Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-30 @ 2:53 PM
Study NCT ID:
NCT05272995
Status:
UNKNOWN
Last Update Posted:
2022-03-25
First Post:
2022-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recalled International Index of Erectile Function-5 Collected Post Prostatectomy in Assessing Preop Erectile Function
Sponsor:
University Hospital of Patras
Organization:
Study Overview
Official Title:
Recalled International Index of Erectile Function-5 Collected 3 Months Postoperatively in Assessing Preoperative Erectile Function in Patients Undergoing Radical Prostatectomy
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The accurate assessment of erectile function before radical prostatectomy, using validated questionnaires like IIEF-5, is crucial to evaluate postoperative changes in erectile function, as the preoperative erectile function is a prognostic factor for the postoperative recovery of erectile function. In clinical practice, patients usually present at the urologist's office 3 months after the operation without a preoperative IIEF-5 score and at that time the doctors ask them about their preoperative erectile function. With this study, the investigators would like to evaluate the agreement between a real-time preoperative IIEF-5 and a recalled one 3 months after radical prostatectomy.
Detailed Description:
Radical prostatectomy (RP) is a widely performed procedure for patients with clinically localized prostate cancer and its most common side effects include urinary incontinence and erectile dysfunction. These two side-effects become progressively more important to health-related quality of life (HRQOL) and thus the balance between cancer control and preservation of HRQOL is challenging. The postoperative changes in erectile function are directly related with the preoperative erectile function status of the patient. The most accurate evaluation of the pretreatment erectile function is the International Index of Erectile Function-5 questionnaire. The fact that in some cases the preoperative questionnaire results are negatively affected by several factors, indicates the necessity of the assessment of the degree of agreement between real time IIEF-5 scores and retrospective IIEF-5 scores after radical prostatectomy. Frequently the andrologists do not have a preoperative IIEF-5 score in their hands and this might happen for various reasons. The main reason is that urologists ask about the preoperative erectile function often with just a simple question. They rarely use a questionnaire mainly due to time constraints. According to the experience at the Sexual Rehabilitation Clinic of the University's General Hospital of Patras, 3 months is the usual time point when most patients come to the clinic after radical prostatectomy. In the first two months after surgery, patients are interested primarily in the oncological and continence issues and later they seek help for their erectile dysfunction.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: