Trial Outcomes & Findings for Miami Membrane for Potency (MMEP) Trial (NCT NCT02710422)
NCT ID: NCT02710422
Last Updated: 2019-09-11
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline, 12 Months Post-RARP
Results posted on
2019-09-11
Participant Flow
Participant milestones
| Measure |
Arm 1 - Amniotic Membrane Placement
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.
Amniotic Membrane Placement: 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.
EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
PSA Measurement: 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.
|
Arm 2 - No Amniotic Membrane Placement
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.
EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
PSA Measurement: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
3 Month Visit
|
9
|
11
|
|
Overall Study
6 Month Visit
|
7
|
8
|
|
Overall Study
9 Month Visit
|
5
|
5
|
|
Overall Study
12 Month Visit
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
| Measure |
Arm 1 - Amniotic Membrane Placement
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.
Amniotic Membrane Placement: 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.
EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
PSA Measurement: 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.
|
Arm 2 - No Amniotic Membrane Placement
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.
EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
PSA Measurement: 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.
|
|---|---|---|
|
Overall Study
Termination of study
|
9
|
9
|
Baseline Characteristics
Miami Membrane for Potency (MMEP) Trial
Baseline characteristics by cohort
| Measure |
Arm 1 - Amniotic Membrane Placement
n=12 Participants
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.
Amniotic Membrane Placement: 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.
EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
PSA Measurement: 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.
|
Arm 2 - No Amniotic Membrane Placement
n=12 Participants
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.
EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
PSA Measurement: 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.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Age, Continuous
|
60.33 years
STANDARD_DEVIATION 6.95 • n=39 Participants
|
61.25 years
STANDARD_DEVIATION 3.76 • n=41 Participants
|
60.79 years
STANDARD_DEVIATION 5.49 • n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=39 Participants
|
12 participants
n=41 Participants
|
24 participants
n=35 Participants
|
|
SHIM Score
|
19.25 points on a scale
STANDARD_DEVIATION 7.12 • n=39 Participants
|
21.25 points on a scale
STANDARD_DEVIATION 4.26 • n=41 Participants
|
20.25 points on a scale
STANDARD_DEVIATION 5.83 • n=35 Participants
|
|
PSA Level
|
7.29 ng/mL
STANDARD_DEVIATION 3.06 • n=39 Participants
|
6.76 ng/mL
STANDARD_DEVIATION 2.66 • n=41 Participants
|
7.03 ng/mL
STANDARD_DEVIATION 2.82 • n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 Months Post-RARPPopulation: Due to early study termination, not all study participants completed scheduled visits.
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.
Outcome measures
| Measure |
Arm 1 - Amniotic Membrane Placement
n=3 Participants
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.
Amniotic Membrane Placement: 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.
EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
PSA Measurement: 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.
|
Arm 2 - No Amniotic Membrane Placement
n=3 Participants
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.
EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
PSA Measurement: 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.
|
|---|---|---|
|
The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group
|
10 scores on a scale
Standard Deviation 12.288
|
13.33 scores on a scale
Standard Deviation 6.429
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 9 12 Months Post-RARPPopulation: Participants with a SHIM score of greater than or equal to 17 at baseline. Due to early study termination, not all study participants completed scheduled visits.
Among men with a SHIM greater than or equal to 17 at baseline, the investigators will compare the proportion of men in each group with mild ED or better, defined by a SHIM greater than or equal to 17, at 3, 6, 9 and 12 months post RARP.
Outcome measures
| Measure |
Arm 1 - Amniotic Membrane Placement
n=9 Participants
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.
Amniotic Membrane Placement: 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.
EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
PSA Measurement: 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.
|
Arm 2 - No Amniotic Membrane Placement
n=9 Participants
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.
EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
PSA Measurement: 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.
|
|---|---|---|
|
Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP
Mild or Better ED, Baseline
|
100 percentage of participants
|
100 percentage of participants
|
|
Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP
Mild or Better ED, 3 months
|
0 percentage of participants
|
0 percentage of participants
|
|
Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP
Mild or Better ED, 6 months
|
0 percentage of participants
|
0 percentage of participants
|
|
Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP
Mild or Better ED, 9 months
|
0 percentage of participants
|
0 percentage of participants
|
|
Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP
Mild or Better ED, 12 months
|
66.67 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 9 and 12 months Post-RARPPopulation: Participants with a SHIM score of greater than or equal to 17 at baseline. Due to early study termination, not all study participants completed scheduled visits.
Among men with a SHIM greater than or equal to 17 at baseline, the investigators will compare the proportion of men in each group who are able to achieve an erection sufficient for intercourse more than 50% of the time at 3, 6, 9 and 12 months post RARP.
Outcome measures
| Measure |
Arm 1 - Amniotic Membrane Placement
n=9 Participants
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.
Amniotic Membrane Placement: 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.
EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
PSA Measurement: 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.
|
Arm 2 - No Amniotic Membrane Placement
n=9 Participants
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.
EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
PSA Measurement: 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.
|
|---|---|---|
|
Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP.
3 months
|
0 percentage of participants
|
0 percentage of participants
|
|
Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP.
6 months
|
0 percentage of participants
|
0 percentage of participants
|
|
Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP.
9 months
|
0 percentage of participants
|
0 percentage of participants
|
|
Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP.
12 months
|
66.67 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 3, 6, 9 and 12 Months Post-RARPPopulation: Participants with a SHIM score of greater than or equal to 17 at baseline. Due to early study termination, not all study participants completed scheduled visits.
Among men with a SHIM greater than or equal to 17 at baseline, the investigators will evaluate the proportion of men who require the use of more invasive erectile aids (intra-cavernosal injection, vacuum pump, or penile prosthesis) at 3, 6, 9, and 12 months post RARP.
Outcome measures
| Measure |
Arm 1 - Amniotic Membrane Placement
n=9 Participants
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.
Amniotic Membrane Placement: 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.
EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
PSA Measurement: 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.
|
Arm 2 - No Amniotic Membrane Placement
n=9 Participants
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.
EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
PSA Measurement: 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.
|
|---|---|---|
|
Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP
3 months Post-RARP
|
0 percentage of participants
|
0 percentage of participants
|
|
Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP
6 months Post-RARP
|
0 percentage of participants
|
0 percentage of participants
|
|
Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP
9 months Post-RARP
|
0 percentage of participants
|
33.33 percentage of participants
|
|
Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP
12 months Post-RARP
|
66.67 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 9, and 12 months Post-RARPPopulation: Due to early study termination, not all study participants completed scheduled visits.
Rates of urinary control as measured by no pads per day at 3, 6, 9, and 12 months,
Outcome measures
| Measure |
Arm 1 - Amniotic Membrane Placement
n=12 Participants
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.
Amniotic Membrane Placement: 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.
EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
PSA Measurement: 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.
|
Arm 2 - No Amniotic Membrane Placement
n=12 Participants
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.
EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
PSA Measurement: 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.
|
|---|---|---|
|
Rates of Urinary Control Experienced by Study Participants
No Pad Usage: Baseline
|
100 percentage of participants
|
100 percentage of participants
|
|
Rates of Urinary Control Experienced by Study Participants
No Pad Usage: 12 months Post-RARP
|
100 percentage of participants
|
33.33 percentage of participants
|
|
Rates of Urinary Control Experienced by Study Participants
No Pad Usage: 3 months post-RARP
|
22.22 percentage of participants
|
27.27 percentage of participants
|
|
Rates of Urinary Control Experienced by Study Participants
No Pad Usage: 6 months Post-RARP
|
42.86 percentage of participants
|
50 percentage of participants
|
|
Rates of Urinary Control Experienced by Study Participants
No Pad Usage: 9 months Post-RARP
|
60 percentage of participants
|
60 percentage of participants
|
SECONDARY outcome
Timeframe: 5 years post-RARPPopulation: Data were not collected due to early termination of study.
Rate of prostate cancer recurrence in study participants in both study arms at 5 years post-radical prostatectomy.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 - Amniotic Membrane Placement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2 - No Amniotic Membrane Placement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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