Using amnion membrane to improve erectile function after prostate surgery
Phase 2 Randomized Trial: Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy (HAMMER)
This study is testing if using a special membrane during prostate surgery can help men recover their erectile function and urinary control faster after the operation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | Male |
| Sponsor | University of Miami Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT05842057 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of applying a dehydrated human amnion chorion membrane (dHACM) over the nerves during radical prostatectomy to enhance recovery of erectile function and urinary control. The study involves men aged 40 to 80 with localized prostate cancer undergoing bilateral nerve-sparing surgery at the University of Miami. Participants will receive the BioDFence G3 Placental Tissue Membrane during their procedure. The goal is to determine if this intervention can lead to earlier recovery compared to standard surgical practices.
Who should consider this trial
Good fit: Ideal candidates are men aged 40 to 80 with localized prostate cancer who are scheduled for bilateral nerve-sparing radical prostatectomy.
Not a fit: Patients who have a history of pelvic radiation, require non-oral erectile aids, or have significant urinary leakage may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the speed and quality of recovery of erectile function in men after prostate surgery.
How similar studies have performed: While the use of amnion membranes in surgical procedures is gaining interest, this specific application in prostate surgery is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Men aged 40 to 80 years with localized prostate cancer who are undergoing bilateral nerve-sparing RARP at the University of Miami (UM). Exclusion Criteria: 1. Men requiring any use of pads for urinary leakage. 2. Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED) 3. Men with baseline EPIC26 scores \< 60. 4. Previous treatment for prostate cancer. 5. Previous history of pelvic radiation. 6. Patients with impaired decision-making capacity.
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Sanoj Punnen, MD, MAS — University of Miami
- Study coordinator: Sanoj Punnen, MD, MAS
- Email: s.punnen@med.miami.edu
- Phone: 305-243-3246
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.