Study Stopped
Lack of Accrual and Inadequate Funding
Miami Membrane for Potency (MMEP) Trial
MMEP
1 other identifier
interventional
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 prostate-cancer
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2016
CompletedFirst Posted
Study publicly available on registry
March 16, 2016
CompletedStudy Start
First participant enrolled
May 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2019
CompletedResults Posted
Study results publicly available
September 11, 2019
CompletedSeptember 11, 2019
August 1, 2019
2.7 years
March 11, 2016
July 27, 2019
August 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group
The difference in average change in Sexual History Inventory for Men (SHIM) score, between baseline and 12 months post RARP between the membrane and control arms will be assessed as the primary endpoint. The SHIM score is measured in points on a scale: The minimum score is 5 to 7 indicating severe erectile dysfunction (ED), the maximum score is 22 to 25, indicating no ED.
Baseline, 12 Months Post-RARP
Secondary Outcomes (5)
Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP
Baseline, 3, 6, 9 12 Months Post-RARP
Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP.
Baseline, 3, 6, 9 and 12 months Post-RARP
Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP
3, 6, 9 and 12 Months Post-RARP
Rates of Urinary Control Experienced by Study Participants
Baseline, 3, 6, 9, and 12 months Post-RARP
5-year Rate of Prostate Cancer Recurrence Between Both Study Arms
5 years post-RARP
Study Arms (2)
Arm 1 - Amniotic Membrane Placement
EXPERIMENTALParticipants 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.
Arm 2 - No Amniotic Membrane Placement
OTHERParticipants 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.
Interventions
Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately.
Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.
SHIM psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.
Eligibility Criteria
You may qualify if:
- Men age 40-80 with localized prostate cancer who are undergoing bilateral nerve sparing RARP at the University of Miami
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Vivex Biomedicalcollaborator
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to early study termination, not all study participants completed scheduled visits.
Results Point of Contact
- Title
- Sanoj Punnen MD, MAS
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Sanoj Punnen, MD
University of Miami
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will not know their treatment arm assignment until after robotic assisted radical prostatectomy (RARP) surgery.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Clinical
Study Record Dates
First Submitted
March 11, 2016
First Posted
March 16, 2016
Study Start
May 17, 2016
Primary Completion
January 22, 2019
Study Completion
January 22, 2019
Last Updated
September 11, 2019
Results First Posted
September 11, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share