires via postal mailOther

    Eight, 11, and 14 months after final inclusion, corresponding to 3, 6 and 9 months following Wave 2, the IIEF, SEP2, SEP3, GAQ and EHS questionnaires will be sent to patients via postal mail.

  • Final follow-up questionnaires 12 months after Wave 2Other

    (Month 17)

    During this visit the investigator will:

    • Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope.
    • Perform a clinical exam; particular attention is given to the recording of complications / adverse events.
Study groups in NCT02304679
Study groupRoleWhat they receive
LIESWT armExperimentalPatients randomized to this arm will have two sequences of Low-Intensity Extracorporeal Shock Wave Therapy (LIESWT). Interventions: Pre-inclusion questionnaires; 1 month of PDE5i treatment; PDE5i follow-up questionnaires; Inclusion questionnaires; 4 weekly LIESWT (Wave 1) with the RENOVA device; Follow-up questionnaires 1 month after Wave 1; Follow-up questionnaires 3 months after Wave 1; 8 bi-weekly LIESWT (Wave 2) with the RENOVA device; Follow-up questionnaires 1 month after Wave 2; Questionnaires via postal mail; Final follow-up questionnaires 12 months after Wave 2.
Receives: Other: Pre-inclusion questionnaires; Drug: 1 month of PDE5i treatment; Other: PDE5i follow-up questionnaires; Other: Inclusion questionnaires; Device: 4 weekly LIESWT (Wave 1) with the RENOVA device; Other: Follow-up questionnaires 1 month after Wave 1; Other: Follow-up questionnaires 3 months after Wave 1; Device: 8 bi-weekly LIESWT (Wave 2) with the RENOVA device; Other: Follow-up questionnaires 1 month after Wave 2; Other: Questionnaires via postal mail; Other: Final follow-up questionnaires 12 months after Wave 2
Sham armPlacebo comparatorPatients randomized to this arm will have one sequence of sham Low-Intensity Extracorporeal Shock Wave Therapy and then three months later one sequence of Low-Intensity Extracorporeal Shock Wave Therapy. Interventions: Pre-inclusion questionnaires; 1 month of PDE5i treatment; PDE5i follow-up questionnaires; Inclusion questionnaires; 4 weekly sham LIESWT (Wave 1) with the RENOVA device; Follow-up questionnaires 1 month after Wave 1; Follow-up questionnaires 3 months after Wave 1; 8 bi-weekly LIESWT (Wave 2) with the RENOVA device; Follow-up questionnaires 1 month after Wave 2; Questionnaires via postal mail; Final follow-up questionnaires 12 months after Wave 2.
Receives: Other: Pre-inclusion questionnaires; Drug: 1 month of PDE5i treatment; Other: PDE5i follow-up questionnaires; Other: Inclusion questionnaires; Device: 4 weekly sham LIESWT (Wave 1) with the RENOVA device; Other: Follow-up questionnaires 1 month after Wave 1; Other: Follow-up questionnaires 3 months after Wave 1; Device: 8 bi-weekly LIESWT (Wave 2) with the RENOVA device; Other: Follow-up questionnaires 1 month after Wave 2; Other: Questionnaires via postal mail; Other: Final follow-up questionnaires 12 months after Wave 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in IIEF-EF score

    Measured: Month 0 versus Month 4

Secondary outcomes (58)

  1. % patients with improvement

    The presence/absence of improvement in erectile function as compared to baseline. Improvement in erectile function is defined as a >2 point increase in the IIEF-EF score from baseline for mild erectile dysfunction, >5 points for moderate erectile dysfunction and >7 points for severe erectile dysfunction(Rosen et al. 2011)

    Measured: Month 0 versus Month 4

  2. % patients with improvement

    The presence/absence of improvement in erectile function as compared to baseline. Improvement in erectile function is defined as a >2 point increase in the IIEF-EF score from baseline for mild erectile dysfunction, >5 points for moderate erectile dysfunction and >7 points for severe erectile dysfunction(Rosen et al. 2011)

    Measured: Month -2 versus Month -1

  3. % patients with improvement

    The presence/absence of improvement in erectile function as compared to baseline. Improvement in erectile function is defined as a >2 point increase in the IIEF-EF score from baseline for mild erectile dysfunction, >5 points for moderate erectile dysfunction and >7 points for severe erectile dysfunction(Rosen et al. 2011)

    Measured: Month 0 versus Month 2

  4. % patients with improvement

    The presence/absence of improvement in erectile function as compared to baseline. Improvement in erectile function is defined as a >2 point increase in the IIEF-EF score from baseline for mild erectile dysfunction, >5 points for moderate erectile dysfunction and >7 points for severe erectile dysfunction(Rosen et al. 2011)

    Measured: Month 0 versus Month 8

  5. % patients with improvement

    The presence/absence of improvement in erectile function as compared to baseline. Improvement in erectile function is defined as a >2 point increase in the IIEF-EF score from baseline for mild erectile dysfunction, >5 points for moderate erectile dysfunction and >7 points for severe erectile dysfunction(Rosen et al. 2011)

