Erectile dysfunction Urological and Genital Diseases Erectile dysfunction
Conditions
Interventions
Current interventions as of 25/01/2008:
Trial medication:
1. Viagra® (50 mg oral daily dosing)
2. Caverject Impuls® (2.5 µg - 10 µg three times weekly)
Previous interventions:
Trial medication:
1.
Sponsors
Johannes Gutenberg Universität Mainz (Germany)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent indicating that the patient has been informed of all pertinent aspects of the trial before undergoing screening for the study 2. Ability of patient to understand character and individual consequences of clinical trial 3. Men older than 30 and younger than 65 4. Preoperative normal IIEF domain score more than 60 (total: 75) 5. Preoperative normal IIEF-EF domain score more than 25 (total: 30) 6. No neo-adjuvant therapy for prostate cancer before surgery 7. No use of drugs or devices for Erectile Dysfunction (ED) treatment before surgery (e.g. PDE-5-Inhibitor) 8. Patient in stable heterosexual relationship for at least six months 9. Planned surgery techniques: bilateral nerve sparing radical retropubic prostatatectomy 10. No adjuvant therapy after prostatectomy (i.e. androgen deprivation, radiatio therapy) 11. Documented clinical diagnosis of postoperative erectile dysfunction based on IIEF domain score less than 60 12. Documented clinical diagnosis of postoperative erectile dysfunction based on IIEF-EF domain score less than 25
Exclusion criteria
Exclusion criteria: 1. Hypotension (Blood Pressure [BP] less than 90/50 mmHg) 2. Hypertension (BP more than 170/110 mmHg) 3. Patients with significant cardiovascular diseases in the last six months, including cardiac failure, myocardial infarction, unstable angina, stroke, symptomatic or clinically significant arrhythmias 4. Patients with blood coagulation disorder 5. Patients who are advised against sexual activity for medical reasons (e.g. patients with severe cardiovasucular disorders) 6. Patients who have conditions that might predispose them to priapism, such as sickle cell anaemia or trait, multiole myeloma, or leukaemia 7. Patients with severe liver insufficiency (e.g. cirrhosis, CHILD C) 8. Patients with severe kidney insufficiency (Creatinin-Clearance less than 30 ml/min) 9. Patients with hereditary degenerative retinal disorders such as Retinitis pigmentosa 10. Patients suffering from loss of vision on one eye due to Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) 11. Patients with anatomical deformation of penis, such as angulation, cavernosal fibrosis or Peyronie´s disease 12. Known hypersensitivity to Sildenafil, Alprostadil or any compound of the trial medication 13. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 14. Any of the investigational drugs taken four weeks prior to screening 15. Patients who are currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis 16. Patients being treated with alpha blockers for therapy of arterial hypertension 17. Patients who are receiving concomitant treatment with CYP3A4 inhibitor (e.g. ritonavir) 18. Alcohol or drug abuse 19. Participation in any other trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable is the IIEF-EF domain score (six questions) measured at week 42, after 36 weeks of treatment and a therapy-free interval of six weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: 1. IIEF-EF domain score (six questions) after week four, 12, 24, 36, and 52. 2. IIEF domain score (15 questions) after week four, 12, 24, 36, 42 and 52. 3. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) after week four, 12, 24, 36, 42 and 52. 4. Patient satisfaction measured by patient diary during week five, week 13, 25, 37, 42 and 51. 5. Proportion of patients achieving a normal IIEF-EF domain score (more than 25) in week four, 12, 24, 36, 42 and 52. | — |
Countries
Germany
Outcome results
None listed