Multicentric prospective study for Therapy of Erectile Dysfunction After nerve sparing radical Prostatectomy: sildenafil (50 mg daily dosing) versus intracorporeal injection of alprostadil (2.5 µg - 10 µg 3/week)
| ISRCTN | ISRCTN32957197 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32957197 |
| Secondary identifying numbers | 2006-003-TEDAP |
- Submission date
- 01/08/2006
- Registration date
- 04/12/2006
- Last edited
- 18/10/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ludger Franzaring
Scientific
Scientific
Klinikum Bremen-Mitte gGmbH
St.-Jürgen-Str. 1
Bremen
D-28177
Germany
Study information
| Study design | Prospective, randomised, open-label, multicentre phase IV study with a parallel group design. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | TEDAP |
| Study objectives | Current hypothesis as of 25/01/2008: The trial objective is to demonstrate a non-inferior efficacy of Sildenafil 50 mg daily dosing (Viagra-Daily-Dosing [VDD] group) compared to intracorporeal injection of Alprostadil 2.5 µg - 10 µg thrice weekly (Intra-Corporeal Injection [ICI] group) as a therapeutic option after bilateral nerve sparing prostatectomy measured by International Index of Erectile Function (IIEF-EF) domain score after 36 weeks of treatment and after 6-weeks of therapy-free interval at week 42 (follow-up one). Previous hypothesis: The trial objective is to demonstrate a non-inferior efficacy of sildenafil 50 mg daily dosing (Viagra-Daily-Dosing group) compared to intracorporeal injection of alprostadil 10 µg thrice weekly (Intra-Corporeal Injection group) as a therapeutic option after bilateral nerve sparing prostatectomy measured by International Index of Erectile Function (IIEF-EF) domain score after 36 weeks of treatment and after six-weeks of therapy-free-interval at week 42 (follow-up one). Please note that as of 25/01/2008 this record was updated to show a difference in the dosage of alprostadil given to the participants. All changes relating to this update are shown in the relevant sections under the date 25/01/2008. Please also note that the title of this trial has changed from: 'Multicentric prospective study for Therapy of Erectile Dysfunction After nerve sparing radical Prostatectomy: sildenafil (50 mg daily dosing) versus intracorporeal injection of alprostadil (10 µg 3/week)' to the above-mentioned title. |
| Ethics approval(s) | Ethics approval received from the Mainz Ethics Committee (Germany) on the 25th January 2008 (ref: 837.258.06 (5356)). |
| Health condition(s) or problem(s) studied | Erectile dysfunction |
| Intervention | 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. Viagra® (VDD: Viagra-Daily-Dosing, 50 mg oral daily dosing), and 2. Caverject Impuls® (ICI: Intracorporeal injection, 10 µg three times weekly) The study was terminated prematurely on 02/11/2010 due to an unexpected high number of drop-outs in the Caverject® group. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Sildenafil and alprostadil |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 01/11/2006 |
| Completion date | 01/11/2009 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | It is planned to enroll 194 patients in the trial (Last patient out on 06/10/2010) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 01/11/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinikum Bremen-Mitte gGmbH
Bremen
D-28177
Germany
D-28177
Germany
Sponsor information
Johannes Gutenberg Universität Mainz (Germany)
University/education
University/education
c/o Professor Urban
Fachbereich Medizin
Langenbeckstr. 1
Mainz
D-55131
Germany
| Website | http://www.uni-mainz.de/eng/ |
|---|---|
"ROR" |
https://ror.org/023b0x485 |
Funders
Funder type
Industry
Pfizer Pharma GmbH (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
