Patient-Reported Erectile Recovery and Quality of Life Outcomes With Lyopreserved Placental Tissue Applied Directly Over Neurovascular Bundle During Nerve-Sparing Radical Prostatectomy Versus Standard of Care
Phase: PHASE2
Conditions: Prostate Cancer
Sponsor: Johns Hopkins University

NCT number: NCT05366842 
Study title: Assessment of clinical outcomes post 
application of StravixPL for robotic prostatectomy 
Date of the study protocol: 7/03/2023 

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Johns Hopkins Medicine - eIRB Protocol (eForm A) 
 
 
∙    Assessment of clinical outcomes post application of StravixPL for robotic 
prostatectomy 
*********************************************************************************** 
7/03/2023 
1.    Abstract 
Erectile dysfunction is common in patients undergoing radical prostatectomy for prostate 
cancer and is thought to result from disruption of normal blood and nerve supply to the penis. 
There have been significant advances in surgical technique, including nerve sparing 
prostatectomy, as well as post prostatectomy penile rehabilitation, which have improved 
erectile recovery after surgery. Clinical use of growth factors and anti-inflammatory substances 
for prostate neurovascular bundle regrowth have emerged as a new technique to further 
enhance recovery of potency and potentially continence after prostate surgery.  Patel et al. 
studied outcomes after placement of a dehydrated chorionic allograft membrane on 
neurovascular bundles during prostatectomy and reported that 65.5% of patients with 
moderate to high preoperative sexual function had return to potency at 8 weeks vs. 51.7% of 
patients with standard care1.  The mean time to recovery was 1.34 months1.  Johnson et al. 
compared viable to nonviable dehydrated placenta for chronic wounds and showed superior 
outcomes with viable tissue2.  
  
Surgical implantation of Stravix (Smith and Nephew. Columbia, MD), a lyopreserved placental 
tissue (LPT) is now FDA approved and has been used extensively in wound care.  The use is 
expanding and more recently, LPT has been used in the management of diabetic foot ulcers, 
acute and chronic surgical wounds, various fistulas and even as a nerve wrap on the common 
peroneal nerve (Rodriguez, Foot and Ankle, 2017)3.   
  
We intend to study whether placement of LPT over the spared neurovascular bundles during 
nerve-sparing prostatectomy will improve return to potency and/or continence after radical 
prostatectomy for prostate cancer.  This research could provide a potentially meaningful 
advancement in quality of life outcomes for patients undergoing radical prostatectomy for 
prostate cancer.  
2.    Study Procedures 
This is a single center, randomized; singe blinded, two-arm trial comparing the effects of direct 
placement of LPT over the spared neurovascular bundles vs. standard care (no placement of 
tissue) on erectile recovery and quality of life in patients undergoing bilateral nerve sparing 
radical prostatectomy for prostate cancer.   
 

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The sample size will be 10 patients randomized to each study arm (20 patients total). Study 
procedures will involve screening and informed consent after initial consultation, baseline 
evaluation including medical clearance and completion of validated questionnaires, and 
randomization. 
 
In order to minimize the need for research-only in-person visits, telemedicine visits may be substituted for in 
person clinical trial visits or portions of clinical trial visits where determined to be appropriate and where 
determined by the investigator not to increase the participant’s risks. Prior to initiating telemedicine for study 
visits the study team will explain to the participant, what a telemedicine visit entails and confirm that the 
study participant is in agreement and able to proceed with this method. Telemedicine acknowledgement will 
be obtained in accordance with the Guidance for Use of Telemedicine in Research. In the event 
telemedicine is not deemed feasible, the study visit will proceed as an in-person visit. Telemedicine visits will 
be conducted using HIPAA compliant method approved by the Health System and within licensing 
restrictions 
 
 
Assessment tools will consist of the following questionnaires, which will be administered online 
using a REDCap site hosted by the Data Informatics Services Core within the Johns Hopkins 
Biostatistics Center or via mail per patient preference: IIEF questionnaire, the Quality of 
Erection Questionnaire (QEQ), and the version of the Expanded Prostate Cancer Index 
Composite (EPIC) that combines the Short Form Health Survey (SF-12) and AUA Symptom 
Index (AUA-SI). Standard practice associated with surgery, blood transfusion and 
postoperative laboratory testing will be performed. Operating room time, estimated blood loss, 
surgical margin status and length of hospital stay will be recorded. Patients will be prescribed a 
phosphodiesterase type 5 inhibitor (sildenafil, tadalafil or vardenafil) at 1 month following 
surgery to be used as conventional “on-demand” therapy. Adverse event monitoring will be 
performed. PSA monitoring is recommended at 3 and 12 months with the definition for 
biochemical recurrence set as a PSA of 0.2ng/mL (rising from an undetectable level after 
surgery). 
 
