Use of a Validated Quality of Life Questionnaire to Assess Sexual Function Following Laparoscopic Radical Prostatectomy

ORIGINAL ARTICLE Use of a validated quality of life questionnaire to assess sexual function following laparoscopic radical prostatectomy

A Wagner, R Link, C Pavlovich, W Sullivan and L Su

James Buchanan Brady Urological Institute, Johns Hopkins University, Baltimore, MD, USA

Wide variations exist in the methods for evaluating potency following radical prostatectomy. We describe our technique of laparoscopic radical prostatectomy (LRP), present our methods for assessing the return of potency following LRP, and discuss the relevant literature. Sexual function was assessed pre- and postoperatively using the Expanded Prostate Cancer Index Composite questionnaire (EPIC). Sexual function subscale scores (SFSS) were reported as a percentage of preoperative baseline sexual function. The EPIC was also used for single-question assessment of successful intercourse. We also reviewed the literature on prospective health-related quality of life results following LRP and open radical retropubic prostatectomy. Only patients reporting preoperative intercourse were analyzed. Of these, 72 and 35% undergoing bilateral and unilateral nerve sparing (NS) reported postoperative intercourse at 12 months (P ¼ 0.01). Mean SFSS at 12 months was 61 and 57% of baseline after bilateral and unilateral NS, respectively (P ¼ 0.71). Following NS procedures, 74% of patients p58 years of age and 41% of patients 458 years of age reported successful intercourse at 12 months (P ¼ 0.015). Mean SFSS was 64 and 52% of baseline function (P ¼ 0.249) at 12 months for patients p58 and 458 years of age, respectively. In patients o58 years of age who underwent bilateral NS surgery, 82% reported intercourse at 12 months. In conclusion, return of sexual function following NS LRP in our experience is comparable to reports from centers of excellence in open prostatectomy. Standardizing data collection using validated quality of life instruments can provide both surgeon and patient with a realistic forecast of relative return to normal sexual function following prostatectomy. International Journal of Impotence Research (2006) 18, 69–76. doi:10.1038/sj.ijir.3901376; published online 11 August 2005

Keywords: prostatectomy; quality of life; laparoscopy

Introduction geons have also refined surgical technique to allow for decreased blood loss and better visualization of Inherent in determining the relative success of any the external striated sphincter and urethra, thus treatment modality for localized prostate cancer is achieving continence rates of 490%.3,4 In contrast the assessment of three main outcome measures: to the success observed with oncologic and con- cancer cure, preservation of urinary continence, and tinence end points, the preservation of postopera- return of sexual function. Since the mid-1900s tive sexual function has been far less consistent. surgical treatment of prostate cancer has been Wide variations exist in reported potency rates considered the standard by which other therapies following RRP.4–8 Single surgeon case series de- have been compared. High-volume radical retro- scribe potency rates from 76 to 86% in those men pubic prostatectomy (RRP) centers report excellent undergoing bilateral nerve sparing (NS) proce- oncologic success as measured by 10-year biochem- dures.4,8 Others have reported potency rates after ical-free survivals of 68–85%.1,2 Experienced sur- NS surgery as low as 21%, suggesting that case series are not representative of more global prostatectomy outcomes.5,9,10 The reason for this wide variation is multifactorial. To begin with, erections, Correspondence: Dr A Wagner, James Buchanan Brady Urological Institute, Johns Hopkins University, 4940 East- unlike continence, are dependent not only upon ern Avenue, Baltimore, MD 21224, USA. physiologic factors such as cavernous nerve func- E-mail: [email protected] tion, but also upon various psychological, behavior- Received 31 May 2005; revised 23 June 2005; accepted 29 al, and social factors. Therefore, inherent difficulties June 2005; published online 11 August 2005 exist when critically evaluating a single variable (i.e. Use of a validated quality of life questionnaire A Wagner et al 70 neurovascular bundle (NVB) preservation during cautery is avoided during seminal vesicle dissec- prostatectomy) without the ability to control the tion. The posterior dissection of the prostate gland is remaining variables. Second, comparing studies accomplished by dissecting between Denonvillier’s from different institutions or national databases is fascia and the rectum. Access is then gained to the confounded by differences in patient selection, anterior prostate by dividing the urachus and experience/skill of the surgeons, surgical technique, entering the prevesical space of Retzius. The dorsal and the often-subjective assessment of NVB pre- venous complex is ligated using intracorporeal servation. Lastly, differing terminology is used to suturing with 2–0 polyglactin suture. define successful postoperative sexual function The endopelvic fascia along the lateral aspect of (e.g. spontaneous erections vs successful inter- the prostate is sharply incised, thus exposing the course) and differing methods of data collection periprostatic fascial planes. The NVBs run along the (e.g. physician inquiry vs patient-reported validated posterolateral surface of the prostate and lie within survey) have been used in different studies. Taken an outer levator fascia and inner prostatic fascia together, these vagaries make it difficult for both (Figure 1). In efforts to preserve the NVBs, bilateral surgeons and patients to realistically predict return NVB ‘grooves’ are created on the anterolateral aspect of normal sexual function following prostatectomy. of the prostate. To avoid iatrogenic entry into the Laparoscopic radical prostatectomy (LRP) has its prostate gland, the levator fascia is superficially basis in the anatomic RRP but enjoys the benefits of grasped and lifted off of the prostate, allowing a improved cosmesis, reduced blood loss, and shorter small incision to be made through this layer and postoperative convalescence typical of laparoscopic exposing the underlying prostatic fascia. The pro- surgery.11 Although it will require at least 10-year static fascia appears smooth, glistening and white, follow-up to fully evaluate the oncologic success of visibly different than the prostate parenchyma, LRP, the functional results of LRP from experienced which appears tan in color and more granular in centers appear comparable to most RRP series.12,13 texture. On occasion, large prostatic veins (i.e. Recently, there has been increased emphasis venous branches of the deep dorsal venous com- on patient-reported health-related quality of life plex) are encountered between the periprostatic (HRQOL) outcomes following treatment for prostate fascial layers. In this instance, when possible, cancer.5,10,12,14–17 Investigators have also developed dissection should be carried out deep to these veins validated instruments that were purposely designed as they travel between the levator and prostatic to address the prostate-specific domains of urinary, fascia. Once the prostatic fascia is identified, the bowel, and sexual function.18 Pre- and postoperative precise plane between the levator and prostatic assessment of HRQOL using these questionnaires fascia is then gently and bluntly developed using a allows each patient to serve as his own internal fine-tipped right-angled clamp along the anterolat- control, and is an ideal method of determining long- eral surface of the prostate starting at the base and term functional outcome in each specified domain. working towards the apex with the levator fascia In this manuscript, the authors will detail a method incised along the way. Electrocautery is minimized of pre- and postoperative assessment of sexual during this dissection so as to avoid thermal injury function that can be used to provide patients with to the cavernous nerves.21 Dissection also continues a greater understanding of the likelihood, timing, and relative return to baseline sexual function following LRP.

Methods

Operative technique We have previously described our technique of LRP,19 which is accomplished using a modification of the Montsouris technique.20 Our modifications have to do primarily with NVB preservation and are detailed here. Briefly, the patient is placed in the Trendelenburg position on the operating table. After CO2 gas insufflation of the peritoneal cavity, four to five laparoscopic trocars are placed in an inverted U-shaped configuration below the umbilicus. Retro- vesical dissection of the vas deferentia and seminal Figure 1 Periprostatic fascial planes with reference to the location of the neurovascular bundles. The dashed line indicates vesicles is first performed. As the cavernous nerves the course of interfascial dissection to optimize preservation of to the penis travel within the NVB and course the neurovascular bundle (Copyright 2005, Johns Hopkins within millimeters of the seminal vesicles, electro- University).

International Journal of Impotence Research Use of a validated quality of life questionnaire A Wagner et al 71 deeper in a posterolateral direction and the NVBs on a per patient basis to 100%. Sexual function are meticulously released bilaterally from the pros- subscale scores (SFSS) at 3, 6, and 12 months tate resulting in two visible NVB bundle ‘grooves’. following LRP were calculated and reported as a This initial step serves to establish the proper plane percentage of baseline function for each individual for future antegrade dissection (i.e. from prostatic patient. By collecting baseline data, each patient base to apex) and preservation of the NVBs. served as his own control, allowing our results to The prostate base is transected from the bladder reflect each patient’s individual return of sexual using ultrasonic shears until the previously dis- function compared to his unique baseline HRQOL sected seminal vesicles and vas deferentia are scores. Those patients who did not fully complete identified along the midline. Ligation of the pro- the SFSS portion of the EPIC were excluded from static pedicles at the 5 and 7 O’clock positions that analysis. is accomplished using hemoclips. Using the pre- Traditional single-question method for assessing viously established NVB ‘grooves’ as a guide, the postoperative sexual function was also determined remaining attachments between the NVB and pros- using responses to EPIC item #63 (‘During the last 4 tate are released in an antegrade direction towards weeks, how often did you have sexual inter- the prostatic apex. Dissecting close to the prostatic course?’), coding any response other than ‘not at fascia during NVB dissection optimizes quantitative all’ as a categorical affirmative for potency. Patients cavernous nerve preservation. Small hemoclips are were considered potent when reporting intercourse used to secure traversing vessels between the NVB with or without the assistance of phosphodiesterase- and prostate and electrocautery is avoided. 5 inhibitors (PDE-5I). Patients using other therapies The prostatic apex is divided from the urethra such as the vacuum erection device, intraurethral after transection of the dorsal venous complex. The prostaglandin, penile injection therapy, or penile apical attachments between the prostate and NVBs prosthesis were not included as potent. are gently released thus completing the bilateral NVB dissection. A watertight vesicourethral anastomosis is created using interrupted polyglactin Statistical analysis sutures and an 18-French foley catheter is placed EPIC scores were calculated using SAS software before completion of the anastomosis. A closed- (SAS Institute, Cary, NC, USA) and a scoring macro suction pelvic drain is left at the end of the available from the University of Michigan (http:// operation and the prostate specimen is delivered roadrunner.cancer.med.umich.edu/epic/epicmain. through the umbilical incision prior to trocar-site html). To compare mean values at a single time closure. point for two different patient cohorts (i.e. stratified by age or NVB preservation status), the Student’s T-test was used with statistical significance defined as a P-value o0.05. Assessment of sexual function Sexual function was assessed using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire, a validated quality of life instrument Results developed specifically for the assessment of post- treatment quality of life in men with prostate cancer. A total of 220 patients who have undergone LRP at The EPIC was developed at the University of our institution have at least 3-month follow-up data Michigan and based on the previous UCLA-Prostate available for analysis. In all, 164/220 (75%) reported Cancer Index (UCLA-PCI).18 The EPIC can be preoperative intercourse as measured by their divided into domains for domain-specific analysis answer to question 63 of EPIC and these patients (urinary, bowel, sexual, hormonal), and into do- are the focus of this analysis. The mean age of this main-specific subscales, such as the sexual function study cohort was 58 years (range 41–75). A total of and sexual bother subscales. For this analysis, 10 (6%), 45 (27%), and 109 (66%) of these men we focused on the sexual function subscale, as underwent non-, unilateral, and bilateral NS, it provides the best EPIC-derived assessment of respectively. For this cohort, 144, 114, and 60 erectile performance. patients had 3, 6, and 12 month EPIC data available Questionnaires were administered to patients for analysis. privately and collected by research staff preoperatively and at 3, 6, and 12 months following LRP according to a protocol approved by our Institu- Effect of NS status on return of postoperative sexual tional Review Board. Only patients with preopera- function tive EPIC data and at least one later time point (3 We evaluated the impact of NS status on return of months or beyond) were included, resulting in a sexual function. Figure 1a displays the single final study cohort of 220 patients. Baseline EPIC question assessment of postoperative potency based sexual domain and subscale scores were normalized on the degree of NS (unilateral vs bilateral) during

International Journal of Impotence Research Use of a validated quality of life questionnaire A Wagner et al 72 the first postoperative year. In the unilateral NS compare results from different investigators. More- group, improvement in reported potency was noted over, surgeon assessments of quality of life are often between 3 and 6 months with little change at 12 at odds with data collected directly from patients.24 months. Conversely, in the bilateral NS group, Analysis of data obtained from patients using postoperative potency continued to improve during comprehensive validated HRQOL surveys may help the postoperative study period with 72% of these to clarify postoperative expectations with regards to patients reporting successful intercourse at 12 both the likelihood and relative quality of sexual months. This is in contrast to only 35% of unilateral function following NS prostatectomy. NS patients reporting successful intercourse at 12 Excellent potency outcomes following RRP months (P ¼ 0.01). Mean sexual function SFSS as have been reported from single-surgeon series. a percentage of baseline preoperative function, and Walsh et al.4 prospectively evaluated 64 potent stratified based on NS status is shown in Figure 1b. men following RRP. Potency was determined At 12 months, mean SFSS after bilateral NS was using patient questionnaires with success defined 61% of baseline and after unilateral NS was 57% by an affirmative response to the question ‘over of baseline (P ¼ 0.710). the last 4 weeks did you have vaginal or anal intercourse?’. After preserving the NVBs in 89% of patients, 86% regained potency at 18 months. In Catalona’s series of over 3000 patients, 76% of Effect of patient age on return of postoperative preoperatively potent men with bilateral NS proce- sexual function dures were potent at 18 months. Return of potency In preoperatively potent patients undergoing NS was associated with age as 85 and 71% of men LRP (unilateral or bilateral), single question assess- in their 50s and 60s regained erections, respec- ment of intercourse was stratified by patient age tively.8 Potency was not defined in this paper and (Figure 2a). The mean age of our patient population, much of the data were surgeon collected. Never- 58 years, provided a convenient fulcrum for age- theless, these single-surgeon series show that most related analysis of potency and as expected, there patients can regain erections following NS surgery was a significant difference in potency at 6 and 12 performed by experienced, high-volume surgeons, months depending on age. At 6 months, 57% of although information regarding the quality of 4 patients p58 years of age and 29% of patients 58 erectile function was not provided by these studies. years of age reported intercourse (P ¼ 0.005). At 12 Despite their surgical expertise, the patient selec- months these results increased to 74 vs 41%, tion biases and high surgical volume inherent to respectively (P ¼ 0.015). When we looked specifi- these referral-based practices are not typical of cally at patients after bilateral NS surgery, 82% most urology practices. Multisurgeon, patient- (n ¼ 22) and 57% (n ¼ 14) of patients 58 and 458 p reported HRQOL analysis from a single institution years of age, respectively, reported intercourse at has revealed a significantly lower potency rate 12 months (P ¼ 0.107). Figure 2b examines age as a following RRP. Talcott et al.25 reported only 9% function of postoperative SFSS in patients following of preoperatively potent patients had erections a NS procedure. Mean SFSS were 64 and 41% of sufficient for intercourse 12 months after RRP baseline function at 6 months (P ¼ 0.009), and 64 at a tertiary academic center despite NS surgery in and 52% of baseline function at 12 months the majority of patients. (P ¼ 0.249) for patients 58 and 458 years of age, p Other investigators have used pooled patient respectively. outcomes from national databases to determine the sexual function of patients treated in the community. Stanford et al. used the Surveillance, Epide- Discussion miology and End Results (SEER) database to evaluate 1291 men following RRP. Of patients With regards to erectile function following prosta- undergoing bilateral NS procedures, 44% were tectomy, there is a large disparity in reported potent at 18 months. Age was also assessed with potency and little consistency in the methods used younger patients reporting better overall function to evaluate potency pre- and post-treatment. Indivi- (39% potent for o60 years of age; 15.3% potent dual probabilities for recovery of sexual function for ages 65–74).9 Although this study had an depend in part on the patient’s preoperative sexual impressive number of unselected patients, it did function and age.3,9 Other variables that have the not include an assessment of sexual function prior potential to affect potency following prostatectomy to prostatectomy. include surgical approach (retropubic, perineal, LRP was refined primarily in European centers laparoscopic, or robotic assisted), degree of caver- and early series were reported by groups with nous nerve preservation, surgeon skill and experi- extensive laparoscopic and open surgical experience, and hospital prostatectomy volume.22,23 ence.26–30 Large-volume centers have described Without a standardized method of evaluating sexual continence and early oncologic results comparable function, it is difficult or even impossible to to open surgery.12,13,31,32 Recovery of sexual func-

International Journal of Impotence Research Use of a validated quality of life questionnaire A Wagner et al 73 a 100%

90%

80% * p = 0.010

70%

60%

p = 0.392 50% intercourse 40% p = 0.154

30% % of men reporting postoperative

20%

10%

0% 3612 unilateral NS 20% (41) 39% (31) 35% (17) bilateral NS 32% (92) 48% (71) 72% (36) Months after LRP b 100% 100% Unilateral NS 90% Bilateral NS

80% p = 0.528 p = 0.710 70%

59% (19) 61% (27) 60% * p = 0.050 57% (14)

50% 42% (67)

53% (54)

function 40%

% of baseline sexual 30%

29% (30) 20%

10%

0% 036912 Months after LRP

Figure 2 (a) Single question assessment of postoperative intercourse stratified by NS status in men who were potent prior to LRP. (b) Mean sexual function subscale score (SFSS) during the first postoperative year expressed as a percentage of baseline preoperative function stratified by NS status in men who were potent prior to LRP. Error bars represent standard error and number of patients at each point is noted in parentheses. tion following LRP has also been reported to be bilateral NS LRP in our study population compares comparable to open series.13,27,29,33–36 Unfortu- favorably to patient-reported potency of 53–67% nately, these studies have used varying methods of following bilateral NS LRP in other reported evaluating pre- and postoperative potency and none series.13,35,36 Several groups have directly compared utilize the global sexual domain scores included in LRP to RRP and found a similar recovery of sexual EPIC. Nevertheless, the 72% potency rate following function between the two techniques.13,35,36

International Journal of Impotence Research Use of a validated quality of life questionnaire A Wagner et al 74 By combining single question with EPIC sub- sexual function following surgery. When examining domain analysis, we sought to facilitate patient the effect of NS, based on single question assess- expectations of long-term recovery of sexual func- ment of successful intercourse, 72 and 35% of those tion following LRP based upon the status of NVB undergoing bilateral and unilateral NS, respectively, preservation, age, and preoperative sexual function. reported intercourse at 12 months. Using the SFSS We focused this analysis on those patients reporting from EPIC, we formulated a more global assessment preoperative intercourse as they are most likely to of return to ‘normal’ preoperative sexual function experience the greatest potential impact on their with each individual patient serving as his own

a 100%

90% ≤ 58 ≥ 59 * p = 0.015 80% 74% (31)

70% * p = 0.005

60% 57% (60)

50%

41% (22) p = 0.091 40% % of men reporting postop intercourse 33% (78) 29% (42) 30%

20% (55) 20%

10%

0% 3612 Months after LRP

b 100% 100%

90%

80% * p = 0.009 p = 0.249

70% 64% (44) 64% (27) 60% p = 0.436 52% (14) 50% 40% (57) function 40% 41% (29) % of baseline sexual

30% 35% (40) ≤ 58 20% ≥ 59 10%

0% 036912 Months after surgery Figure 3 (a) Single question assessment of postoperative intercourse stratified by patient age in preoperatively potent men who underwent NS LRP. (b) Mean SFSS during the first postoperative year expressed as a percentage of baseline preoperative function stratified by patient age in preoperatively potent men who underwent NS LRP. Error bars represent s.e. and number of patients at each point is noted in parentheses.

International Journal of Impotence Research Use of a validated quality of life questionnaire A Wagner et al 75 control. To our surprise SFSS for unilateral and 24 months following surgery.15,16 Therefore, we bilateral NS patients were similar (i.e. 57 vs 61% anticipate continued improvement in sexual func- of baseline function, respectively, P ¼ 0.71) despite tion as follow-up extends beyond 1 year. Continued a significantly higher percentage of men in the longitudinal follow-up with the EPIC questionnaire bilateral cohort reporting successful intercourse. in our LRP patients is ongoing at our institution. This similarity may have several explanations including simply a lack of sufficient sample size to detect a difference between the two groups. This finding may also result from a difference in baseline Conclusions SFSS between the uni- and bilateral NS groups. There is a disheartening lack of uniformity in Interestingly, we found the mean baseline raw SFSS measuring baseline and postoperative sexual func- to be 65 and 72 in the uni- and bilateral groups, respectively (P ¼ 0.017). This higher baseline SFSS tion following radical prostatectomy. Many early studies relied on surgeon-collected data or non- in the bilateral cohort sets a higher bar for these validated questionnaires. More investigators are patients to return to following surgery and could explain their lower than expected score when increasingly relying upon validated HRQOL instru- compared to the unilateral group. A further explana- ments to assess functional outcomes in their patients. Mid-term analysis suggests that LRP is a tion might be the rather subjective and surgeon- dependent coding of non- vs unilateral vs bilateral reliable, safe, and oncologically sound procedure cavernous nerve preservation at the time of surgery. with functional results equivalent to RRP. We have used the EPIC questionnaire to prospectively assess Nevertheless, with experience our ability to accom- plish successful NVB preservation has improved as the functional outcomes of LRP at our institution. By 72% of our last 50 patients received bilateral NVB stratifying for age and NS procedure, we can provide potent patients with further specific information preservation compared to only 47% of our first 50 regarding their potential for sexual recovery. For patients (unpublished data) (Figure 3). Similar to previous studies, our study supports example, patients who receive bilateral NS surgery are now counseled that 72% are likely to engage in the finding that younger age favors recovery of 8,15,17 successful intercourse at 12 months with or without sexual function following NS prostatectomy. Using 58 years (the mean age of our patient cohort) the use of PDEI-5. Using results from the EPIC SFSS, as a cutoff, 74% of patients under 58 years and 41% these patients may also be told that they will on average regain approximately 60% of their preo- of those over 58 years reported intercourse 1 year following NS surgery. Moreover, 82% of patients perative sexual function during the same period. In younger than 58 years who underwent bilateral NS addition, for younger patients (e.g. p58) who are potent preoperatively and receive bilateral NS surgery reported intercourse at 12 months. Mean surgery, 82% are likely to have successful inter- SFSS at 6 and 12 months favored younger patients however the difference at 12 months did not reach course at 12 months as compared to only 57% of patients older than 58 years. Using prospectively statistical significance. This lack of significance may collected, validated HRQOL instruments such as be explained by the lower baseline SFSS scores in the older compared to the younger cohort (i.e. mean EPIC, academic, and community urologists alike can baseline raw SFSS score 58 vs 68, respectively) with monitor their own outcomes, thus providing their patients with accurate and realistic expectations for the older patients therefore having a lower set point for return to baseline sexual function as compared to recovery of sexual function. the younger patients. With regards to preoperative counseling, although most patients appreciate knowing their likelihood of References intercourse and relative return to baseline function following surgery, others may want to know the 1 Roehl KA, Han M, Ramos CG, Antenor JA, Catalona WJ. odds of a complete return to ‘normal’ baseline Cancer progression and survival rates following anatomical sexual function. Using HRQOL outcomes, Hu radical retropubic prostatectomy in 3, 478 consecutive 17 patients: long-term results. J Urol 2004; 172: 910–914. et al. used a cutoff of X75% of baseline sexual 2 Han M, Partin AW, Pound CR, Epstein JI, Walsh PC. Long-term function and found that 20% of their patients biochemical disease-free and cancer-specific survival achieve baseline potency following surgery, following anatomic radical retropubic prostatectomy. The although NS status was not accounted for. Applying 15-year Johns Hopkins experience. Urol Clin North Am 2001; 28: 555–565. this same criteria to our study cohort, we found 3 Catalona WJ, Carvalhal GF, Mager DE, Smith DS. Potency, 13/27 (48%) of patients undergoing bilateral NS continence and complication rates in 1,870 consecutive returned to X75% of baseline sexual function at 12 radical retropubic prostatectomies. J Urol 1999; 162: 433–438. months following LRP. 4 Walsh PC, Marschke P, Ricker D, Burnett AL. Patient-reported urinary continence and sexual function after anatomic radical Our study is limited by the relatively small patient prostatectomy. Urology 2000; 55: 58–61. numbers and intermediate follow-up of only 1 year. 5 Talcott JA, Rieker P, Propert KJ, Clark JA, Wishnow Others have found sexual function to increase up to KI, Loughlin KR et al. Patient-reported impotence and

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