One hundred male patients who are scheduled for bilateral, nerve-sparing RARP that meet
the eligibility criteria will be enrolled. These patients will be equally randomized
(1:1) into two groups (n=50/group): one group will receive adjunctive CLARIX® CORD 1K
(Amniox Medical, Inc., Miami, FL) during RARP, while the other group will undergo RARP
without adjunctive CLARIX® CORD 1K. Subject stratification will be performed based on the
surgeon that will be performing the RARP. All patients will be given the same routine
preoperative, perioperative and postoperative evaluation and care aside from the CLARIX
CORD 1K placement in the treatment group during RARP. RARP will be performed at
Hackensack University Medical Center (30 Prospect Ave, Hackensack, NJ 07601) and follow
up visits performed at Hackensack University Medical Group Urology (360 Essex Street,
Suite 403, Hackensack, NJ 07601) or New Jersey Urology (255 W. Spring Valley Avenue Suite
101, Maywood, NJ 07607).
Two weeks prior to the RARP surgery, subjects are instructed to take low-dose oral
phosphodiesterase type 5 inhibitors (i.e. 20 mg q.d. sildenafil citrate or 5 mg q.d.
tadalafil) and perform standardized Kegel exercises (3x/day) which is our current
standard care protocol. RARP surgery will be performed at Hackensack University Medical
Center (Hackensack, NJ). The following are the key aspects of the RARP surgical technique
which will be adhered to by all surgeons: 1) dissection of the bladder neck, seminal
vesicles and vasa deferentia; 2) dissection of the neuroplexus from the posterior
Denonvilliers' fascia and lateral prostatic fascia leaving the nerves intact; 3) division
of the prostatic pedicles without cautery; 4) transection of the dorsal venous complex;
and 5) urethrovesical anastomosis. More specifically, surgical technique includes
exposing the prostate in the space of Retzius with the traditional anterior approach.
The prostatovesical tissue is dissected with monopolar electrocautery scissors with entry
into the bladder proximal to the prostatovesical junction. The bladder neck is transected
in the standard fashion followed by posterior dissection of the seminal vesicles and vasa
deferentia.
Electrocautery is kept to a minimum when dissecting the seminal vesicles to avoid damage
to the neuroplexus. (Note: each step hereafter must be performed by the PI or
Sub-investigators, e.g. not a Resident Physician). A posterior surgical plane is then
created between the rectum and prostate dorsally working from a medial to lateral
direction and maintaining at least 1 layer of Denonvilliers' fascia on the rectal wall.
The endopelvic fascia is then excised from lateral prostate and carried to capsule to
create a plane of dissection immediately alongside the prostatic capsule and keeping the
nerves attached laterally to the endopelvic fascia. Athermal division of each prostatic
pedicle will be performed. Clips or suture may be placed on each pedicle at the
discretion of the surgeon. The apex of the prostate is then dissected athermally sparing
the neuroplexus. The dorsal vein complex is proximally transected with electrocautery
while using the fourth arm to place traction on the prostate to define the space between
the dorsal vein complex and the apex of the prostate. Apically, the prostate is divided
from the urethra (paying special attention to the sphincter muscle and posterior lateral
nerve bundle on each side) allowing the prostate to be removed. Once free, the prostate
is placed in a collection bag and a drain is used for a certain period at the discretion
of the surgeon.
Surgical site bleeding is managed using standard surgical techniques with sutures or
cellulose polymer. If the patient is randomized to the treatment group, CLARIX CORD 1K is
placed flat over the neuroplexis at the 5 and 7 clock position where the largest
concentration of nerves exist. Sutures may be used to secure the CLARIX in place if
necessary and cellulose polymer (Surgicel, Ethicon, Somerville, NJ) can be placed over
the CLARIX CORD at the discretion of the physician.
At this point the bladder neck will be reconstructed as necessary to maintain a lumen of
approximately 30 french. The vesicourethral anastomosis is performed using a V-lock
barbed suture. The anastomosis will be tested by filling bladder to confirm the absence
of leakage. If indicated, a bilateral pelvic lymph node dissection is performed (with
clips at the discretion of the physician) using standard (borders along the external
iliac artery and vein, obturator fossa, obturator nerve and pubic bone) or extended
(borders additionally include internal iliac artery) technique at the discretion of the
physician. Bleeding will be adequately managed. Postoperatively, all subjects are
instructed to take low-dose oral phosphodiesterase type 5 inhibitors (i.e. 20 mg q.d.
sildenafil citrate or 5 mg q.d. tadalafil) and perform standardized Kegel exercises
(3x/day) following urethral catheter removal. When patients are sexually active, they may
increase to full dosage of oral phosphodiesterase type 5 inhibitors up to twice a week.
At 3 months after RARP, and if patients have severe or worse incontinence (defined as
ICIQ score of >12) and desire additional treatment for urinary incontinence,[42] they
will undergo pelvic floor therapy. Subjects will return for follow up visits at 6 weeks
(±1 week), 3 months (±2 weeks), 6 months (±3 weeks) and 12 months (±4 weeks) when data
will be collected.
Patient reported outcomes will be assessed including continence, potency, and
satisfaction. Occurrence of adverse events, number of readmissions, and need for
reintervention will also be recorded. Measurement of serum PSA levels will also be
performed.