Recalled International Index of Erectile Function-5 Collected Post Prostatectomy in Assessing Preop Erectile Function

Erectile Dysfunction Following Radical Prostatectomy Clinical Trial

Official title:

Recalled International Index of Erectile Function-5 Collected 3 Months Postoperatively in Assessing Preoperative Erectile Function in Patients Undergoing Radical Prostatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05272995
• Other study ID #: 114/21-02-2022
• Status: Recruiting
• Start date: February 24, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: March 2022
• Source: University Hospital of Patras
• Contact: Stavros Kontogiannis
• Phone: 00306974678699
• Email: stavroskontogiannis[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunction Following Radical Prostatectomy

Intervention

Diagnostic Test:
• IIEF-5
The participants will be asked to complete a validated IIEF-5 questionnaire, an abridged version of the IIEF. The IIEF is a validated, brief and reliable self-administered questionnaire for assessing erectile function. Moreover, this tool is easily administered in clinical setting and demonstrates adequate sensitivity and specificity for detecting treatment-related changes in erectile function in patients with erectile dysfunction (ED).According to Rosen et al the abridged five-item version of the 15-item IIEF possesses favorable properties for detecting the presence and severity of ED for the preceding 6 months. The IIEF-5 consists of five questions, each of which is scored on a five-point ordinal scale and ED may be classified into five categories based on the calculated scores.

Locations

Country	Name	City	State
Greece	University of Patras	Patras	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of recalled International Index of Erectile Function-5	Score of recalled IIEF-5 collected 3 months after radical prostatectomy. The IIEF is a validated, brief and reliable self-administered questionnaire for assessing erectile function. The abridged five-item version of the 15-item IIEF possesses favorable properties for detecting the presence and severity of erectile dysfunction for the preceding 6 months. The IIEF-5 consists of five questions, each of which is scored on a five-point ordinal scale and erectile dysfunction may be classified into five categories based on the calculated scores. Based on IIEF-5 scores, erectile dysfunction severity is classified into the following five categories: severe (5±7), moderate (8±11), mild to moderate (12±16), mild (17±21), and no erectile dysfunction (22± 25).	3 months
Primary	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	Assessment of the degree of agreement between real time preoperative IIEF-5 score and recalled IIEF-5 3 months after radical prostatectomy	3 months