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Trial registered on ANZCTR


Registration number
ACTRN12612000235808
Ethics application status
Approved
Date submitted
8/02/2012
Date registered
24/02/2012
Date last updated
2/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is penile prosthesis implantation for severe male impotence a satisfactory treatment for both patient and sexual partner and why?
Scientific title
Assessing predicting factors of satisfaction for patients with refractory erectile dysfunction and their female partners from penile prosthesis implantation
Secondary ID [1] 279905 0
Nil
Universal Trial Number (UTN)
U1111-1128-0493
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractory erectile dysfunction 285813 0
Condition category
Condition code
Renal and Urogenital 285990 285990 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 286002 286002 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ipmplantation of penile prosthesis in patients with refractory erectile dysfunction
Penile prosthesis is a three pieces inflatable by normal saline hydraulic device, consisting by two cylinders implanted in the corpora cavernosa, connected by a tube with an operating pump implanted in the scrotum, which is also connected by a tube with a reservoir containing the saline, implanted in Regius space.
Implantation procedure of three pieces is accomplished through a single penoscrotal incision and it lasts about one hour
Intervention code [1] 284229 0
Treatment: Surgery
Intervention code [2] 284230 0
Treatment: Devices
Comparator / control treatment
Comparison of sexual satisfaction of patient and sexual partner before and after treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286481 0
Satisfaction of patients with refractory erectile dysfunction and their sexual partners, after penile prosthesis implantation by using the Erectile Dysfunction Inventory of Treatment Satisfaction ( EDITS) Patient and Partner Versions
Timepoint [1] 286481 0
Patients fill up questionnaires on 12th, 24th and 36th month postoperatively
Primary outcome [2] 286482 0
Correlation between patients and partners sexual satisfaction by statistical analysis
Timepoint [2] 286482 0
Patients fill up questionnaires on 12th, 24th and 36th month postoperatively
Primary outcome [3] 286483 0
Assessment of various predicting factors resulting in patients satisfaction or dissatisfaction by using EDITS questionnaire
Timepoint [3] 286483 0
Patients fill up questionnaires on 12th, 24th and 36th month postoperatively
Secondary outcome [1] 295990 0
Surgical complications after the operation using the modified Clavien System.
Timepoint [1] 295990 0
All the complications are going to be recorded during the early and late postoperatively day. On dishcarge day and in 30 days postoperatively.
Secondary outcome [2] 298161 0
Long term complications of the penile prothesis. Mechanical failure, fracture, infection, revision surgery, withdrawl, exchange.
Timepoint [2] 298161 0
On 24th, 36th, 48th month postoperatively.

Eligibility
Key inclusion criteria
1.Patients with refractory to oral and intracavernosal injection treatment erectile dysfunction not allowing sexual intercourse .
2.Contraindication for oral and intracavernosal injection treatment for patients with erectile dysfunction not allowing sexual intercourse.
3.Unwilling for oral and intracavernosal injection treatment patients with erectile dysfunction not allowing sexual intercourse.
4. Patients with refractory to oral treatment erectile dysfunction not allowing sexual intercourse, who do not wish to receive intracavernosal injections
Minimum age
No limit
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1.Patients with erectile dysfunction safely curable by oral or intracavernosal injection treatment
2.Patients, who despite their refractory erectile dysfunction in oral and intracavernosal injection treatment, can have sexual intercourse

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4121 0
Greece
State/province [1] 4121 0
Thessaloniki

Funding & Sponsors
Funding source category [1] 284676 0
Self funded/Unfunded
Name [1] 284676 0
Address [1] 284676 0
Country [1] 284676 0
Primary sponsor type
University
Name
Aristotle University of Thessaloniki
Address
81A Egnatia Str
54635 Thessaloniki
Country
Greece
Secondary sponsor category [1] 283580 0
None
Name [1] 283580 0
Address [1] 283580 0
Country [1] 283580 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The aims of the study are to assess patients with refractory erectile dysfunction and their sexual partners satisfaction, after implantation of penile prosthesis, to correlate the potential satisfaction between both partners after treatment and to determinate the factors resulting in this potential satisfaction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33754 0
Address 33754 0
Country 33754 0
Phone 33754 0
Fax 33754 0
Email 33754 0
Contact person for public queries
Name 17001 0
Ioannis Vakalopoulos
Address 17001 0
81A Egnatia Str
54635 Thessaloniki
Country 17001 0
Greece
Phone 17001 0
+30 2310 269222
Fax 17001 0
Email 17001 0
vakalj@otenet.gr
Contact person for scientific queries
Name 7929 0
Ioannis Vakalopoulos
Address 7929 0
81A Egnatia Str
54635 Thessaloniki
Country 7929 0
Greece
Phone 7929 0
+30 2310 269222
Fax 7929 0
Email 7929 0
vakalj@otenet.gr

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary