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European UrologyVolume 61, issue 5, pages e41-e52, May 2012
Open Radical Retropubic Prostatectomy Using High Anterior Release of the Levator Fascia and Constant Haptic Feedback in Bilateral Neurovascular Bundle Preservation Plus Early Postoperative Phosphodiesterase Type 5 Inhibition: A Contemporary Series
Accepted 24 November 2011, Published online 6 December 2011, pages 878 - 884
Patients with newly diagnosed localized prostate cancer who choose surgery want cure and decent quality of life, namely, pad-free urinary control and, often, erectile function satisfactory for sexual intercourse.
Determine in a prospective study the positive surgical margin rate and functional outcomes for a consecutive series of patients undergoing open radical retropubic prostatectomy (ORRP) with bilateral neurovascular bundle preservation (BNVBP) performed by one experienced surgeon.
Design, setting, and participants
Of 197 consecutive patients undergoing BNVBP during 2008, 123 were evaluable, allowing both immediate postoperative phosphodiesterase type 5 inhibition (PDE5i) and a third-party questionnaire with validated urinary and erectile function domains provided preoperatively and at 3, 6, and 12 mo postoperatively.
Two interventions were used: (1) ORRP with ×4.3 optical loupes and constant digital tactile monitoring during BNVBP preceded by high anterior release (HAR) of levator fascia and neurovascular bundles and (2) early postoperative PDE5i.
Age; biopsy Gleason score; clinical stage; preoperative prostate-specific antigen level; pathologic grade; stage; margin status; University of California, Los Angeles Prostate Cancer Index domain for urinary pad use and bother; and International Index of Erectile Function-5 (IIEF-5) were used.
Results and limitations
Surgical margins were positive in 1 of the 123 evaluable patients (1%). At 1 yr, 95% of patients were pad-free. Satisfactory erectile function was achieved by 109 patients (89%): 82 (67%) scored an IIEF-5 of 22–25, and 27 (22%) scored <22–25 with ≥4 on either satisfaction or confidence questions or achieved “full” erection within the first year. Mean hospital stay was 1.3 d. Limitations were (1) observational, noncomparative, single-surgeon series and (2) in third-party methodology, failure to capture patient answers for all questionnaire intervals with resultant inability to address durability of functional results for all patients.
ORRP using ×4.3 optical loupe magnification, constant haptic feedback in BNVBP with HAR, and immediate postoperative PDE5i yielded satisfactory outcomes.
During the past decade in the United States, open radical retropubic prostatectomy (ORRP) has been progressively supplanted by robotic-assisted radical prostatectomy (RARP). ORRP has been notoriously difficult for many surgeons, because access to the prostate seems relatively limited, especially for patients who are obese or have a narrow or deep pelvis. In such cases, dorsal venous complex (DVC) control becomes a formidable venture. Furthermore, prostate removal has often been conducted without the aid of any visual magnification or sufficient lighting, both complicating and obfuscating accurate dissection.
With the above in mind, in December 2007 we designed a prospective study of contemporary ORRP to determine whether we could achieve respectable functional outcomes as well as a low rate of positive surgical margins (PSMs)  using ×4.3 surgical loupe magnification to perform bilateral neurovascular bundle preservation (BNVBP), preceded by newly introduced high anterior release (HAR) of the levator fascia and neurovascular bundles (NVBs)  and , and, postoperatively, early phosphodiesterase type 5 (PDE5) inhibition (PDE5i).
With the approval of the Mayo Clinic institutional review board, we reviewed for the year 2008 all prospectively collected data for 197 consecutive patients with intention to treat by ORRP with HAR and BNVBP. Of the 197 patients, 22 (11%) with 4 PSMs underwent subtotal NVB preservation unilaterally (n = 13) or bilaterally (n = 9) on the basis of intraoperative haptic feedback. Of the 175 patients remaining, 52 (1 PSM) were ineligible: 24 refused our study; 16 were impotent preoperatively, with 15 of those patients having a mean International Index of Erectile Function-5 (IIEF-5) score of 3.2 (range: 1–12) and 1 having a missing preoperative IIEF-5 score; 5 without a partner had no interest in PDE5i and had preoperative IIEF-5 scores of 10, 15, 16, 16, and 18, respectively; 2 had no partner, no confidence, no intercourse, with (1) or without (1) PDE5i; 2 had questionnaires that were incomplete or uninterpretable; 1 had a partner, preoperative erectile dysfunction according to his record, but the IIEF-5 score was missing; 1, with a positive lymph node, received androgen deprivation postoperatively; and 1 was lost to follow-up. Thus, 123 patients (mean age, 58 yr of age; range: 41–76) of 175 (70%), beyond surgery, had to agree to early postoperative PDE5i and respond to a third-party questionnaire to be evaluable.
