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

NCT05272995 | Unknown

• 1 other identifier: 114/21-02-2022
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Keywords

Erectile dysfunction; Prostate cancer; IIEF-5; Radical prostatectomy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

IIEF-5 DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

University of Patras

Pátrai, Achaia, 26504, Greece

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases

Study Officials

• Stavros Kontogiannis

  University of Patras

  STUDY DIRECTOR

Central Study Contacts

Stavros Kontogiannis

CONTACT

00306974678699; stavroskontogiannis@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant of Urology

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 10, 2022
• Study Start: February 24, 2022
• Primary Completion: July 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 25, 2022

Record last verified: 2022-03

Locations

GR (1)