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
Public ClinicalTrials.gov record NCT05366842. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. 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.
Study identification
- NCT ID
- NCT05366842
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 3 participants
Conditions and interventions
Conditions
Interventions
- Stravix lyopreserved placental tissue (LPT) Drug
- Radical prostatectomy Procedure
Drug · Procedure
Eligibility (public fields only)
- Age range
- 40 Years to 65 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2022
- Primary completion
- Apr 24, 2025
- Completion
- Apr 24, 2025
- Last update posted
- Jan 29, 2026
2022 – 2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05366842, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 29, 2026 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05366842 live on ClinicalTrials.gov.