These 123 patients—otherwise healthy and nonobese after diet and exercise when needed—underwent ORRP for organ-confined, localized prostate cancer with HAR followed by BNVBP. All procedures were performed by an experienced single surgeon (R.P.M.) using ×4.3 optical loupes. In addition to promoting return of satisfactory erectile function, BNVBP was routinely attempted in appropriate patients based on evidence that it may enhance postoperative urinary control  and .
2.1. Surgical technique
Preemptive analgesia , beginning with preoperative medication, was used to permit relatively early hospital discharge. Patients were anesthetized and placed in a supine position, with slight flexion and minimal need for Trendelenburg positioning. The lower midline abdominal incision extended from the top of the pubis, ending with a one-quarter skirt to the left or right of the umbilicus (Fig. 1) . This added extension allowed ambidextrous dissection and both prostate manipulation and stabilization without tension on the NVBs.
DVC control was accomplished with a modified Babcock forceps  and  and subsequent placement of distal and proximal polyglactin sutures to maintain midline DVC compression sufficiently proximal to allow HAR. After ligation and division of the DVC , bleeding was controlled with 5-0 poliglecaprone suture or stainless steel clips (3–10 mm) to minimize trauma to adjacent nerve fibers. For HAR, high initial, lateral fascial release was instituted  and  to expedite identification and mobilization of the NVBs, starting along their most anterior aspect.
Before urethral transection, full-length membranous urethral and striated sphincter preservation was accomplished using a vein retractor to retract anterior prostate overlap of the urethra (Fig. 2). Use of a No. 9 Gil-Vernet retractor allowed posterior urethral transection just distal to the visible verumontanum (seminal colliculus) without entering the prostate (Fig. 3).
For efficient dissection and optimal haptic feedback in BNVBP, the technique was ambidextrous, that is, with a hand gently holding the prostate, the left index finger was placed along the right posterolateral prostate, while the right hand with the instrument released the right NVB. In contrast, the right index finger was placed along the left posterolateral prostate, while the left hand with the instrument released the left NVB (Fig. 4). No cautery was used to dissect the apex of the prostate or the NVBs or for division anterior of the vascular pedicle to the prostate. The remaining steps, including four-simple-suture vesicourethral anastomosis, have been described in detail . Surgical skin closure was performed to provide acceptable cosmesis (Fig. 5). The 18F all-silicone Foley urethral catheter was left indwelling for 18–21 d to allow complete collagenization at the anastomosis and to avoid cystography.
2.2. Pathologic evaluation
By strict protocol, all prostates were India-inked, transversely sectioned in 3-mm intervals, and examined by frozen section before wound closure, and then subsequently by permanent section for the presence of PSMs. Each transverse section was divided into quadrants, providing left and right, anterior and posterior specimens for histologic evaluation. Apical quadrants were sectioned vertically.
2.3. Functional outcome evaluation
Functional results were obtained with a non-clinician–disseminated and result-recorded third-party questionnaire that included both the University of California, Los Angeles Prostate Cancer Index (UCLA-PCI) urinary domain and the IIEF-5. These questionnaires were provided preoperatively and sent for completion and mail-in at 3, 6, and 12 mo postoperatively. Patients were also asked whether they had a partner; which PDE5 inhibitor they were using; and whether erections were full, partial, or absent.
Begun during the week after surgery, postoperative PDE5i therapy for erectile function was defined as immediate daily tadalafil 10 mg or, if not tolerated, sildenafil 25 mg before sleep every night to promote nocturnal penile tumescence. On catheter removal, patients were prescribed the option of added vardenafil 20 mg or sildenafil up to 100 mg twice weekly 4 d apart to initiate sexual activity. Satisfactory postoperative erectile function was defined as achieving an IIEF-5 score of 22–25  or an IIEF-5 score <22–25 and either a score ≥4 on questions about satisfactory intercourse or confidence that an erection could be attained and maintained, or—barring the above—a full erection. Use of intracavernosal injection or a vacuum erection device was considered a failure.
