Trial Outcomes & Findings for Combining Shockwave Therapy and Platelet Rich Plasma to Treat Erectile Dysfunction in Diabetic Men (COCKTAIL-DM) (NCT NCT05525572)

Results Overview

Markers of vasodilation including Endothelial Nitric Oxide Synthase (eNOS) and Neuronal Nitric Oxide Synthase (nNOS) will be measured from serum blood samples in units of ug/mL.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Baseline, Month 3, Month 6

Results posted on

2025-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection. Shockwave Therapy (SWT): Shockwave Therapy (SWT): 720 shocks will be administered administered in every session to each treated region (left and right corpora cavernosa and crura). Each session will last approximately 20 minutes. A total of 3600 shocks will be administered over 5 weekly sessions. Autologous Platelet-Rich Plasma (PRP): Autologous Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intra-cavernous penile injection with a 30 ± 7 day treatment interval.
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection. Shockwave Therapy (SWT): Shockwave Therapy (SWT): 720 shocks will be administered administered in every session to each treated region (left and right corpora cavernosa and crura). Each session will last approximately 20 minutes. A total of 3600 shocks will be administered over 5 weekly sessions. Autologous Platelet-Rich Plasma (PRP): Autologous Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intra-cavernous penile injection with a 30 ± 7 day treatment interval.
Overall Study Lost to Follow-up	2

Baseline Characteristics

Combining Shockwave Therapy and Platelet Rich Plasma to Treat Erectile Dysfunction in Diabetic Men (COCKTAIL-DM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group n=2 Participants Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection. Shockwave Therapy (SWT): Shockwave Therapy (SWT): 720 shocks will be administered administered in every session to each treated region (left and right corpora cavernosa and crura). Each session will last approximately 20 minutes. A total of 3600 shocks will be administered over 5 weekly sessions. Autologous Platelet-Rich Plasma (PRP): Autologous Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intra-cavernous penile injection with a 30 ± 7 day treatment interval.
Age, Continuous	57 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: Baseline blood samples unusable due to hemolysis and low cell recovery. Follow up data was not collected due to lost to follow up.

Markers of vasodilation including Endothelial Nitric Oxide Synthase (eNOS) and Neuronal Nitric Oxide Synthase (nNOS) will be measured from serum blood samples in units of ug/mL.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: Baseline blood samples unusable due to hemolysis and low cell recovery. Follow up data was not collected due to lost to follow up.

Markers of endothelial function will include Vascular Endothelial Growth Factor (VEGF), Stromal cell-derived factor 1 (SDF-1α), and Stem Cell Factor (SCF). All measured from serum blood samples in units of pg/mL.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline to Month 3, Baseline to Month 6

Population: Baseline blood samples unusable due to hemolysis and low cell recovery. Follow up data was not collected due to lost to follow up.

Markers of neo-angiogenesis reported as the percentage of Cluster of Differentiation 31 positive cells (CD31+), as measured from serum blood samples and expressed as a percentage.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: Baseline blood samples unusable due to low cell recovery. Follow up data was not collected due to lost to follow up.

Endothelial Progenitor Cell (EPC) Colony Forming Units (CFUs) as measured from peripheral blood samples in units of average cells per well.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: First subject completed baseline ultrasound. Second subject did not complete baseline ultrasound. Both subjects were lost to follow up before completing the month 6 visit. The measured value for Right EDV is "0.0", not a missing value.

Penile Blood Flow will be reported as Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV), both assessed in cm/sec, via Penile Doppler ultrasonography.

Outcome measures

Outcome measures
Measure	Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group n=1 Participants Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection. Shockwave Therapy (SWT): Shockwave Therapy (SWT): 720 shocks will be administered administered in every session to each treated region (left and right corpora cavernosa and crura). Each session will last approximately 20 minutes. A total of 3600 shocks will be administered over 5 weekly sessions. Autologous Platelet-Rich Plasma (PRP): Autologous Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intra-cavernous penile injection with a 30 ± 7 day treatment interval.
Penile Blood Flow Right Peak Systolic Velocity (PSV)	39.1 cm/sec
Penile Blood Flow Right End Diastolic Velocity (EDV)	0.0 cm/sec
Penile Blood Flow Left Peak Systolic Velocity (PSV)	35.4 cm/sec
Penile Blood Flow Left End Diastolic Velocity (EDV)	4.2 cm/sec

SECONDARY outcome

Timeframe: Month 3 and Month 6

Population: Data was not collected due to lost to follow up

Treatment satisfaction is assessed by the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire. EDITS questionnaire is an 11-item tool addressing participant satisfaction with ED therapy. Each item is a 5-point Likert-type scale from 0 "no satisfaction or dissatisfaction" to 4 "high satisfaction." Total scoring ranges from 0-44 with higher scores indicating higher treatment satisfaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, up to 6 months

Population: Both subjects were considered "lost to follow up" after completing baseline and Day 0 (treatment visit #1).

Incidence of Serious Adverse Events (SAEs), as assessed by study physician.

Outcome measures

Outcome measures
Measure	Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group n=2 Participants Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection. Shockwave Therapy (SWT): Shockwave Therapy (SWT): 720 shocks will be administered administered in every session to each treated region (left and right corpora cavernosa and crura). Each session will last approximately 20 minutes. A total of 3600 shocks will be administered over 5 weekly sessions. Autologous Platelet-Rich Plasma (PRP): Autologous Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intra-cavernous penile injection with a 30 ± 7 day treatment interval.
Incidence of Serious Adverse Events (SAEs)	0 events

Adverse Events

Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group

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

Thomas A Masterson, III

University of Miami, Miller School of Medicine

Phone: (305) 243 - 6260

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place