Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Johns Hopkins University
Age
40–65
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
1. Male sex 40 to 65 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 (Gleason 8 or 4+3=7 will be excluded), Prostate-Specific Antigen (PSA) less than or equal to 10 ng/mL)
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)
You may not be if
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 phosphodiesterase inhibitor (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: