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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00486-41 | Other Identifier | RCB number |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIESWT arm | Experimental | 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. |
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| Sham arm | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-inclusion questionnaires | Other | (Month -2) During this visit, the investigator will:
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| Measure | Description | Time Frame |
|---|---|---|
| Change in IIEF-EF score | Month 0 versus Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| % 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) | Month 0 versus Month 4 |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria: The patient has contraindications for Cialis as mentioned in the SPC, re-given here :
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| Name | Affiliation | Role |
|---|---|---|
| Stéphane Droupy, MD, PhD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeax - Hôpital Pellegrin | Bordeaux | 33000 | France | |||
| APHP - Hôpital Raymond-Poincaré |
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| 1 month of PDE5i treatment | Drug | 5 mg Tadalafil per day for 1 month |
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| PDE5i follow-up questionnaires | Other | (Month -1) During this visit the investigator will:
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| Inclusion questionnaires | Other | (Day 0) During this visit the investigator will:
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| 4 weekly LIESWT (Wave 1) with the RENOVA device | Device | 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. |
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| 4 weekly sham LIESWT (Wave 1) with the RENOVA device | Device | 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. |
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| Follow-up questionnaires 1 month after Wave 1 | Other | (Month 2) During this visit the investigator will:
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| Follow-up questionnaires 3 months after Wave 1 | Other | (Month 4) During this visit the investigator will:
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| 8 bi-weekly LIESWT (Wave 2) with the RENOVA device | Device | 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. |
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| Follow-up questionnaires 1 month after Wave 2 | Other | (Month 6) During this visit the investigator will:
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| Questionnaires via postal mail | Other | 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. |
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| Final follow-up questionnaires 12 months after Wave 2 | Other | (Month 17) During this visit the investigator will:
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| % 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) | Month -2 versus Month -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) | Month 0 versus Month 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) | Month 0 versus Month 8 |
| % 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) | Month 4 versus Month 8 |
| Change in IIEF-EF score | Change between month -2 and month -1 |
| Change in IIEF-EF score from baseline | Change between month 0 and month 2 |
| Change in IIEF-EF score from baseline | Change between month 0 and month 8 |
| Change in IIEF-EF score from baseline | Change between month 4 and month 8 |
| % patients answering "yes" to the SEP2 | Month 0 versus month 4 |
| % patients answering "yes" to the SEP2 | Month -2 versus month -1 |
| % patients answering "yes" to the SEP2 | Month 0 versus month 2 |
| % patients answering "yes" to the SEP2 | Month 0 versus month 8 |
| % patients answering "yes" to the SEP2 | Month 0 versus month 6 |
| % patients answering "yes" to the SEP2 | Month 0 versus month 11 |
| % patients answering "yes" to the SEP2 | Month 0 versus month 14 |
| % patients answering "yes" to the SEP2 | Month 0 versus month 17 |
| % patients answering "yes" to the SEP3 | Month 0 versus month 4 |
| % patients answering "yes" to the SEP3 | Month -2 versus month -1 |
| % patients answering "yes" to the SEP3 | Month 0 versus month 2 |
| % patients answering "yes" to the SEP3 | Month 0 versus month 8 |
| % patients answering "yes" to the SEP3 | Month 0 versus month 6 |
| % patients answering "yes" to the SEP3 | Month 0 versus month 11 |
| % patients answering "yes" to the SEP3 | Month 0 versus month 14 |
| % patients answering "yes" to the SEP3 | Month 0 versus month 17 |
| % patients answering "yes" to the GAQ | Month 0 versus month 4 |
| % patients answering "yes" to the GAQ | Month -2 versus month -1 |
| % patients answering "yes" to the GAQ | Month 0 versus month 2 |
| % patients answering "yes" to the GAQ | Month 0 versus month 8 |
| % patients answering "yes" to the GAQ | Month 0 versus month 6 |
| % patients answering "yes" to the GAQ | Month 0 versus month 11 |
| % patients answering "yes" to the GAQ | Month 0 versus month 14 |
| % patients answering "yes" to the GAQ | Month 0 versus month 17 |
| Change in EHS | Month 0 versus month 4 |
| Change in EHS | Month -2 versus month -1 |
| Change in EHS | Month 0 versus month 2 |
| Change in EHS | Month 0 versus month 8 |
| Change in EHS | Month 0 versus month 6 |
| Change in EHS | Month 0 versus month 11 |
| Change in EHS | Month 0 versus month 14 |
| Change in EHS | Month 0 versus month 17 |
| Change in IIEF score (including subscores) | Month 0 versus month 4 |
| Change in IIEF score (including subscores) | Month -2 versus month -1 |
| Change in IIEF score (including subscores) | Month 0 versus month 2 |
| Change in IIEF score (including subscores) | Month 0 versus month 8 |
| Change in IIEF score (including subscores) | Month 0 versus month 6 |
| Change in IIEF score (including subscores) | Month 0 versus month 11 |
| Change in IIEF score (including subscores) | Month 0 versus month 14 |
| Change in IIEF score (including subscores) | Month 0 versus month 17 |
| Visual analog scale for pain during treatment | Immediately after treatment session. | Week 1 |
| Visual analog scale for pain during treatment | Immediately after treatment session. | Week 2 |
| Visual analog scale for pain during treatment | Immediately after treatment session. | Week 3 |
| Visual analog scale for pain during treatment | Immediately after treatment session. | Week 4 |
| Visual analog scale for pain during treatment | Immediately after treatment session. | Month 5, week 1 |
| Visual analog scale for pain during treatment | Immediately after treatment session. | Month 5, week 2 |
| Visual analog scale for pain during treatment | Immediately after treatment session. | Month 5, week 3 |
| Visual analog scale for pain during treatment | Immediately after treatment session. | Month 5, week 4 |
| The number of patients with other complications | Any other complications that might occur throughout the study (very few are listed in the literature). | Month 17 |
| Garches |
| 92380 |
| France |
| Clinique Beau Soleil | Montpellier | 34070 | France |
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| CHU de Lyon - Centre Hospitalier Lyon Sud | Pierre-Bénite | 69310 | France |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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