Treatment of Peyronie's disease with hyperthermia, vitamin D and testosterone: a pilot randomised controlled trial
| ISRCTN | ISRCTN82950322 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82950322 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/09/2007
- Registration date
- 30/10/2007
- Last edited
- 25/02/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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 Carlos Cesar Cusmanich
Scientific
Scientific
Rua Oyapock , 67 Apart 101
Curitiba (State of Parana)
80050-450
Brazil
| Phone | +55 41 9976 4500 |
|---|---|
| cesarcus@onda.com.br |
Study information
| Study design | Pilot randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To evaluate the effectiveness and safety of the combination of hyperthermia, vitamin D and testosterone in the treatment of Peyronie's disease compared with hyperthermia alone. As of 25/02/2010 this record was updated to reflect a change to the study design of this trial. This is now a pilot randomised controlled trial instead of a randomised controlled trial. At this time, the anticipated trial dates were also updated; the previous anticipated trial dates were as follows: Initial anticipated start date: 26/09/2007 Initial anticipated end date: 26/03/2010 Also, the target number of participants has been amended from 60 participants to 20 participants. |
| Ethics approval(s) | Ethics approval received from the ethics committee of Hospital de Clinicas da Universidade Federal do Parana (Brazil) on the 19th September 2007 (ref: CAAE: 01730208000-07; CEP/HC: 1489.154/2007-07). |
| Health condition(s) or problem(s) studied | Peyronie's disease |
| Intervention | Please note that as of 06/02/2008 the anticipated end date of this trial was extended to 26/03/2010. The previous anticipated end date was 26/09/2008. Current interventions as of 25/02/2010: The interventions will take place with a duration of 16 weeks. At baseline, all patients will be analysed clinically and with lab exams: 1. Total and free testosterone 2. Prostate specific antigen (PSA) 3. Haemogram 4. Prolactin 5. Luteinising hormone (LH) 6. Digital rectal examination 7. Ultrasonography of penis and photos of penis during erection Patients will be randomised to: 1. Control group:10 patients will be treated with hyperthermia alone during 30 minutes/day with infrared laser applied directly over the plaque and curvature for 16 weeks. 2. Experimental group: 10 patients will be treated with hyperthermia (as above) plus Vitamin D 30.000 UI/day/oral and an injection of testosterone depot (Durateston®) every 10 days initially (patients with baseline levels of free testosterone under upper normal levels) All patients will have to return every month and levels of testosterone and vitamin D will be analysed (patients of the experimental group) to reach the goal of upper normal levels of free testosterone and maximum non-toxic normal level of vitamin D. At the end of 16 weeks, patients of the experimental group will have their levels of PSA and haemogram analysed as well as digital rectal examination. Both groups at the end of 16 weeks will have ultrasonography of penis and will take photos of their penis during erection. Initial information at time of registration: The interventions will take place over a duration of one year. At baseline, all patients will be analysed clinically and with lab exams: 1. Total and free testosterone 2. Prostate Specific Antigen (PSA) 3. Haemogram 4. Prolactin 5. Luteinising Hormone (LH) 6. Digital rectal examination 7. Ultrasonography of penis and photos of penis during erection Patients will be randomised to: 1. Control group: 30 patients will be treated with hyperthermia alone (30 minutes/day with infrared lamp of 150 W at a distance of approximately 20 cm of the plaque(s) and curvature) 2. Experimental group: 30 patients will be treated with hyperthermia (as above) plus Vitamin D (4000 IU/day/oral) and one injection of Testosterone depot (Durateston®) every 2 weeks initially (patients with baseline levels of free testosterone under median normal level) All patients will have to return every month and levels of testosterone and vitamin D will be analysed to reach the goal of median normal level of free testosterone and maximum normal level of vitamin D. Every 3 months, levels of PSA and Haemogram will be analysed and at 6 months and 1 year digital rectal examination and also ultrasonography and photos of penis on erection will be analysed. |
| Intervention type | Supplement |
| Primary outcome measure | 1. Decreased size of plaques, measured every month throughout the duration of the trial 2. Decreased curvature of penis, measured every month throughout the duration of the trial |
| Secondary outcome measures | 1. Improvement of sexual function, measured every month throughout the duration of the trial 2. Improvement of self-esteem, measured every month throughout the duration of the trial |
| Overall study start date | 01/04/2010 |
| Completion date | 01/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 20 patients |
| Key inclusion criteria | Patients with Peyronie's disease. |
| Key exclusion criteria | 1. Prostate cancer 2. Hyperprolactinaemia 3. Congestive heart failure 4. Severe dyslipidemia 5. Severe hypertension |
| Date of first enrolment | 01/04/2010 |
| Date of final enrolment | 01/04/2011 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Rua Oyapock , 67 Apart 101
Curitiba (State of Parana)
80050-450
Brazil
80050-450
Brazil
Sponsor information
Hospital de Clinicas da Universidade Federal do Paraná (UFPR) (Brazil)
Hospital/treatment centre
Hospital/treatment centre
c/o Miss Simone
Rua General Carneiro, 181
Curitiba (State of Parana)
80060-900
Brazil
| Website | http://www.hc.ufpr.br/ |
|---|---|
"ROR" |
https://ror.org/03ej9xm26 |
Funders
Funder type
Other
Investigator initiated and funded trial (Brazil)
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 |
