Clinical trial NCT05272995: Recalled International Index of Erectile Function-5 Collected Post Prostatectomy in Assessing Preop Erectile Function
Official title: Recalled International Index of Erectile Function-5 Collected 3 Months Postoperatively in Assessing Preoperative Erectile Function in Patients Undergoing Radical Prostatectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Erectile Dysfunction Following Radical Prostatectomy
Keywords: Erectile dysfunction
Prostate cancer
IIEF-5
Radical prostatectomy
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men above 18 years old wih clinically localized prostate cancer, who have undergone open or laparoscopic radical prostatectomy

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.

Eligibility criteria: Inclusion Criteria:

* Men above 18 years old wih clinically localized prostate cancer, who have undergone open or laparoscopic radical prostatectomy, with or without use of phosphoodiesterase-5 inhibitors

Exclusion Criteria:

* Penile anatomic defects
* Uncontrolled major medical illnesses such as uncontrolled diabetes, severe renal, hepatic or cardiovascular disease
* major psychiatrics disorders
* drug or alcohol abuse

Primary outcomes:
measure: Score of recalled International Index of Erectile Function-5
timeFrame: 3 months
measure: Assessment of the degree of agreement between real time preoperative International Index of Erectile Function-5 score and recalled IIEF-5 3 months after radical prostatectomy
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Patras
country: Greece
facility: University of Patras
state: Achaia
Study officials:
affiliation: University of Patras
name: Stavros Kontogiannis
role: STUDY_DIRECTOR
References: