- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02304679
Low Energy Shockwave Therapy for Improving Erectile Dysfunction (Shock-ED)
The Effectiveness of Low Energy Shockwave Therapy for Improving Erectile Dysfunction in Men: a Double Blind Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
- 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
- Device: 4 weekly sham LIESWT (Wave 1) with the RENOVA device
Detailed Description
The secondary objectives of this study are:
A. 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.
B. 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).
C. 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).
D. To evaluate the effect of a 2nd sequence of 4-8 weekly shock wave treatments 3 months after this second sequence.
E. 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.
F. 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.
H. 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Bordeaux, France, 33000
- CHU de Bordeax - Hôpital Pellegrin
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Garches, France, 92380
- APHP - Hôpital Raymond-Poincaré
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Montpellier, France, 34070
- Clinique Beau Soleil
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Nîmes Cedex 09, France, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
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Pierre Benite, France, 69310
- CHU de Lyon - Centre Hospitalier Lyon Sud
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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)
Exclusion Criteria:
- 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
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LIESWT arm
Patients 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. |
(Month -2) During this visit, the investigator will:
5 mg Tadalafil per day for 1 month
(Month -1) During this visit the investigator will:
(Day 0) During this visit the investigator will:
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.
(Month 2) During this visit the investigator will:
(Month 4) During this visit the investigator will:
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.
(Month 6) During this visit the investigator will:
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.
(Month 17) During this visit the investigator will:
|
Placebo Comparator: Sham arm
Patients 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. |
(Month -2) During this visit, the investigator will:
5 mg Tadalafil per day for 1 month
(Month -1) During this visit the investigator will:
(Day 0) During this visit the investigator will:
(Month 2) During this visit the investigator will:
(Month 4) During this visit the investigator will:
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.
(Month 6) During this visit the investigator will:
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.
(Month 17) During this visit the investigator will:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in IIEF-EF score
Time Frame: Month 0 versus Month 4
|
Month 0 versus Month 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% patients with improvement
Time Frame: Month 0 versus Month 4
|
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)
|
Month 0 versus Month 4
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% patients with improvement
Time Frame: Month -2 versus Month -1
|
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)
|
Month -2 versus Month -1
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% patients with improvement
Time Frame: Month 0 versus Month 2
|
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)
|
Month 0 versus Month 2
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% patients with improvement
Time Frame: Month 0 versus Month 8
|
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)
|
Month 0 versus Month 8
|
% patients with improvement
Time Frame: Month 4 versus Month 8
|
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)
|
Month 4 versus Month 8
|
Change in IIEF-EF score
Time Frame: Change between month -2 and month -1
|
Change between month -2 and month -1
|
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Change in IIEF-EF score from baseline
Time Frame: Change between month 0 and month 2
|
Change between month 0 and month 2
|
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Change in IIEF-EF score from baseline
Time Frame: Change between month 0 and month 8
|
Change between month 0 and month 8
|
|
Change in IIEF-EF score from baseline
Time Frame: Change between month 4 and month 8
|
Change between month 4 and month 8
|
|
% patients answering "yes" to the SEP2
Time Frame: Month 0 versus month 4
|
Month 0 versus month 4
|
|
% patients answering "yes" to the SEP2
Time Frame: Month -2 versus month -1
|
Month -2 versus month -1
|
|
% patients answering "yes" to the SEP2
Time Frame: Month 0 versus month 2
|
Month 0 versus month 2
|
|
% patients answering "yes" to the SEP2
Time Frame: Month 0 versus month 8
|
Month 0 versus month 8
|
|
% patients answering "yes" to the SEP2
Time Frame: Month 0 versus month 6
|
Month 0 versus month 6
|
|
% patients answering "yes" to the SEP2
Time Frame: Month 0 versus month 11
|
Month 0 versus month 11
|
|
% patients answering "yes" to the SEP2
Time Frame: Month 0 versus month 14
|
Month 0 versus month 14
|
|
% patients answering "yes" to the SEP2
Time Frame: Month 0 versus month 17
|
Month 0 versus month 17
|
|
% patients answering "yes" to the SEP3
Time Frame: Month 0 versus month 4
|
Month 0 versus month 4
|
|
% patients answering "yes" to the SEP3
Time Frame: Month -2 versus month -1
|
Month -2 versus month -1
|
|
% patients answering "yes" to the SEP3
Time Frame: Month 0 versus month 2
|
Month 0 versus month 2
|
|
% patients answering "yes" to the SEP3
Time Frame: Month 0 versus month 8
|
Month 0 versus month 8
|
|
% patients answering "yes" to the SEP3
Time Frame: Month 0 versus month 6
|
Month 0 versus month 6
|
|
% patients answering "yes" to the SEP3
Time Frame: Month 0 versus month 11
|
Month 0 versus month 11
|
|
% patients answering "yes" to the SEP3
Time Frame: Month 0 versus month 14
|
Month 0 versus month 14
|
|
% patients answering "yes" to the SEP3
Time Frame: Month 0 versus month 17
|
Month 0 versus month 17
|
|
% patients answering "yes" to the GAQ
Time Frame: Month 0 versus month 4
|
Month 0 versus month 4
|
|
% patients answering "yes" to the GAQ
Time Frame: Month -2 versus month -1
|
Month -2 versus month -1
|
|
% patients answering "yes" to the GAQ
Time Frame: Month 0 versus month 2
|
Month 0 versus month 2
|
|
% patients answering "yes" to the GAQ
Time Frame: Month 0 versus month 8
|
Month 0 versus month 8
|
|
% patients answering "yes" to the GAQ
Time Frame: Month 0 versus month 6
|
Month 0 versus month 6
|
|
% patients answering "yes" to the GAQ
Time Frame: Month 0 versus month 11
|
Month 0 versus month 11
|
|
% patients answering "yes" to the GAQ
Time Frame: Month 0 versus month 14
|
Month 0 versus month 14
|
|
% patients answering "yes" to the GAQ
Time Frame: Month 0 versus month 17
|
Month 0 versus month 17
|
|
Change in EHS
Time Frame: Month 0 versus month 4
|
Month 0 versus month 4
|
|
Change in EHS
Time Frame: Month -2 versus month -1
|
Month -2 versus month -1
|
|
Change in EHS
Time Frame: Month 0 versus month 2
|
Month 0 versus month 2
|
|
Change in EHS
Time Frame: Month 0 versus month 8
|
Month 0 versus month 8
|
|
Change in EHS
Time Frame: Month 0 versus month 6
|
Month 0 versus month 6
|
|
Change in EHS
Time Frame: Month 0 versus month 11
|
Month 0 versus month 11
|
|
Change in EHS
Time Frame: Month 0 versus month 14
|
Month 0 versus month 14
|
|
Change in EHS
Time Frame: Month 0 versus month 17
|
Month 0 versus month 17
|
|
Change in IIEF score (including subscores)
Time Frame: Month 0 versus month 4
|
Month 0 versus month 4
|
|
Change in IIEF score (including subscores)
Time Frame: Month -2 versus month -1
|
Month -2 versus month -1
|
|
Change in IIEF score (including subscores)
Time Frame: Month 0 versus month 2
|
Month 0 versus month 2
|
|
Change in IIEF score (including subscores)
Time Frame: Month 0 versus month 8
|
Month 0 versus month 8
|
|
Change in IIEF score (including subscores)
Time Frame: Month 0 versus month 6
|
Month 0 versus month 6
|
|
Change in IIEF score (including subscores)
Time Frame: Month 0 versus month 11
|
Month 0 versus month 11
|
|
Change in IIEF score (including subscores)
Time Frame: Month 0 versus month 14
|
Month 0 versus month 14
|
|
Change in IIEF score (including subscores)
Time Frame: Month 0 versus month 17
|
Month 0 versus month 17
|
|
Visual analog scale for pain during treatment
Time Frame: Week 1
|
Immediately after treatment session.
|
Week 1
|
Visual analog scale for pain during treatment
Time Frame: Week 2
|
Immediately after treatment session.
|
Week 2
|
Visual analog scale for pain during treatment
Time Frame: Week 3
|
Immediately after treatment session.
|
Week 3
|
Visual analog scale for pain during treatment
Time Frame: Week 4
|
Immediately after treatment session.
|
Week 4
|
Visual analog scale for pain during treatment
Time Frame: Month 5, week 1
|
Immediately after treatment session.
|
Month 5, week 1
|
Visual analog scale for pain during treatment
Time Frame: Month 5, week 2
|
Immediately after treatment session.
|
Month 5, week 2
|
Visual analog scale for pain during treatment
Time Frame: Month 5, week 3
|
Immediately after treatment session.
|
Month 5, week 3
|
Visual analog scale for pain during treatment
Time Frame: Month 5, week 4
|
Immediately after treatment session.
|
Month 5, week 4
|
The number of patients with other complications
Time Frame: Month 17
|
Any other complications that might occur throughout the study (very few are listed in the literature).
|
Month 17
|
Collaborators and Investigators
Investigators
- Study Director: Stéphane Droupy, MD, PhD, Centre Hospitalier Universitaire de Nīmes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRC-N/2013/SD-01
- 2014-A00486-41 (Other Identifier: RCB number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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