Novel Use of the Capio Urethral Anastomotic Suturing Device: A 50-Case Assessment

Abstract

Objective

Robotic laparoscopic assisted prostatectomy (RALP) has become the predominant technique for prostatectomy despite significant expense and no robust evidence supporting better cancer control, erectile function, or continence. Several studies have demonstrated lower bladder neck contracture (BNC) rates with RALP, believed to be related to improved visualization and control of the urethrovesical anastomosis. We evaluated the Capio™ radical prostatectomy (RP) suture capturing device for improving anastomotic precision during urethrovesical anastomosis in open radical prostatectomy.

Materials and Methods

We performed a retrospective review on a single-surgeon series of 50 consecutive patients undergoing radical retropubic prostatectomy (RRP) with utilization of the Capio™ RP device at an academic hospital (February 2010 to May 2012). Patient demographics, pathology, and outcomes data including rates of anastomotic leak, BNC, erectile function, and continence were collected.

Results

Mean age of patients at the time of procedure was 60.4 ± 6.43 years. Patients were stratifed by D'Amico criteria into low (14.3%), intermediate (67.4%), and high (18.4%) risk groups. Mean follow-up for all patients was 13.1 ± 7.29 months. No patients were diagnosed with BNC within 90 days after surgery. Two patients (4%) were subsequently diagnosed and treated for BNC, one of whom was asymptomatic prior to diagnosis.

Conclusion

Utilizing the Capio™ RP device during RRP, we were able to achieve a BNC rate equivalent to rates reported for RALP. Use of the Capio™ RP device appears to be a cost-effective method for improving RRP urethrovesical anastomotic results.

Introduction

Demand for minimally invasive radical prostatectomy (RP), particularly robot-assisted laparoscopic prostatectomy (RALP) has increased dramatically over the past decade. This increase has sparked controversy because, despite significant cost increases, at best only modest improvement in outcomes has been demonstrated for the robotic procedure. One touted advantage of RALP compared to radical retropubic prostatectomy (RRP) is a lower bladder neck contracture (BNC) rate [1]. BNC rates with RRP are generally 2.6-12% [2,3,4,5,6], though some series have reported BNC incidence as low as 0.5% and as high as 33% [7,8]. BNC rates with laparoscopic and robotic prostatectomy are generally lower, at 1.3-6.3% [5,6]. It has been proposed that the lower BNC rate with RALP may be due to improved suturing precision and control, in addition to the surgeon having a magnified cal anastomosis (UVA) [5]. BNCs become clinically significant because they often require secondary procedures to manage the stricture, after which patients commonly experience higher incontinence rates [9].

A recent modification to the standard RRP procedure is the use of the Capio™ RP suture-capturing device (Boston Scientific, Natick, MA) for placement of the UVA sutures. The device is designed to throw, catch, and retrieve sutures in one step, eliminating the need for placement of free-hand sutures. The device also facilitates suture placement by rotating in 30° increments to 120° clockwise and 180° counter-clockwise. The Capio™ RP device is ideal for the deep, difficult-to-access urethral stump [10]. It is particularly useful in the current training era where RRP volume is diminished and mastering a free-hand UVA difficult. The suture has a sharp bulleted distal end, which the Capio™ RP device passes through the urethral stump, as well as a needle attached to the proximal end for free-hand suture placement through the bladder neck.

With better control and easier placement of anastomotic sutures, we hypothesized that rates of BNC after RRP utilizing the Capio™ RP device would be lower than previously reported, potentially comparable to contemporary RALP results. We therefore reviewed a sequential 50 case single-surgeon, single-institution series to determine the incidence of BNC. We further compare our results to published BNC rates for both RRP without use of the Capio™ device and RALP.

Patients and Methods

Upon Institutional Review Board approval, medical records from 50 consecutive RRPs utilizing the Capio™ RP device for creation of the U VA were analyzed retrospectively. A single surgeon (J.A.B.) performed all procedures with the assistance of resident physician surgeons at the University of Iowa. Resident physicians were routinely actively involved in the performance of the UVA.

Patient demographic data, pathology, continence rates, and postoperative complications were recorded. Continence was quantified by patient-reported daily pad use with complete continence defined as “no pads per day”. Postoperative complications included anastomotic leak rates at discharge and within 90 days, BNC within 90 days, and BNC requiring secondary treatment. BNC was diagnosed by flexible cystoscopy in clinically symptomatic patients. Postoperative BNC rates were reported and compared to previously published BNC rates in RALP and RRP performed without use of the Capio™ RP device.

The Capio™ RP device was used to place urethral anastomotic sutures in the urethral stump after dorsal vein ligation and anterior urethral transection but prior to removal of the prostate. The urethra is divided anteriorly as well as laterally, approximately 2 mm from the prostate, leaving the posterior urethra intact. The Foley catheter balloon is then deflated and the catheter used as a marker for the urethral opening. The Capio™ RP device is then positioned in the urethral stump and sutures are placed sequentially at the 12, 2, 4, 10, 8 and 6 O'clock positions sequentially by rotating the active component of the device clockwise or counterclockwise. The posterior urethra is then divided and the prostate removed in a bladder neck-sparing fashion. Two additional 2-0 or 3-0 monocryl free-hand sutures may be placed if necessary at the 5 and 7 O'clock positions if the bladder neck is capacious. The Capio™ RP sutures are then placed through the bladder neck at the posterior 6, 8, and 4 O'clock positions, after which the Foley catheter is advanced into the bladder. The anterior 2, 12, and 10 O'clock sutures are then placed and the sutures ligated.

Results

Fifty men underwent RRP using the Capio™ RP device between February 2010 and May 2012 (table 1). Mean age of patients at the time of procedure was 50.4 ± 6.43 years. Patients were stratified by D'Amico criteria into low (14.3%), intermediate (67.4%), and high (18.4%) risk groups. All patients were continent at the time of surgery, defined as no pads per day. Mean preoperative prostate specific antigen (PSA) was 7.4 ± 5.28 mg/l. PSA became undetectable for all but 4 patients (8%) postoperatively. The mean PSA if detectable following surgery was 0.16 mg/l. Median preoperative and postoperative Gleason score was 7 with a range of 6-10. Mean follow-up for all patients was 13.1 ± 7.29 months. Forty-seven patients (94%) had follow-up data available for longer than 90 days postoperatively.

Table 1.

Data on all patients treated with RRP using Capio^TM device

Item	Value
Number of patients	50
Mean ± SD
Age, years	60.4 ± 6.43
BMI	28.5 ± 4.07
Preoperative PSA level, mg/l	7.4 ± 5.28
Postoperative PSA level, mg/l	0.16
Median (range)
Preoperative Gleason score	7.0 (6.0–10.0)
Postoperative Gleason score	7.0 (6.0–10.0)
Number (%)
Clinical stage
T1	40 (80)
T2	7 (14)
T3	3 (6)
D'Amico risk
Low	7 (14.3)
Intermediate	33 (67.4)
High	9 (18.4)

No patients were diagnosed with a BNC within 90 days after surgery (table 2). Two patients (4%) were subsequently diagnosed and treated for BNC. One patient was diagnosed 7.6 months postoperatively after complaints of decreased urinary stream and frequency. A BNC was diagnosed by flexible cystoscopy and managed endoscopically with balloon dilation, after which his symptoms improved. He has not required further treatment to date. A second patient in the series was diagnosed with a BNC at 18.2 months postoperatively after being admitted to the ICU for management of pneumonia. The BNC was asymptomatic prior to admission and was diagnosed by flexible cystoscopy following an inability to pass a Foley into the bladder.

Table 2.

Complications following RRP using Capio^TM device

Complications	n
Anastomotic leak at discharge	2 (4%)
Anastomotic leak within 90 days postoperatively	0
BNC within 90 days postoperatively	0
BNC requiring treatment	2 (4%)
Rectourethral fistula	0

Ten incontinent patients (20%) were lost to follow-up or transitioned to local care before 12 months, 7 before and 3 after 6 months follow-up. Thirty-three (82.5%) of the remaining 40 patients had documented pad-free continence (15 by 6 months, 15 by 6-12 months and 3 after 12 months follow-up) (table 3). Of the 7 (17.5%) patients with documented incontinence after 12 months of follow-up, 4 (10%) required only a “safety pad” and 3 (8%) require 1-2 pads per day. Both patients treated for BNC in this series achieved continence within 12 months of surgery and had no incontinence following treatment.

Table 3.

Continence rates following RRP using Capio^TM device

Continence status	n
Incontinent postoperatively (months)	10
< 6	7
6–12	3
Pad-free continence documented postoperatively (months)	33
< 6	15
6–12	15
> 12	3

Discussion

The use of robot-assisted laparoscopic radical prostatectomy has been rapidly adopted over the past decade [11]. In addition to lower BNC rates, reported advantages of RALP, compared to RRP, include decreased blood loss, transfusions, and length of hospital stay [1]. However, controversy remains about the relevance of these results and the overall benefit in surgical outcomes.

The cause of BNC following prostatectomy has not been precisely elucidated and is likely multifactorial. The technical factors typically associated with BNC development include low surgeon volume, poor mucosal apposition, urinary extravasation, and excessive narrowing of the urethral anastomosis [5]. Several authors have proposed that RALP provides technical advantages given better visualization and improved instrument maneuverability [12].

In this present series of 50 consecutive RRPs using the Capio™ RP device, only 2 (4%) patients were treated for a BNC, which is on the lower end of commonly quoted BNC rates following RRP of 2.6-12%. Additionally, 1 patient diagnosed with a BNC had no urinary symptoms and underwent dilation after unsuccessful Foley catheter placement during treatment of a co-morbid condition. Discounting this patient, the clinically symptomatic BNC rate in our series is 2%, lower than any published RRP BNC rate and consistent with RALP BNC rates of 1.3-6.3%.

Creation of the UVA is one of the more technically demanding aspects of a prostatectomy, open or robotic, due to the difficulty of accurately approximating the mucosal surfaces necessary for a successful anastomosis. If a gap remains, there is an increased chance of scarring and BNC development [13]. As a result, it has been demonstrated that experienced and high-volume surgeons have significantly lower BNC rates [4]. It should be emphasized that in this series the resident physician routinely operated the Capio™ RP device placing and then ligating the anastomotic sutures. This is significant because despite their limited RRP experience, the simplicity and precision afforded by the Capio™ RP device was able to facilitate BNC rates that are both lower than previously reported by high-volume open RRP surgeons and comparable to contemporary RALP series.

While debate remains regarding oncological and overall surgical outcomes benefit of RALP, the significantly higher cost of RALP is largely undisputed. The overall cost per case of RALP has been estimated to exceed the cost per case of RRP by $5,300 USD [14]. The cost of the Capio™ RP suturing device is $487.50 USD ($315.00 for the device plus 6 sutures priced at $28.75 each). Thus, the Capio™ RP device is substantially less than equipment costs for RALP, making it a cost-effective means to improve prostatectomy outcomes.

Conclusion

One of the few documented benefits of RALP over RRP is a lower BNC rate. By using the Capio™ RP device, we were able to obtain BNC rates (4% total, 2% symptomatic), in a training environment, equivalent to those reported for RALP. Therefore, use of the Capio™ RP device appears to be a cost-effective method for improving RP anastomotic results.