Preoperative variables are provided in Table 1, postoperative variables in Table 2, and postoperative pathologic characteristics in Table 3. For assessing functional outcomes with the UCLA-PCI urinary domain and the IIEF-5, and given the limitation that we could not obtain patient questionnaire cooperation and submission for each time interval, the best scores or responses at 3, 6, or 12 mo were selected for each of the 123 evaluable patients.
|Mean age, yr (range)||57 (41–73)|
|Mean PSA, ng/ml (range)||4.9 (0.4–21)|
|Biopsy Gleason score, no. of patients (%):|
|Clinical stage, no. of patients (%):|
PSA = prostate-specific antigen.
|Operative time, min||267 (199–370)a|
|EBL, ml||489 (50–1500)b|
|Hospital stay, d||1.3 (1–3)|
a Includes resident doing incision, bilateral PLND, and wound closure.
b In 20 patients (16%), transfusion with a mean of 2.25 U (range: 1–4).
EBL = estimated blood loss.
|Stage||Gleason score||No. of patients|
a One patient with a positive surgical margin of 1 mm at the left anterior apex.
Urinary control was satisfactory, with 95% of patients using no pads per day by 1 yr (Table 4). By nonclinician telephone call, very small or small problems were determined to be predominantly stress related and, in one patient, urgency related (rare). Only one patient who used two pads per day had a moderate problem that resulted from overactive bladder (OAB) with resultant urge incontinence; at 1 yr, he could control his OAB by avoiding coffee and chocolate.
|Pads per day||Urinary function problem||No. of patients (%)|
|0||Very small||14 (11)|
|1||Very small||1 (1)|
Of 82 patients (67%) who had an IIEF-5 score of 22–25 (Table 5 and Table 6), 28 (34%) had this score at 3 mo, 21 (26%) at 6 mo, and 33 (40%) at 1 yr. The breakdown of their scores was as follows: a 22 for 7 patients (8%), a 23 for 12 patients (15%), a 24 for 23 patients (28%), and a 25 for 40 patients (49%). Of these 82 patients, 10 (12%) reported no need to continue PDE5i, because they found they could function without it—5 from time of catheter removal and 5 after variable periods receiving PDE5i.
|Erectile function by IIEF-5 score||No. of patients (%)|
|<22–25, ≥4 satisfaction||18 (15)|
|<22–25, ≥4 confidence||7 (6)|
|<22–25, “full” erection||2 (1)|
IIEF-5 = International Index of Erectile Function-5.
|Age range, yr||Satisfactory erectile function|
|IIEF-5 score of 22–25 (n = 82)
No. of patients (%)
|IIEF score of 22–25 plusa (n = 109)
No. of patients (%)
|40–49||14 of 15 (93)||15 of 15 (100)|
|50–59||35 of 51 (69)||48 of 51 (94)|
|60–69||30 of 49 (61)||42 of 49 (86)|
|≥70||3 of 8 (38)||4 of 8 (50)|
a Patients with an IIEF score of 22–25 plus those with an IIEF score <22–25 with a score ≥4 on questions about satisfactory intercourse or confidence that erection could be attained and maintained or full erection.
IIEF-5 = International Index of Erectile Function-5.
By adding (Table 5 and Table 6) patients with an IIEF-5 score of 22–25 to those with IIEF-5 score <22–25 and a score ≥4 on questions about satisfactory intercourse or confidence that an erection could be attained and maintained or a full erection, successful erectile function was experienced by 109 of 123 patients (89%) at a mean age of 57 yr of age (range: 41–73). The mean age of the 14 patients who failed was 64 yr of age (range: 58–76). Eleven of them achieved full erection with injection or vacuum erection device with or without PDE5i; five had an IIEF-5 score of 22–25 with injection. Of the 27 patients (22%) who had an IIEF-5 score <22–25 and a score ≥4 on the confidence or satisfaction questions, 22 had a median IIEF-5 score of 19, and 5 not having intercourse had a median IIEF-5 score of 4 but ≥4 on confidence.
The regimens that the 109 patients were taking for satisfactory erectile function were tracked according to whether full or partial erections were achieved. Tadalafil 10 mg before sleep was sufficient for 47 of the 123 patients (38%; 45 full; 1 partial with an IIEF-5 score of 24; 1 not specified). Tadalafil supplemented with vardenafil or sildenafil was used by 41 patients (33%; 31 full; 6 partial; 4 not specified). Vardenafil or sildenafil was used alone by 11 patients (9%; all full). No PDE5i was needed by 10 patients (8%; none specifying full or partial). Of seven patients who had partial designations, one had an IIEF-5 score of 24, and the remaining six had a median IIEF-5 score of 17.5, with a score ≥4 on the confidence or satisfaction questions. Of the 15 patients who did not specify full or partial erection, 13 had an IIEF-5 score of 22–25, and 2 had an IIEF-5 score of 19.
Given a mean follow-up of 1.9 yr (range:0.1–3.1), postoperative follow-up with respect to biochemical recurrence–free survival or other oncologic end points was premature. On review of electronic records, 14 patients experienced 15 complications (Table 7 with Clavien classification ). There were no vesical neck contractures.
|Complication||Clavien classification||Management||No. (%)|
|Lymphocele (2 infected)||3a||Percutaneous aspiration, drain placement||4 (3)|
|DVT, PE||2||Anticoagulation||2 (2)|
|Early wound infection||2||Antibiotics||1 (1)|
|Ileus||2||Nasogastric tube insertion||1 (1)|
|Early urinary retention||1||Catheter insertion||1 (1)|
|Adverse drug reaction||1||Observation||5a (4)|
a 3 tadalafil; 2 antibiotic.
DVT = deep vein thrombosis; PE = pulmonary embolus.
Although patient preferences vary , patients undergoing radical prostatectomy by any technique want to be cured and have excellent quality of life outcomes  and . We report results emphasizing the ×4.3 magnification, ambidextrous, constant digital haptic–feedback technique in ORRP for BNVBP beginning with HAR after careful DVC control. Our technique allowed improved anatomic dissection both at the apex and laterally. In the process, we obtained a single-digit rate of PSMs (1%) and maximized membranous urethral length  and  for urinary control. Although the value and timing of postoperative PDE5i is indeed controversial, notable successful early PDE5i has been reported since our study's inception .
Advantages of the ORRP incision used included (1) access into difficult pelvises such as the android subtype, (2) easier extended pelvic lymph node dissection, (3) space sufficient for DVC control that allows an assistant to see and help with hemostasis by providing suction through two devices (Fig. 2), (4) stabilization of the prostate with either the right or the left hand depending on side of NVB release, (5) space for both retrograde and antegrade dissection, and (6) no substantial cosmetic disfigurement or disruption of the umbilicus.
The incision had to be the length illustrated in Fig. 1 to accommodate the position of the hand, as shown in Fig. 4. Surgeons with large hands will have difficulty with the technique as illustrated and should consider techniques that are more instrument dependent. What is shown is entirely adequate for a hand-glove size of 7.5–8.0.
For BNVBP, we added HAR, because it may result in improved potency in men undergoing ORRP  and . Recent mapping of the anterior component of the NVBs makes HAR a natural technical consequence of the anatomic findings . The relevant cavernous nerve distribution and preservation should be posterolaterally, laterally, and anteriorly as high as possible. Furthermore, we evaluated our penile rehabilitation program and captured patients who were not having intercourse for personal reasons but who, on the basis of their answers to the questionnaire, seemed to be perfectly capable given the right opportunity.
Concern about excessive levels of PDE5i being administered might be raised, but we saw no downside in what was prescribed. Three patients stopped tadalafil use because of drug reaction (Table 7). A 6-mo daily regimen of tadalafil 10 or 20 mg produced some minor but no serious adverse effects .
Study limitations include insufficient data to support the durability of optimal response within or beyond the first year. We could not motivate patients to answer questionnaires by mail-in for every study interval; therefore, we chose to report the best IIEF-5 score during that first year as the simplest method to determine whether successful postoperative erectile function had occurred. Our report is an observational, noncomparative, prospective study of a single surgeon's results.
If open surgeons are helped by the technical aspects we share and can reproduce the results reported herein, they need not be deterred by the sweeping popularity of RARP.
We have sought to show progress in ORRP, emphasizing optical loupe magnification at ×4.3 and relatively inexpensive illumination with the ability to report three outcomes: PSMs, urinary control, and erectile function in the same group of patients. The technique as described and illustrated minimized PSMs during delicate BNVBP with HAR. Satisfactory functional outcomes were achieved. Hospital stay was short, and complications were not more than expected.
Author contributions: Robert P. Myers had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Umbreit, Myers.
Acquisition of data: Hubanks.
Analysis and interpretation of data: Hubanks, Umbreit, Karnes, Myers.
Drafting of the manuscript: Myers.
Critical revision of the manuscript for important intellectual content: Umbreit, Karnes, Myers.
Statistical analysis: Myers.
Obtaining funding: None.
Administrative, technical, or material support: None.
Supervision: Karnes, Myers.
Other (specify): None.
Financial disclosures: I certify that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: None.
Funding/Support and role of the sponsor: None.
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Department of Urology, Mayo Clinic, Rochester, MN, USA
© 2011 European Association of Urology, Published by Elsevier B.V.
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