 
 
 
 
 
 
 
 

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3.    Inclusion/Exclusion Criteria 
 
Inclusion Criteria: 
 
1. Male sex 40 to 70 years of age with localized prostate cancer (clinical stage less than or 
equal to T2a, Gleason grade less than or equal to 3+4=7, including 4+3=7 (Gleason 8 will be 
excluded), PSA less than or equal to 20 ng/mL) 
2. Scheduled to undergo curative radical prostatectomy applying bilateral nerve-sparing 
procedure 
3. Intact pre-surgical erectile function (International Index of Erectile Function [IIEF]-5 / Sexual 
Health Inventory for Men (SHIM) score greater than or equal to 18) 
4. Willingness to attempt intercourse at least 5 times per month following surgery. 
5. Has a sexual partner of at least 6 months with current sexual activity (within the past 4 
weeks) 
 
Exclusion criteria: 
1. Known penile deformity or a history of Peyronie’s disease 
2. Pre or postoperative androgen therapy 
3. Pre or postoperative radiation therapy 
4. History of high or low blood pressure that is not controlled 
5. Taking nitrates medications 
6. History of heart problems such as angina, heart failure, irregular heartbeats, or myocardial 
infarction 
7. History of drug or alcohol abuse 
8. Current smoker has a 20 pack/year history of cigarette smoking 
9. History of acute or chronic depression 
10. History of liver problems or kidney problems 
11. History of retinitis pigmentosa or severe vision loss, including a condition called NAION 
12. History of spinal trauma or surgery to the brain or spinal cord 
13. Other contraindications to the use of PDE 5 inhibitors 
14. History of known sensitivities to any of the following reagents used for processing, 
disinfection, and storage, which may remain on the product: 
 
• Lyopreservation Solution: 18.9% w/v Trehalose in Dulbecco’s Phosphate Buffered Saline  
• Disinfection Solution: 0.5% v/v Gentamicin Sulfate, 0.1% v/v Vancomycin reconstituted in  
Water for Injection (WFI), 1% v/v Amphotericin B, 98.4% Dulbecco’s Modified Eagle’s 
 Medium (DMEM)  
• Processing Solution: DMEM, Dulbecco’s Phosphate Buffered Saline (dPBS),  
11% Anticoagulant Citrate Dextrose Solution in Saline, Formula A (ACD-A), 1.7% w/v  
Trehalose in Dulbecco’s Phosphate Buffered Saline  
 
 
 
 
 
 
 

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4.  Drugs/Substances/Devices 
a.   The rationale for choosing the drug or substance dose or for choosing the device to 
be used. 
Stravix (Smith and Nephew. Columbia, MD) is a Lyopreservation placental tissue that is FDA 
approved for homologous use as a wound cover or surgical wrap. There are no known 
contraindications to the use of Stravix. The product is available for use at Johns Hopkins and 
has been used by the pediatric urology department in the management of rectovaginal fistula4 
it has also been used by the colorectal surgery department. Novel clinical use of growth factors 
and anti-inflammatory substances for prostatic neurovascular bundle regeneration has been 
shown with the use of a dehydrated human chorion membrane1.  Chronic wound studies have 
shown viable chorionic tissue, such as Stravix, to be superior to non-viable dehydrated 
chorionic tissue2.  We plan to prospectively study surgical placement of Stravix directly to 
neurovascular bundles and assess for improvement in erectile recovery as well as quality of 
life after radical prostatectomy for prostate cancer. 
5.    Study Statistics 
The primary outcome variable is the patient’s score on the IIEF questionnaire (erectile function 
domain) at 1,3, 6, 9, 12 and 18 months post-surgery. Comparison of changes in initial IIEF 
score will be evaluated to determine treatment efficacy. We anticipate a gradual increase in 
baseline IIEF score over the course of the study. The secondary outcome variables will be the 
patient’s scores on the QEQ, combined EPIC/SF-12/AUASI questionnaires, other domains of 
the IIEF questionnaire.  For statistical analysis based on ANOVA, the sample size is powered 
for a power of 80% with one-sided alpha of 0.05 showing a sample size of 23 patients in each 
arm is necessary to detect an expected difference of 5 points in IIEF scores (i.e. 20 vs. 15) at 6 
months post-surgery. Therefore, the study is planned to enroll 30 patients in each arm. This 
sample size will accommodate dropout rate during follow-up.  
6.    Risks 
Completion of the questionnaires and administration of Stravix are the only 2 procedures from 
this protocol that are outside of the realm of standard of care for the radical prostatectomy 
patient. All of the participants will be exposed to the questionnaires pre operatively and can 
assess whether they are willing to complete the trial, which will include 6 additional 
administrations of the questionnaires. If the questionnaires cause any type of discomfort or 
uneasiness at that time or any time during the study, the participant can decide to end their 
involvement with the protocol. 
There are no contraindications to the use of Stravix. Smith and Nephew (Columbia, MD) 
reports that the product has been directly applied to spared neurovascular bundles in 
approximately 250 radical prostatectomies. Tissue donor screening methods are limited; 
therefore, certain diseases may not be detected.  

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The following complications of tissue transplantation may occur:5 
• Transmission of diseases of unknown etiology; 
• Transmission of known infectious agents including, but not limited to, viruses, bacteria, and 
fungi; 
• Immune rejection of implanted Stravix®; or 
• Loss of function and/or integrity of Stravix® due to resorption, fragmentation, and/or 
disintegration. 
The occurrence of any serious adverse effects will end the patient’s participation in the study 
and halt enrollment in the study to determine the safety of continuing the study. Each and 
every possible adverse effect of LPT will be investigated and treated individually to minimize 
the participant’s discomfort.  The safety of having the individual complete the study will also be 
assessed on an individual basis. At any time the participant can decide to terminate his 
participation in the study and no penalty or loss of benefits to which they are entitled. 
The risks of radical prostatectomy will apply to both groups. These include but are not limited 
to bleeding, infection, and injury to surrounding structures.  Rare complications include rectal 
injury requiring fecal diversion and acute blood loss anemia requiring transfusion.  An 
ejaculation is expected. Late complications include urinary incontinence, erectile dysfunction, 
urethral stricture disease, and bladder neck contracture.   
7.    Confidentiality 
Paper consent forms, enrollment check sheets, and other source or study documentation will 
be kept in a study binder. This binder will be stored in a locked office available only to the 
study team. Electronic data will be housed in a secure password protected REDCap database 
maintained by the Data Informatics Services Core within the Johns Hopkins Biostatistics 
Center. Only the study team will have access to this secure database. Of note, to maintain the 
protected health information of patients enrolled in this study, only the study Principal 
Investigator and primary coordinators will have the ability to export data containing identifying 
information from this master database. For the purposes of analysis, only de-identified data will 
be exported. 
 
8.    Benefits 
The patient’s conditions may improve as a result of participation in this study, specifically as 
related to erectile function and quality of life. However, there is no guarantee of this. The 
information from this research study may lead to a better treatment in the future for people with 
prostate cancer. The patients may not benefit from participation in this study. Their conditions 
may not get better or may become worse while they are in this study. 
9.  Payment and Remuneration    
There will be no payment or remuneration for the participants in this study. 
 

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10.  Costs 
The cost of the Stravix will be covered by the study. There are no other anticipated costs 
outside of usual care. The participant’s insurance, as part of routine care after radical 
prostatectomy, will be charged for the PDE5 inhibitor drugs such as Viagra, Cialis or Levitra. If 
the PDE5 inhibitor (Viagra, Cialis or Levitra) is not covered by the participants insurance, they 
will be responsible for the bill. 
 
Sources 
 
1. Patel, Vipul R., et al. “Dehydrated Human Amnion/Chorion Membrane Allograft Nerve Wrap Around 
the Prostatic Neurovascular Bundle Accelerates Early Return to Continence and Potency Following 
Robot-Assisted Radical Prostatectomy: Propensity Score–Matched Analysis.” European Urology, vol. 
67, no. 6, 2015, pp. 977–980., doi:10.1016/j.eururo.2015.01.012. 
 
2. Johnson, Eric L., et al. “A Comparative Outcomes Analysis Evaluating Clinical Effectiveness in Two 
Different Human Placental Membrane Products for Wound Management.” Wound Repair and 
Regeneration, vol. 25, no. 1, 2017, pp. 145–149. doi:10.1111/wrr.12503. 
 
3. Rodriguez-Collazo, E., and Y. Tamire. “Open Surgical Implantation of a Viable Cryopreserved Placental 
Membrane after Decompression and Neurolysis of Common Peroneal Nerve: a Case Series.” Journal of 
Orthopedic Surgery and Research, vol. 12, no. 1, Dec. 2017, doi: 10.1186/s13018-017-0587-y. 
 
4. Taylor, Jp, and S Gearhart. “The Use of Viable Cryopreserved Placental Tissue in the Management of a 
Chronic Rectovaginal Fistula.” The Annals of The Royal College of Surgeons of England, vol. 99, no. 8, 
2017, doi:10.1308/rcsann.2017.0157.