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
Key facts
- Who runs it
- Johns Hopkins University
- Where
- Baltimore, United StatesSee the site
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 3 people enrolled
- Started
- 1 Apr 2022
- Ended
- 25 Apr 2025
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Stravix lyopreserved placental tissue (LPT)
- Radical prostatectomy
- Record updated
- 30 January 2026
- Why it stopped
- The sponsor was unable to produce and provide the study material (stravix)
Who can take part
- Age
- 40 years to 65 years
- Sex
- Men only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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)
- Scheduled to undergo curative radical prostatectomy applying bilateral nerve-sparing procedure
- 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)
- Willingness to attempt intercourse at least 5 times per month following surgery
- Has a sexual partner of at least 6 months with current sexual activity (within the past 4 weeks)
Who cannot take part
- Pre or postoperative androgen therapy
- Pre or postoperative radiation therapy
- Taking nitrates medications
- Other contraindications to the use of phosphodiesterase inhibitor (PDE) 5 inhibitors
- Known penile deformity or a history of Peyronie's disease
- History of high or low blood pressure that is not controlled
- History of heart problems such as angina, heart failure, irregular heartbeats, or myocardial infarction
- History of drug or alcohol abuse
- Current smoker has a 20 pack/year history of cigarette smoking
- History of acute or chronic depression
- History of liver problems or kidney problems
- History of retinitis pigmentosa or severe vision loss, including a condition called NAION
- History of spinal trauma or surgery to the brain or spinal cord
- 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
Where in United States
- Johns Hopkins HospitalBaltimore, United StatesNo longer taking part
About the trial
What the trial wants to find out
Surgical implantation of Lyopreserved Placental Tissue (LPT) is 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. Surgical technique for nerve-sparing prostatectomy has evolved continuously since first described by Walsh in 1982 and is now commonly performed with robotic assistance.
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The investigators intend to study whether placement of LPT over the spared neurovascular bundle during nerve-sparing robotic prostatectomy will improve return to potency and/or continence after robotic radical prostatectomy for prostate cancer. Patients with a preoperative Sexual Health Inventory for Men (SHIM) score > 19 (moderate or high pre-op sexual function) planning to undergo robotic-assisted laparoscopic prostatectomy will be randomized to receive direct placement of LPT over the preserved neurovascular bundles vs standard of care. Patients will independently report erectile function and continence at 1 months, 3 months, 6 months and 1 year after surgery. Primary outcomes would include mean time to achieve potency, percentage of group achieving potency at each time point, and mean change in SHIM score. Secondary outcomes would include mean time to achieve continence. The investigators will also report any adverse events.
The 2 groups in the trial
- StravixTreatment being tested
Direct placement of LPT over the spared neurovascular bundles during bilateral nerve sparing radical prostatectomy for prostate cancer.
Treatment: Stravix lyopreserved placental tissue (LPT)
- Standard of CareSham treatment, for comparison
Standard care (no placement of tissue) bilateral nerve sparing radical prostatectomy for prostate cancer.
Treatment: Radical prostatectomy
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 30 January 2026