LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment
Primary Purpose
Erectile Dysfunction
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
LiST + PRP intracorporeal injection
LiST + Placebo(normal saline intracorporeal injection)
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Consent to participate.
- Age 40-70 years.
- Sexually active in a stable, heterosexual relationship of more than three months duration.
- