Trial Outcomes & Findings for 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 (NCT NCT05366842)
NCT ID: NCT05366842
Last Updated: 2026-01-30
Results Overview
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. A comparison of changes in the initial IIEF score will be evaluated to determine treatment efficacy. The IIEF contains 15 questions. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. Overall scores will be categorized as follows: * 1-10: Severe Erectile Dysfunction * 11-16: Moderate dysfunction. * 17-21: Mild to moderate dysfunction * 22-25: Mild dysfunction * 26-30: No dysfunction
TERMINATED
PHASE2
3 participants
1, 3, 6, 9, 12 and 18 months post-surgery
2026-01-30
Participant Flow
Participant milestones
| Measure |
Stravix
Direct placement of LPT over the spared neurovascular bundles during bilateral nerve sparing radical prostatectomy for prostate cancer.
Stravix lyopreserved placental tissue (LPT): Participants will undergo surgical implantation of Stravix lyopreserved placental tissue (LPT) during a standard of care radical prostatectomy.
|
Standard of Care
Standard care (no placement of tissue) bilateral nerve sparing radical prostatectomy for prostate cancer.
Radical prostatectomy: Standard care (no placement of tissue)
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Stravix
n=2 Participants
Direct placement of LPT over the spared neurovascular bundles during bilateral nerve sparing radical prostatectomy for prostate cancer.
Stravix lyopreserved placental tissue (LPT): Participants will undergo surgical implantation of Stravix lyopreserved placental tissue (LPT) during a standard of care radical prostatectomy.
|
Standard of Care
n=1 Participants
Standard care (no placement of tissue) bilateral nerve sparing radical prostatectomy for prostate cancer.
Radical prostatectomy: Standard care (no placement of tissue)
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: 1, 3, 6, 9, 12 and 18 months post-surgeryPopulation: Data not collected. Study terminated before data collection
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. A comparison of changes in the initial IIEF score will be evaluated to determine treatment efficacy. The IIEF contains 15 questions. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. Overall scores will be categorized as follows: * 1-10: Severe Erectile Dysfunction * 11-16: Moderate dysfunction. * 17-21: Mild to moderate dysfunction * 22-25: Mild dysfunction * 26-30: No dysfunction
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1, 3, 6, 9, 12 and 18 months post-surgeryPopulation: Data not collected. Study terminated before data collection
The following questionnaires will be combined into a composite index EPIC score. EPIC scoring involves linear standardization of the response for each questionnaire to a 0 to 100 scale. Using the item groupings for each health-related quality of life (HRQOL) Domain Summary Score or Subscale score, values are averaged for all items within a group to create the summary or subscale score. A higher score represents better HRQOL. EPIC scores will be compared at each time point. A clinically relevant increase for the sexual domain is 10-12 points. * The Quality of Erection Questionnaire (QEQ) assesses erection in terms of hardness, onset, duration, and changes in erection quality. There are 6 questions. * The Short Form Survey (SF-12) assesses 8 health domains: Physical Functioning, Role-Physical, Bodily Pain, etc with 1-2 questions per domain. * The MUSIC questionnaire assesses four domains: urinary, bowel, sexual and hormonal. Each domain consists of 2-4 questions.
Outcome measures
Outcome data not reported
Adverse Events
Stravix
Standard of Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place