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Erectile DysfunctionProstaChoc 1NCT02746094

Low Frequency Shock Wave Therapy for Improving Post-prostatectomy Erectile Dysfunction: a Prospective Pilot Study

A study testing 8 bi-weekly LIESWT sessions in people with Erectile Dysfunction, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The primary objective of this study is to evaluate changes in erectile function (EF) before versus after 8 bi-weekly treatments of Low-Intensity Extracorporeal Shock Wave Therapy (LIESWT) via IIEF-EF (the Erectile Function domain of the International Index of Erectile Function) scores. 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?
8 bi-weekly LIESWT sessions
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteFrance
Study dates
Apr 2017to Apr 2019
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 given his informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is a man at least 18 years old and less than 80 years old
  • The patient has been in a stable, sexual relationship with only one other person for at least the past three months
  • The patient is consulting for erectile dysfunction lasting for over 6 months
  • The patient had a prostatectomy 18 to 60 months ago
Show all 10Show fewer
  • The patient has an erectile function domain score on the International Index of Erectile Function questionnaire between 6 and 25
  • The patient has at least a natural tumescence during sexual stimulation (erection hardness score ≥ 1)
  • The patient has not had phosphodiesterase type 5 inhibitor treatment for the month preceding inclusion
  • The patient is available for 8 months of follow-up and agrees to participate in all study visits

Who cannot join

  • The patient is participating in another interventional study, or has participated in another interventional study within the past 3 months
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, or is an adult under guardianship
  • It is impossible to correctly inform the patient, or the patient refuses to sign the consent
  • Complete anerection
  • Untreated testosterone deficiency
Show all 13Show fewer
  • Neurological disease
  • Psychiatric disease
  • Anatomical malformation of the penis
  • Chronic haematological pathology with significant clinical impact
  • Oral or injectable antiandrogen treatment
  • The patient is taking blood thinners and has an international normalized ratio > 3
  • History of erectile dysfunction before the prostatectomy

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

The primary objective of this study is to evaluate changes in erectile function (EF) before versus after 8 bi-weekly treatments of Low-Intensity Extracorporeal Shock Wave Therapy (LIESWT) via IIEF-EF (the Erectile Function domain of the International Index of Erectile Function) scores.

Read the detailed description

The secondary objectives of this study are to evaluate changes in the following elements before versus after 8 bi-weekly treatments of LIESWT:

  1. EF categorical improvement.
  2. Other validated measures of EF (SEP2 (question 2 of the sexual encounter profile), SEP3 (question 3 of the sexual encounter profile), GAQ (Global Assessment Question), EHS (Erection Hardness Score)), and the remaining domains of the IIEF score (orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction), as well as the total IIEF score.
  3. Harms/Safety: To evaluate treatment tolerance and potential adverse events.
Being tested
8 bi-weekly LIESWT sessions
Medical subject headings
Erectile Dysfunction

What participants receive

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

  • 8 bi-weekly LIESWT sessionsDevice

    Also called RENOVA device

    LIESWT = Low-Intensity Extracorporeal Shock Wave Therapy

    The treatment protocol consists of eight bi-weekly treatment sessions (weeks 0 ot 4). During each session 3600 shocks at 0.09 mJ/mm are applied. Shocks are applied to the penis shaft at the right corpus cavernosum and the left corpus cavernosum, and at the crura at the right crus and the left crus. 900 shocks are administered to each area. The treatment areas are the same for each session, so that at the end of the full treatment (8 sessions) each area will have received 7200 shocks at 0.09 mJ/mm.

    In general, the patient is placed on an examination table. A series of focused shockwaves produced by the electromagnetic transducer are coupled to a patient's penile shaft and crura and are made to converge along the penis/crura volume. The operator controls treatment parameters including shockwave intensity and shockwave rate.

    mJ = millijoule.

Study groups in NCT02746094
Study groupRoleWhat they receive
The study populationExperimentalThe study population is comprised of adult men less than 80 years of age who are consulting for ED lasting for over 6 months following a prostatectomy that took place 18 to 60 months ago. The patients are currently in a stable relationship that has been going on for at least 3 months, have an IIEF-EF score between 6 and 25, and have at least a natural tumescence during sexual stimulation (EHS score ≥ 1). Intervention: 8 bi-weekly LIESWT sessions
Receives: Device: 8 bi-weekly LIESWT sessions

What is being measured

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

  1. The difference in the rate of change for the IIEF-EF score before and after treatment sessions (change per two-month period).

    IIEF-EF = the erectile function domain of the International Index of Erectile Function

    Measured: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks

Secondary outcomes (35)

  1. The change in the number of patients with improvement in erectile function (EF) over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.

    Improvement in EF is defined as a >2 point increase in the IIEF-EF score from baseline for mild erectile dysfunction (ED), >5 points for moderate ED and >7 points for severe ED (Rosen et al. 2011).

    Measured: -8 to 0 weeks versus 0 to 8 weeks

  2. The change in the number of patients with improvement in erectile function (EF) over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.

    Improvement in EF is defined as a >2 point increase in the IIEF-EF score from baseline for mild erectile dysfunction (ED), >5 points for moderate ED and >7 points for severe ED (Rosen et al. 2011).

    Measured: -8 to 0 weeks versus 0 to 16 weeks

  3. The change in the number of patients with improvement in erectile function (EF) over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.

    Improvement in EF is defined as a >2 point increase in the IIEF-EF score from baseline for mild erectile dysfunction (ED), >5 points for moderate ED and >7 points for severe ED (Rosen et al. 2011).

    Measured: 0 to 8 weeks versus 8 to 16 weeks

  4. The change in the number of patients responding yes to question 2 of the Sexual Encounter Profile over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.

