Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy
- Conditions
- Erectile Dysfunction Following Radical ProstatectomyProstate Cancer
- Interventions
- Biological: BioDFence G3 Placental Tissue MembraneProcedure: Robot-Assisted Radical Prostatectomy
- Registration Number
- NCT05842057
- Lead Sponsor
- University of Miami
- Brief Summary
The purpose of this research study is to evaluate if placing a dehydrated human amnion chorion membrane (dHACM) over the nerves after removal of the prostate during surgery (radical prostatectomy) will allow an earlier recovery of erectile function and urinary control after surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 240
- Men aged 40 to 80 years with localized prostate cancer who are undergoing bilateral nerve-sparing RARP at the University of Miami (UM).
- Men requiring any use of pads for urinary leakage.
- Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED)
- Men with baseline EPIC26 scores < 60.
- Previous treatment for prostate cancer.
- Previous history of pelvic radiation.
- Patients with impaired decision-making capacity.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Membrane Arm: dHACM Group BioDFence G3 Placental Tissue Membrane Participants will undergo standard of care robot-assisted radical prostatectomy (RARP) surgery and the dehydrated Human Amnion Chorion Membrane (dHACM) membrane placed after removal of the prostate. Participants will be in the group for approximately 12 months. Control Arm: No dHACM Group Robot-Assisted Radical Prostatectomy Participants will undergo standard of care RARP surgery but will have no dehydrated Human Amnion Chorion Membrane (dHACM) placed after removal of the prostate. Participants will be in the group for approximately 12 months. Membrane Arm: dHACM Group Robot-Assisted Radical Prostatectomy Participants will undergo standard of care robot-assisted radical prostatectomy (RARP) surgery and the dehydrated Human Amnion Chorion Membrane (dHACM) membrane placed after removal of the prostate. Participants will be in the group for approximately 12 months.
- Primary Outcome Measures
Name Time Method Change in Erectile Function Recovery as Measured by EPIC26 Sexual Domain Score Baseline, 12 Months Post-RARP Erectile function recovery among participants will be measured by the change in scores within the Sexual Domain of the Expanded Prostate Cancer Index Composite Short Form (EPIC26). The EPIC26 is a 26-item questionnaire used to measure health-related quality of life (HRQOL) among men with prostate cancer. The EPIC26 has five domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale with higher scores representing better HRQOL.
- Secondary Outcome Measures
Name Time Method Change in Erectile Function Recovery as Measured by SHIM Score Baseline, 12 Months Post-RARP Erectile function recovery among participants will be measured as the change in Sexual History Inventory for Men (SHIM). The SHIM is a health-related quality of life (HRQOL) questionnaire whose scores measure the severity of erectile dysfunction (ED) in men using points on a scale. The minimum score of 1 to 7 points indicates severe ED; a score of 8 to 11 points indicates moderate ED; a score of 12 to 15 points indicates mild-to-moderate ED; a score of 17 to 21 points indicates mild ED; and the maximum score of 22 to 25 points indicates no significant ED.
Number of Treatment-Related Adverse Events Up to 12 months post-RARP The number of treatment-related adverse events among participants will be assessed by treating physician using the Clavien-Dindo grading scale.
Change in Proportion of Participants with mild ED or Better as Defined by SHIM Score Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP Proportion of participants with mild ED or better as defined by a SHIM score greater than or equal to 17. The SHIM is a health-related quality of life (HRQOL) questionnaire whose scores measure the severity of erectile dysfunction (ED) in men using points on a scale. The minimum score of 1 to 7 points indicates severe ED; a score of 8 to 11 points indicates moderate ED; a score of 12 to 15 points indicates mild-to-moderate ED; a score of 17 to 21 points indicates mild ED; and the maximum score of 22 to 25 points indicates no significant ED.
Change in Rate of Urinary Control Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP Rate of urinary control as measured by EPIC26 question 3 that reports the number of participants requiring no pads per day.
Change in Proportion of Men with Mild ED or Better as Defined by EPIC26 Sexual Domain Score Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP Proportion of men with mild ED or better as defined by an EPIC26 Sexual Domain score greater than or equal to 60. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale with higher scores representing better sexual function.
Change in Proportion of Participants who Require the Use of More Invasive Erectile Aids Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP Proportion of participants who require the use of more invasive erectile aids (intra-cavernosal injection, vacuum pump, or penile prosthesis).
Change in Biochemical Failure Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP Biochemical failure among participants will measured as a prostate-specific antigen (PSA) level \> 0.2 ng/ml on two consecutive samples.
Change in Proportion of Participants with Erections Adequate for Penetration ≥ 50% of the time Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP Proportion of participants with erections adequate for penetration greater than or equal to 50-percent of the time.
Trial Locations
- Locations (1)
University of Miami
🇺🇸Miami, Florida, United States