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Collecting Xybilun (Viagra's generic) efficacity, tolerance, convenience and patients/doctors satisfaction's data at different doses (50-75-100 mg), is the aim of the study.
Study design
Population Patients without prior treatment with a first Xybilun prescription Patients already treated for who the treatment is remplaced by Xybilun
Study perimeter 400 patients 50 investigators (sexologists, urologists)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xybilun: mild erectil dysfunction | Patient who has never been treated for his ED (erectil dysfunction), with mild ED (score IIEF-6 between 22 and 25) and begin treatment at 50 mg |
| |
| Xybilun: moderate erectil dysfunction | Patient who has never been treated for his ED (erectil dysfunction), with moderate ED (score IIEF-6 between 11 and 21) and begin treatment at 50 mg |
| |
| Xybilun: severe erectil dysfunction | Patient who has never been treated for his ED (erectil dysfunction), with severe ED (score between 6 and 10) and begin treatment at 50 mg |
| |
| Xybilun switch | Substitution dose to dose of previous treatment by Xybilun whatever the severity of ED. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xybilun | Drug | Erectil dysfunction, Viagra generic (sildénafil) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients who has never been treated for ED (group 1,2,3) : responder patients rate at V3 (IIEF-6 : international index of erectil function) | Group 1: patient good responder if there is an increase of at least 2 points regarding score of IIEF-6; Group 2: patient good responder if there is an increase of at least 5 points regarding score of IIEF-6; Group 3: patient good responder if there is an increase of at least 7 points regarding score of IIEF-6; | 3 months |
| Patients with treatment substitution (group 4): satisfaction of Xybilun vs previous treatment at V3 (Likert scale 5 points : 1-Not satisfied at all, 2-not very satisfied, 3-nor satisfied nor unsatisfied, 4- satisfied, 5-very satisfied) | Likert scale in 5 point evaluated at V3: "Are you more satisfied regarding you previous treatment then your current treatment?" Patient improved if his answer is "satisfied" (score 4) or "very satisfied" (score 5). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patients who has never been treated for ED (group 1,2,3) : responder patients at V2 Month 1 (IIEF-6) | score IIEF-6 (international index erectif function) score frome 0 to 30 : 22-25 ED mild, 11-21 ED moderate, 6-10 ED severe Group 1: patient good responder if there is an increase of at least 2 points regarding score of IIEF-6; Group 2: patient good responder if there is an increase of at least 5 points regarding score of IIEF-6; Group 3: patient good responder if there is an increase of at least 7 points regarding score of IIEF-6; |
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Inclusion Criteria:
Exclusion Criteria:
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Man suffering from all type of erectil dysfunction (light, moderate, severe).
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| Name | Affiliation | Role |
|---|---|---|
| DROUPY SD Stéphane, Urologist | CHU Nîmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nîmes | Nantes | Haute-Bretagne | 44000 | France |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| 1 month |
| Patients who has never been treated for ED (group 1,2,3) : overall satisfaction at 1 month and 3 month | GAQ Global Assessment Questionnaire : 1 question "does the treatment has ameliorate your erection" Y/N | 1 month and 3 months |
| Patients who has never been treated for ED (group 1,2,3) : Patient Xybilun and investigator satisfaction at V2 month 1 and V3 month 3 | Likert scale (5 points) : 1 question : "are you satisfied of Xybilun?" (Likert scale 5 points : 1-Not satisfied at all, 2-not very satisfied, 3-nor satisfied nor unsatisfied, 4- satisfied, 5-very satisfied) | 1 month and 3 months |
| Patients who has never been treated for ED (group 1,2,3) : convenience at V2 month 1 and V3 month 3 (Likert scale) | Likert scale (5 points) : 1 question "How convenient Xybilun is ?) (Likert scale 5 points : 1-Not convenient at all, 2-not very convenient, 3-nor convenient nor unconvenient, 4- convenient, 5-very convenient) | 1 month and 3 months |
| Patients who has never been treated for ED (group 1,2,3) : Partner satisfaction (Likert scale) at month 3 | Likert scale (5 points): (optional data) 1 question : "are you satisfied of Xybilun?" (Likert scale 5 points : 1-Not satisfied at all, 2-not very satisfied, 3-nor satisfied nor unsatisfied, 4- satisfied, 5-very satisfied) | 3 months |
| Patients with treatment substitution (group 4): International index of erectile function (IIEF) evolution (IIEF15) | IIEF15 international index of erectile function (15 questions scored from 0 to 5) ; score from 0 to 75 to evaluate globale erectil dysfunction (not used for classify the disfunction only to see the score evolution in the time) | 1 month and 3 months |
| Patients with treatment substitution (group 4): satisfaction (patient/investigator) of previous treatment evaluated at V1 (Day 0) (Likert scale) | Likert scale (5 points) : "Are you more satisfied regarding you previous treatment then your current treatment?" scale 5 points : 1-Not satisfied at all, 2-not very satisfied, 3-nor satisfied nor unsatisfied, 4- satisfied, 5-very satisfied) | Day 0 |
| Patients with treatment substitution (group 4): satisfaction of Xybilun (patient/investigator) at V2 month 1 and V3 month 3 (Likert scale) | Likert scale (5 points) : 1 question : "are you satisfied of Xybilun?" (Likert scale 5 points : 1-Not satisfied at all, 2-not very satisfied, 3-nor satisfied nor unsatisfied, 4- satisfied, 5-very satisfied) | 1 month and 3 months |
| Patients with treatment substitution (group 4): convenience previous treatment at V1 (day 0) (Likert scale) | Likert scale (5 points) 1 question "How convenient you previous treatment was ?) (Likert scale 5 points : 1-Not convenient at all, 2-not very convenient, 3-nor convenient nor unconvenient, 4- convenient, 5-very convenient) | Day 0 |
| Patients with treatment substitution (group 4): convenience Xybilun (patient) at V2 month 1 and V3 month 3 (Likert scale) | Likert scale (5 points) 1 question "How convenient Xybilun is ?) (Likert scale 5 points : 1-Not convenient at all, 2-not very convenient, 3-nor convenient nor unconvenient, 4- convenient, 5-very convenient) | 1 month and 3 months |
| Patients with treatment substitution (group 4): Partner satisfaction at V3 month 3 (Likert scale) | ikert scale (5 points): (optional data) 1 question : "are you satisfied of Xybilun?" (Likert scale 5 points : 1-Not satisfied at all, 2-not very satisfied, 3-nor satisfied nor unsatisfied, 4- satisfied, 5-very satisfied) | 3 months |
| Patients with treatment substitution (group 4): reasons of treatment substitution | 1 question : "reason of substitution : lack of efficacy, adverse event, bad taste, difficulty of taking, price elevated, ED healing, other (precise)" | Day 0 |
| Patients with treatment substitution (group 4): efficacy of Xybilun comparing score IIEF-6 before/after treatment | score IIEF-6 (international index erectif function) score frome 0 to 30 : 22-25 ED mild, 11-21 ED moderate, 6-10 ED severe ED mild: responder if there is an increase of at least 2 points regarding score of IIEF-6; ED moderate: responder if there is an increase of at least 5 points regarding score of IIEF-6; ED severe: responder if there is an increase of at least 7 points regarding score of IIEF-6; | 1 month and 3 months |
| safety | Adverse event : description of AE : open field, related or not to Xybilun, gravity scale (mild, moderate, severe, healththreatening) | 1 month and 3 months |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |