Patients and the ProPep AdvantageThe ProPep® Nerve Monitoring System is the first FDA-cleared real-time nerve monitoring system for laparoscopic & robotic prostatectomy surgery. This system helps surgeons identify critical non-visible somatic nerves at risk during surgery, thereby allowing a surgeon to make more-informed decisions on how to spare these nerves, potentially minimizing nerve damage contributing to incontinence and sexual dysfunction.
The Results
Previous published Patient reported outcomes trials document time to recovery of urinary function can take take 1 to 2 years for a patient to return to baseline after RARP1. Using the ProPep® Nerve Monitoring System intraoperatively, clinical trial results show that ProPep Patients return to continence much sooner.
*Data on file.
Study Background:
A single highly experienced surgeon, prospective cohort study was performed at Indiana University for patients undergoing robotic assisted radical prostatectomy from 2015-2017. These patients were aligned 1:2 with contemporary controls from the same surgeon on age (within 5 years), biopsy Gleason score, and nerve-sparing status.
ProPep Study Parameters:
Control Group = 138 men
ProPep Patients = 69 men
The UK ProtecT Trial Parameters:
To provide comparison to the ProPep Study, we also provide pad usage data from the UK ProtecT Trial. This 6-year, 1643 patient study was published in the New England Journal of Medicine in September 2016. No data earlier than 6 months, post surgery is available.
*Data on file.
Expanded Prostate Cancer Index composite (EPIC): A one page, patient-reported questionnaire consisting of 16 questions that allow the clinician to evaluate a patient. Six questions relate to the area of Sexual Function.
The EPIC Sexual Function Averages that compare ProPep Patients and the Control data have been adjusted for patient age or co-morbities factors that might impact sexual function.
The UK ProtecT Trial Parameters: 6-year, 1643 patient study published in the New England Journal of Medicine in September 2016. No data earlier than 6 months post surgery is available.
Those That Lie Outside the NVB
Nerve sparing during radical prostatectomy has traditionally focused on preservation of the parasympathetic nerves located within the NVB that are responsible for the vascular/filling phase of the erectile response. Studies have shown, however, that a somatic nerve (the muscular branch of the perineal nerve) not located within the NVB and found in variable locations around the apex of the prostate, drives the muscular phase of the erectile response. This nerve is responsible for the achievement of the full tumescence and rigidity needed for penetration.
Using the ProPep® Nerve Monitoring Device, surgeons have demonstrated the ability to accurately, safely, and efficiently identify non-visible critical nerves during RARP. The variability in the location of critical somatic nerves, the resultant inability to predict their location based on anatomic landmarks, and the fact that they are located outside of the traditional NVB can make the use of the ProPep® Nerve Monitoring Device essential in locating these nerves to avoid potentially damaging them during posterior pedicle and apical dissection.
You Can’t Spare What You Can’t See
The ProPep® Nerve Monitoring System consists of an electroneurodiagnostic monitor (Pep Monitor®), a control switch that switches the surgical bipolar instrument between cautery and stimulation (Pep Control Switch®), and a single use, disposable needle electrode assembly (Pep Electrode®) which consists of two recording needle electrodes and a single-use, disposable introducer (Pep Electrode® Introducer). The introducer provides access to the abdominal space, and the electrodes are inserted through the introducer and placed in the pelvic floor muscles. Once in place, the system helps the surgeon:
- Identify the location and assess the integrity of non-visible nerves critical to urinary control and erectile function prior to prostate removal
- Verify the location of these nerves throughout the surgery
- Validate the integrity of the nerves after prostate removal
Critical points during the procedure where somatic nerves are at risk
- Posterior dissection
- Pedicle dissection
- Apical dissection
- Posterior reconstruction
- Anastomosis
- Wide excision cases
Patient Benefits = Surgeon Benefits
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Punnen, Sanoj. Long-term Health-related Quality of Life After Primary Treatment for Localized Prostate Cancer: Results from the CaPSURE Registry. European Association of Urology. 2015.
Donovan, J.L. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. New England Journal of Medicine. 2016.
*ProPep Clinical Study, University of Indiana, Department of Urology, 2018. Data on file.