    Measured: Month 4 versus Month 8

  6. Change in IIEF-EF score

    Measured: Change between month -2 and month -1

  7. Change in IIEF-EF score from baseline

    Measured: Change between month 0 and month 2

  8. Change in IIEF-EF score from baseline

    Measured: Change between month 0 and month 8

  9. Change in IIEF-EF score from baseline

    Measured: Change between month 4 and month 8

  10. % patients answering "yes" to the SEP2

    Measured: Month 0 versus month 4

  11. % patients answering "yes" to the SEP2

    Measured: Month -2 versus month -1

  12. % patients answering "yes" to the SEP2

    Measured: Month 0 versus month 2

  13. % patients answering "yes" to the SEP2

    Measured: Month 0 versus month 8

  14. % patients answering "yes" to the SEP2

    Measured: Month 0 versus month 6

  15. % patients answering "yes" to the SEP2

    Measured: Month 0 versus month 11

  16. % patients answering "yes" to the SEP2

    Measured: Month 0 versus month 14

  17. % patients answering "yes" to the SEP2

    Measured: Month 0 versus month 17

  18. % patients answering "yes" to the SEP3

    Measured: Month 0 versus month 4

  19. % patients answering "yes" to the SEP3

    Measured: Month -2 versus month -1

  20. % patients answering "yes" to the SEP3

    Measured: Month 0 versus month 2

  21. % patients answering "yes" to the SEP3

    Measured: Month 0 versus month 8

  22. % patients answering "yes" to the SEP3

    Measured: Month 0 versus month 6

  23. % patients answering "yes" to the SEP3

    Measured: Month 0 versus month 11

  24. % patients answering "yes" to the SEP3

    Measured: Month 0 versus month 14

  25. % patients answering "yes" to the SEP3

    Measured: Month 0 versus month 17

  26. % patients answering "yes" to the GAQ

    Measured: Month 0 versus month 4

  27. % patients answering "yes" to the GAQ

    Measured: Month -2 versus month -1

  28. % patients answering "yes" to the GAQ

    Measured: Month 0 versus month 2

  29. % patients answering "yes" to the GAQ

    Measured: Month 0 versus month 8

  30. % patients answering "yes" to the GAQ

    Measured: Month 0 versus month 6

  31. % patients answering "yes" to the GAQ

    Measured: Month 0 versus month 11

  32. % patients answering "yes" to the GAQ

    Measured: Month 0 versus month 14

  33. % patients answering "yes" to the GAQ

    Measured: Month 0 versus month 17

  34. Change in EHS

    Measured: Month 0 versus month 4

  35. Change in EHS

    Measured: Month -2 versus month -1

  36. Change in EHS

    Measured: Month 0 versus month 2

  37. Change in EHS

    Measured: Month 0 versus month 8

  38. Change in EHS

    Measured: Month 0 versus month 6

  39. Change in EHS

    Measured: Month 0 versus month 11

  40. Change in EHS

    Measured: Month 0 versus month 14

  41. Change in EHS

    Measured: Month 0 versus month 17

  42. Change in IIEF score (including subscores)

    Measured: Month 0 versus month 4

  43. Change in IIEF score (including subscores)

    Measured: Month -2 versus month -1

  44. Change in IIEF score (including subscores)

    Measured: Month 0 versus month 2

  45. Change in IIEF score (including subscores)

    Measured: Month 0 versus month 8

  46. Change in IIEF score (including subscores)

    Measured: Month 0 versus month 6

  47. Change in IIEF score (including subscores)

    Measured: Month 0 versus month 11

  48. Change in IIEF score (including subscores)

    Measured: Month 0 versus month 14

  49. Change in IIEF score (including subscores)

    Measured: Month 0 versus month 17

  50. Visual analog scale for pain during treatment

    Immediately after treatment session.

    Measured: Week 1

  51. Visual analog scale for pain during treatment

    Immediately after treatment session.

    Measured: Week 2

  52. Visual analog scale for pain during treatment

    Immediately after treatment session.

    Measured: Week 3

  53. Visual analog scale for pain during treatment

    Immediately after treatment session.

    Measured: Week 4

  54. Visual analog scale for pain during treatment

    Immediately after treatment session.

    Measured: Month 5, week 1

  55. Visual analog scale for pain during treatment

    Immediately after treatment session.

    Measured: Month 5, week 2

  56. Visual analog scale for pain during treatment

    Immediately after treatment session.

    Measured: Month 5, week 3

  57. Visual analog scale for pain during treatment

    Immediately after treatment session.

    Measured: Month 5, week 4

  58. The number of patients with other complications

    Any other complications that might occur throughout the study (very few are listed in the literature).

    Measured: Month 17

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2014 (estimated)
  2. Study start1 Jul 2015
  3. Primary completion21 Feb 2018
  4. Study completion22 Jun 2020

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02304679
Sponsor's protocol ID
PHRC-N/2013/SD-01
Other IDs
2014-A00486-41
Acronym
Shock-ED
Status last verified
Aug 2020
First submitted
20 Nov 2014
Last updated
4 Aug 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Pre-inclusion questionnaires, 1 month of PDE5i treatment and PDE5i follow-up questionnaires in people with Erectile Dysfunction, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.

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 12 inclusion and 29 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 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. 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?

Change in IIEF-EF score (time frame: Month 0 versus Month 4). 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 NCT02304679.

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 4 Aug 2020.

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