Clinical trial · Interventional
Miami Membrane for Potency (MMEP) Trial
Miami Membrane for Potency (MMeP) Trial to Assess the Impact of Dehydrated Human Amnion Membrane Allograft Placement During Robotic Radical Prostatectomy on Early Return of Erectile Function
NCT02710422CI-TRIAL-00040519MMEPterminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of Accrual and Inadequate Funding
Summary
Brief summary (as posted)
The use of dehydrated human amnionic membrane allograft improves erectile function recovery (as measured by (Sexual History Inventory for Men (SHIM) score) at 12 months after robotic assisted radical prostatectomy (RARP) compared to a control group with no allograft.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amniotic Membrane Placement | Biological | — | UNRESOLVED |
| EPIC 26 | Behavioral | — | UNRESOLVED |
| PSA Measurement | Other | — | UNRESOLVED |
| Sexual History Inventory for Men | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 - Amniotic Membrane Placement
- description
- Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.
- interventionNames
- Biological: Amniotic Membrane Placement
- Behavioral: EPIC 26
- Other: PSA Measurement
- Behavioral: Sexual History Inventory for Men
- type
- OTHER
- label
- Arm 2 - No Amniotic Membrane Placement
- description
- Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.
- interventionNames
- Behavioral: EPIC 26
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Men age 40-80 with localized prostate cancer who are undergoing bilateral nerve sparing RARP at the University of Miami Exclusion Criteria: * Men with poor urinary control at baseline requiring the use of pads for leakage * Previous treatment for prostate cancer * Previous history of pelvic radiation * Men who are using non-oral erectile aids such as vacuum pump, intra-cavernous injections, MUSE, penile prosthesis.
References
Publications (0)
Data not yet available
No reference posted for this study.