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

NCT ID: NCT05272995

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-24
• Study Completion Date: 2022-10-01

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.

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Patras

OTHER

Sponsor Role: lead

Responsible Party

Stavros Kontogiannis

Consultant of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stavros Kontogiannis

Role: STUDY_DIRECTOR

University of Patras

Locations

University of Patras

Pátrai, Achaia, Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Stavros Kontogiannis

Role: CONTACT

stavroskontogiannis@gmail.com

00306974678699

Facility Contacts

Ionanthi Kapatou

Role: primary

kapatou_ion@hotmail.com

00302613603385

Other Identifiers

114/21-02-2022

Identifier Type: -

Identifier Source: org_study_id