Erectile Dysfunction
Conditions
Keywords
erectil dysfunction, sildenafil, xybilun
Brief summary
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.
Detailed description
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)
Interventions
DRUGXybilun
Erectil dysfunction, Viagra generic (sildénafil)
Sponsors
Laboratoires Genévrier
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> or equal 18 years * Erectile dysfunction at V1 light (group 1), moderate (group 2), severe (group 3): IIEF-6 score between 6 and 25 (IIEF-6 questions 1-5 and question 15) * More than 3 sexual intercourse * First prescription of Xybilun (gr 1,2,3) or subtitution (gr 4) * Information and non-opposition
Exclusion criteria
* Sildénafil hypersensitivity * Treatment with nitrogen oxide or guanylate cyclase * Patient with sexual intercourse prohibited * NOIANA * Alpha-blocker during past 3 months * Norvir * Participation in an other clinical trial * Patient unable to read properly an information sheet * Patient under guardianship/curatorship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients who has never been treated for ED (group 1,2,3) : responder patients rate at V3 (IIEF-6 : international index of erectil function) | 3 months | 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; |
| 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) | 3 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 month and 3 months | 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) |
| Patients who has never been treated for ED (group 1,2,3) : convenience at V2 month 1 and V3 month 3 (Likert scale) | 1 month and 3 months | 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) |
| Patients who has never been treated for ED (group 1,2,3) : Partner satisfaction (Likert scale) at month 3 | 3 months | 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) |
| Patients with treatment substitution (group 4): International index of erectile function (IIEF) evolution (IIEF15) | 1 month and 3 months | 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) |
| Patients with treatment substitution (group 4): satisfaction (patient/investigator) of previous treatment evaluated at V1 (Day 0) (Likert scale) | Day 0 | 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) |
| Patients with treatment substitution (group 4): satisfaction of Xybilun (patient/investigator) at V2 month 1 and V3 month 3 (Likert scale) | 1 month and 3 months | 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) |
| Patients who has never been treated for ED (group 1,2,3) : responder patients at V2 Month 1 (IIEF-6) | 1 month | 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; |
| Patients with treatment substitution (group 4): convenience Xybilun (patient) at V2 month 1 and V3 month 3 (Likert scale) | 1 month and 3 months | 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) |
| Patients with treatment substitution (group 4): Partner satisfaction at V3 month 3 (Likert scale) | 3 months | 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) |
| Patients with treatment substitution (group 4): reasons of treatment substitution | Day 0 | 1 question : reason of substitution : lack of efficacy, adverse event, bad taste, difficulty of taking, price elevated, ED healing, other (precise) |
| Patients with treatment substitution (group 4): efficacy of Xybilun comparing score IIEF-6 before/after treatment | 1 month and 3 months | 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; |
| safety | 1 month and 3 months | Adverse event : description of AE : open field, related or not to Xybilun, gravity scale (mild, moderate, severe, healththreatening) |
| Patients with treatment substitution (group 4): convenience previous treatment at V1 (day 0) (Likert scale) | Day 0 | 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) |
| Patients who has never been treated for ED (group 1,2,3) : overall satisfaction at 1 month and 3 month | 1 month and 3 months | GAQ Global Assessment Questionnaire : 1 question does the treatment has ameliorate your erection Y/N |
Countries
France
Outcome results
None listed