EURURO Vol. 72 No. 5

Introduction

Prostate cancer continues to be the most common solid

organ malignancy in men in developed world

[1]

. The

incidence is expected to rise as the population ages and

longevity increases. Radical prostatectomy (RP) is arguably

the most common treatment offered in those eligible for it.

The goal of an RP is to achieve complete cancer control

while preserving urinary and sexual faculties.

Studies of open RP have suggested urinary continence

following surgery to be one of the most important

indicators of quality of life and treatment satisfaction

[2,3] .

Analyses of Medicare data have shown that at 1 yr

after open surgery, approximately 30% of men continue to

experience urinary incontinence (including those operated

by high-volume surgeons)

[4]

or are bothered by it

[5]

. The

highest rates of urinary incontinence and associated bother

are noted in the first 2–6 mo after surgery

[3,6,7]

. More

recently, increasing utilization and surgeon experience

with the robotic platform have improved urinary conti-

nence rates to 70–95% at 12 mo

[8] .

However, lack of

urinary continence in the select few and the time to

continence continue to be issues of significant bother even

among men undergoing robot-assisted radical prostatec-

tomy (RARP)

[5]

In this context, Galfano and colleagues

[9,10]

have

recently described their technique of a Retzius-sparing

approach of RARP (posterior RARP), noting urinary conti-

nence (measured as 0 pads/one safety liner per day) rate of

90% at 1 wk after catheter removal. In a pilot study of

81 patients, we noted a 78% continence rate at 1 wk after

catheter removal in patients who underwent the Retzius-

sparing approach, compared with 50% in those who

underwent the traditional RARP. Encouraged by these

findings, we sought to compare the efficacy of conventional

(anterior) approach for RARP

[11,12]

with that of the

posterior approach for RARP on short-term, patient-

reported urinary continence, in the setting of a randomized

controlled trial (RCT). We hypothesized that patients

undergoing posterior RARP will have faster recovery of

urinary continence, along with favorable urinary bother

outcomes. While this paper focuses on urinary continence,

overall urinary function, and urinary bother, the accompa-

nying paper details other secondary outcomes, including

sexual function, perioperative morbidity, and short-term

oncological outcomes.

Patients and methods

We conducted a two-group, parallel-design, pragmatic trial of 120 con-

secutive patients aged 40–75 yr with low–intermediate-risk prostate

cancer (according to the National Comprehensive Cancer Network

[NCCN]) undergoing primary RARP by a single surgical team (M.M./W.J.)

at a tertiary care institution (Vattikuti Urology Institute) (see

Fig. 1

and

Supplementary material for details). Men with a high risk of NCCN, cN1

or M1 prostate cancer, or pre-existing urinary incontinence were

excluded. The study was approved by the Henry Ford Hospital

Institutional Review Board (IRB# 9220) and was registered on

ClinicalTrials.gov (NCT02352103).

Based on the observed treatment effect of a 30% higher urinary

continence rate in the posterior versus anterior approach 1 wk after

catheter removal, power set at 0.9, alpha level at 0.05, and correction for

15% nonresponse rate, the optimal sample size for this study was

calculated to be 120 patients (60 patients in each arm). Participants were

randomly assigned using a simple randomization procedure (comput-

erized random numbers generated using Microsoft Excel for Mac

2011 version 14.6.4) to one of the two treatment groups (1:1 allocation).

Treatment allocation was concealed from the operating team; however,

operative details were documented in the electronic medical record as

required by institutional regulations (Supplementary material). The

details of surgical technique, nerve sparing, and postoperative rehabili-

tation pathway for anterior RARP have been described previously

[11– 13] ;

key steps of the posterior RARP approach were similar to those

described by Galfano et al

[9,10]

and have been detailed in the

accompanying Supplementary material and surgical video. Of note, our

technique of posterior RARP differed slightly from the approach of

Galfano et al in that the port placements were similar to those of anterior

approach, seminal vesicle suspension was not performed, and a

suprapubic tube was placed routinely for bladder drainage prior to

port placements.

2.1.

Outcome assessment

We followed the CONSORT-PRO guidelines for patient-reported out-

comes

[14] .

All patients were given scales to measure pad weight (Fit and Fresh

Scale; MEDport, LLC, Providence, RI, USA

[15]

) and a log sheet to

document them, beginning the day following suprapubic catheter

removal. The primary outcome of the study was urinary continence

recovery within 1 wk of catheter removal, defined as patient-reported

use of 0 pads or one security liner per day. Secondary outcomes reported

in this paper are 3-mo urinary continence recovery, postoperative

urinary function (measured by the International

[12_TD$DIFF]

Prostate Symptom

Score [IPSS]) and urinary function-related bother (measured by the IPSS

quality of life question with a response from 0 to 6), perioperative

complications, and 1-yr oncological outcomes. Urinary outcomes (ie, pad

use and IPSS) were assessed at 1 and 2 wk, and 1 and 3 mo, with all

of postoperative complications (12% anterior vs 18% posterior) and probability of BCRFS

(0.91 vs 0.91) were comparable in the two arms.

Conclusions:

In this single-center randomized study, the Retzius-sparing approach of RARP

resulted in earlier recovery of UC and lower UF-related bother compared with standard

RARP. These results require long-term validation and reproduction by other centers, as well

as studies on men with high-risk localized disease.

Patient summary:

In our hands, men with low–intermediate-risk prostate cancer under-

going Retzius-sparing robot-assisted radical prostatectomy (RARP) had earlier recovery of

urinary continence and lower urinary function-related bother than those undergoing

standard RARP.

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