    Were you able to insert your penis into your partner's vagina? (yes/no)

    Measured: -8 to 0 weeks versus 0 to 8 weeks

  5. The change in the number of patients responding yes to question 2 of the Sexual Encounter Profile over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.

    Were you able to insert your penis into your partner's vagina? (yes/no)

    Measured: -8 to 0 weeks versus 0 to 16 weeks

  6. The change in the number of patients responding yes to question 2 of the Sexual Encounter Profile over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.

    Were you able to insert your penis into your partner's vagina? (yes/no)

    Measured: 0 to 8 weeks versus 8 to 16 weeks

  7. The change in the number of patients responding yes to question 3 of the Sexual Encounter Profile over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.

    Did your erection last long enough for you to have successful intercourse? (yes/no)

    Measured: -8 to 0 weeks versus 0 to 8 weeks

  8. The change in the number of patients responding yes to question 3 of the Sexual Encounter Profile over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.

    Did your erection last long enough for you to have successful intercourse? (yes/no)

    Measured: -8 to 0 weeks versus 0 to 16 weeks

  9. The change in the number of patients responding yes to question 3 of the Sexual Encounter Profile over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.

    Did your erection last long enough for you to have successful intercourse? (yes/no)

    Measured: 0 to 8 weeks versus 8 to 16 weeks

  10. The change in the number of patients responding yes to the Global Assessment Question (yes/no) over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.

    Has the treatment you have been taking improved your erectile function? (yes/no)

    Measured: -8 to 0 weeks versus 0 to 8 weeks

  11. The change in the number of patients responding yes to the Global Assessment Question (yes/no) over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.

    Has the treatment you have been taking improved your erectile function? (yes/no)

    Measured: -8 to 0 weeks versus 0 to 16 weeks

  12. The change in the number of patients responding yes to the Global Assessment Question (yes/no) over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.

    Has the treatment you have been taking improved your erectile function? (yes/no)

    Measured: 0 to 8 weeks versus 8 to 16 weeks

  13. The difference in the rate of change for the total IIEF score before and after treatment sessions (change per two-month period)

    Measured: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks

  14. The difference in the rate of change for the total IIEF score before and after treatment sessions (change per two-month period)

    Measured: rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks

  15. The difference in the rate of change for the IIEF erectile function subdomain score before and after treatment sessions (change per two-month period)

    Measured: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks

  16. The difference in the rate of change for the IIEF erectile function subdomain score before and after treatment sessions (change per two-month period)

    Measured: rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks

  17. The difference in the rate of change for the IIEF sexual satisfaction subdomain score before and after treatment sessions (change per two-month period)

    Measured: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks

  18. The difference in the rate of change for the IIEF sexual satisfaction subdomain score before and after treatment sessions (change per two-month period)

    Measured: rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks

  19. The difference in the rate of change for the IIEF orgasmic function subdomain score before and after treatment sessions (change per two-month period)

    Measured: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks

  20. The difference in the rate of change for the IIEF orgasmic function subdomain score before and after treatment sessions (change per two-month period)

    Measured: rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks

  21. The difference in the rate of change for the IIEF sexual desire subdomain score before and after treatment sessions (change per two-month period)

    Measured: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks

  22. The difference in the rate of change for the IIEF sexual desire subdomain score before and after treatment sessions (change per two-month period)

    Measured: rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks

  23. The difference in the rate of change for the IIEF overall satisfaction subdomain score before and after treatment sessions (change per two-month period)

    Measured: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks

  24. The difference in the rate of change for the IIEF overall satisfaction subdomain score before and after treatment sessions (change per two-month period)

    Measured: rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks

  25. The difference in the rate of change for the EHS Score before and after treatment sessions (change per two-month period)

    Measured: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks

  26. The difference in the rate of change for the EHS Score before and after treatment sessions (change per two-month period)

    Measured: rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks

  27. Visual analog scale for pain during treatment (score from 0 to 10)

    Measured: Week 1, Monday or Tuesday

  28. Visual analog scale for pain during treatment (score from 0 to 10)

    Measured: Week 1, Thursday or Friday

  29. Visual analog scale for pain during treatment (score from 0 to 10)

    Measured: Week 2, Monday or Tuesday

  30. Visual analog scale for pain during treatment (score from 0 to 10)

    Measured: Week 2, Thursday or Friday

  31. Visual analog scale for pain during treatment (score from 0 to 10)

    Measured: Week 3, Monday or Tuesday

  32. Visual analog scale for pain during treatment (score from 0 to 10)

    Measured: Week 3, Thursday or Friday

  33. Visual analog scale for pain during treatment (score from 0 to 10)

    Measured: Week 4, Monday or Tuesday

  34. Visual analog scale for pain during treatment (score from 0 to 10)

    Measured: Week 4, Thursday or Friday

  35. The presence/absence any other complications that might occur (almost none are cited in the literature)

    Measured: Week 16

Timeline

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

  1. First posted21 Apr 2016 (estimated)
  2. Study startApr 2017 (estimated)
  3. Primary completionApr 2019 (estimated)
  4. Study completionApr 2019 (estimated)

Why it stopped: Change strategy

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02746094
Sponsor's protocol ID
LOCAL/2016/SD-01
Acronym
ProstaChoc 1
Status last verified
Jun 2017
First submitted
13 Apr 2016
Last updated
20 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30.

    PubMed 21855209

Questions about this trial

What is this clinical trial studying?

A study testing 8 bi-weekly LIESWT sessions in people with Erectile Dysfunction, run by Centre Hospitalier Universitaire de Nīmes at 1 site 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 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Jun 2017. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference in the rate of change for the IIEF-EF score before and after treatment sessions (change per two-month period). (time frame: rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks). 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 NCT02746094, which also lists 1 linked publication.

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 20 Jun 2017.

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