The Use of IIEF-5 for Reporting Erectile Dysfunction Following Nerve-Sparing Radical Retropubic Prostatectomy

Introduction: Increased detection of organ-confined prostate cancer has led to an increased demand for nervesparing surgery. Most studies of erectile dysfunction (ED) following nerve-sparing radical prostatectomy (RRP) use single-item assessment, and potency rates differ widely among various groups. We aimed to investigate the use of the IIEF-5, a validated questionnaire, for reporting ED following RRP. Aims: To study the use of the IIEF-5 questionnaire in the evaluation of post-RRP ED, and to find possible variations in ED reporting when comparing IIEF-5 to single-item assessment. Methods: At a minimum of 18 months post-surgery, patients completed a questionnaire on erectile function that included both single-item assessment and the IIEF-5. The study included sexually active patients who reported no pre-operative ED and who did not receive adjuvant or salvage therapy. Main Outcome Measures: For the single-item assessment, potency was defined as “the ability to achieve erections firm enough for intercourse”. For the IIEF-5 questionnaire, potency was defined as a score >22 (out of 25) points. Results: Ninety-one patients were included in the study. The procedures consisted of bilateral nerve-sparing (55%) or unilateral or partial bilateral nerve-sparing surgery (45%). We found a striking difference in potency rates when using either IIEF-5 score or single-item assessment for reporting of potency after RRP. The results when using the IIEF-5 questionnaire indicated that 25.5% of all patients were potent. In contrast, single-item assessment indicated a potency rate of 53.8%. Conclusions: Using the IIEF-5 questionnaire to evaluate ED following RRP results in a remarkably lower percentage of men being classified as having no ED. This might be the main reason IIEF-5 is not frequently used in the reporting of ED following radical prostatectomy. Literature search reveals that the IIEF-5 questionnaire is expected to have a higher level of validity, accuracy, and reliability, and may be more stable than single-item assessment. We think that the use of IIEF-5 in the reporting of ED following RRP enhances comparison of different series and of different treatment modalities. However, a prospective comparison between IIEF-5 and single-item assessment is needed to confirm this finding. INTRODUCTION Prostate cancer is a medical problem affecting many men. An estimated 301.500 new cases are diagnosed each year in the European Union, where prostate cancer constitutes about 24% of all male cancers [1]. At present, radical retropubic prostatectomy (RRP) is the treatment of choice in young men with clinically localized prostate cancer [1]. Increased screening using prostate-specific antigen has resulted in the detection of mostly clinically localized prostate cancer at earlier stages and in younger men; therefore, patients undergoing radical prostatectomy generally have good baseline erectile function and high expectations concerning the preservation of erectile function following the procedure. Since Walsh et al. published their insights into the etiology and prevention of impotence following RRP in 1982, their nervesparing technique has been widely employed to improve postoperative erectile function. The anatomical techniques used in RRP results in decreased blood loss and thus better visualization and safer dissection of the neurovascular bundles [2, 3]. Many studies on erectile dysfunction (ED) following nerve-sparing RRP have been published, revealing widely disparate potency rates (30-86%) among various groups in different studies [4-11]. This variation in potency *Address correspondence to this author at the Department of Urology, University Hospital Leuven, Herestraat 49, B-3000 Leuven, Belgium; E-mail: [email protected] rates may be due to patient selection, surgeon and hospital volume, and the proportion of nerve-sparing procedures [5, 12-14]. However, non-uniform data-collection, the assessment method, and the definition of potency also influence the reported erectile function outcome [15-17]. A single-item assessment is used in most studies, with potency defined as “having erections firm enough for intercourse.” In concordance with the definition of ED introduced by the National Institutes of Health in 1992, ED is therefore the inability to attain and maintain erections firm enough for intercourse [18]. Although this single-item assessment has been used in many recent studies, the IIEF-5 may be a more standardized investigational technique for evaluating ED following RRP. Although it is widely accepted as a valid tool for evaluating ED, the IIEF-5 is used infrequently for the assessment of ED post-RRP [19-21]. We aimed to study the use of the IIEF-5 questionnaire in the evaluation of postoperative ED following nerve-sparing RRP and to compare the results to those obtained using single-item assessment. A questionnaire on the functional outcome of RRP was sent to 272 men who had undergone nerve-sparing RRP, and an extensive chart review was performed. AIMS The aims of this study were to evaluate the use of the IIEF-5 questionnaire for reporting ED following RRP, to 2 The Open Prostate Cancer Journal, 2009, Volume 2 Albersen et al. find possible variations when comparing IIEF-5 to singleitem assessment and to report the functional and oncological results of nerve-sparing RRP at our institution. PATIENTS AND METHODS Two-hundred-and-seventy-two patients underwent open nerve-sparing RRP: 45% were classified as unilateralor partial bilateral nerve-sparing (UNS/PBNS) and 55% as bilateral nerve-sparing (BNS). Clinical Staging Local tumor staging was performed by digital rectal examination, transrectal ultrasound with biopsy, and, in some cases, MRI. Ten at random biopsies were taken from all patients and were scored according to the Gleason scoring system. A bone scan and CT of the pelvis and abdomen were performed to assess bone metastases and lymph node involvement when PSA was >10 ng/ml, when the clinical stage was T3 or when the Gleason score was > 7. Surgical Technique Two surgeons (HVP, SJ) performed all procedures. Before performing the radical prostatectomy, all patients underwent a bilateral staging pelvic lymph node dissection without frozen section. The nerve-sparing technique was performed by a modified Walsh tehnique, [3, 22] with avoidance of use of clips and electrocautery near the neurovascular bundle, the accessory pudendal arteries, and the pudendal branch that innervates the extrinsic sphincter of the urethra (which runs dorsal to the sphincter complex). Pathological Staging The RRP specimens, including prostate, seminal vesicles, and bilateral pelvic lymph nodes, were examined microscopically after routine preparation. The prostate was weighed and cut as whole-mount 4-mm sections. All specimens were scored according to the Gleason grading system. Microscopic extension of malignant cells to the inked surface of the resected specimen was interpreted as a positive surgical margin. The pathological stages were recorded as pT2a, pT2b, pT2c, pT3a, pT3b, or pT4 and lymph node status was assigned according to the 2002 TNM classification [23]. Postoperative Care and Follow-Up Patients had an indwelling silicone catheter for two weeks. Pelvic floor muscle exercises were started at catheter removal. Patients were evaluated at the outpatient clinic at 6 weeks, 3, 6, and 12 months after surgery, and every 6 months thereafter. Data Collection At a minimum follow-up of 18 months after surgery, a combined questionnaire was mailed to all 272 RRP patients (Appendix). Each patient was asked about preand postoperative potency (single-item assessment). Potency was scored as follows: 0: absence of tumescence or presence of erection not rigid enough for penetration (no recovery) or 1: erection that was rigid enough to allow penetration (full recovery). Patients also received an IIEF-5 questionnaire which is an abridged version of the validated International Index of Erectile Function questionnaire. The IIEF-5 consists of four questions derived from the erectile function domain and one question from the intercourse satisfaction domain of the IIEF. A cut-off score of > 22 (out of 25) points was used as the definition of potency. All patients were also asked about their use of potency-enhancing medication or devices and about their ability to achieve orgasm. Further, an extensive chart review was performed, and technical aspects of the procedure were noted. These aspects included the surgeon, blood loss, duration, and a score for the technical difficulty of the procedure as determined by the surgeon, ranging from 1 (easy) to 3 (difficult). If nerve preservation was attempted but complicated by bleeding, fibrosis, or other causes, it was noted as partially nerve-sparing on that side. Two categories of nerve-sparing surgery were noted, namely BNS or UNS/PBNS. Inclusion and Exclusion Criteria Patients who received adjuvant therapy and patients who reported an absence of erections rigid enough for intromission (using the single-item assessment) preoperatively were excluded. Using the IIEF-5, nonsexually active patients would be classified as having severe ED, since the score would be 0 for four of the five questions (Appendix). Therefore, for inclusion in the study, patients had to be sexually active. Statistical Analysis We used Cox univariate regression analysis for statistical analysis of the functional outcome predictors. The chi-square test was used for comparison of proportions when comparing outcomes with different definitions of ED. For all evaluations, the level of significance was set at P = 0.05. For statistical analysis, we used the software MedCalc ® (version 8.1.1.0). RESULTS Using the IIEF-5 to Evaluate ED A chart review was performed for the 272 patients in the study (Table 1). The mean patient age was 58.2 + 6.4 years (range: 45 to 70 years). Of the 272 patients who underwent RRP, 195 completed and returned the questionnaire; 15 of the 195 patients were excluded because they recieved adjuvant therapy, and 19 of the 195 patients were excluded because preoperatively they had no erections or erections not rigid enough for intromission. Of the remaining 161 patients, 70 were not sexually active when they filled out the questionnaire; thus, only 91 patients were included in the study. Of these 91 patients, 45% underwent UNS/PBNS; the remaining 55% had BNS surgery. ED was assessed regardless of whether potency-enhancing devices or medication were used. We analyzed the influence of the questioning method on reporting of postoperative erectile function in 161 patients, and assessed potency rates in the subgroup of patients that reported being sexually active (n = 91). Using single-item assessment to assess whether erections sufficient for intromission were present, the overall full recovery rate was found to be 53.8%. However, of the patients that were sexually The Use of IIEF-5 for Reporting Erectile Dysfunction The Open Prostate Cancer Journal, 2009, Volume 2 3 active, only 25.5% had an IIEF-5 score of 22-25 points (i.e. no ED). This difference was statistically significant (P = 0.001). This difference in reported results between methods was present in all age groups (Fig. 2) and in the UNS/PBNS as well as the BNS surgery group (Fig. 3). The mean IIEF-5 score in all 91 sexually active patients was 16.27 points (95% CI: 14.97 to 17.58). At the time of the study, 31.2% of the 91 patients reported use of a PDE-5 inhibitor, 2.5% used intracavernous injection therapy, and one patient reported using a vacuum tumescence device. Univariate analysis of the predictors for erectile function showed that recovery of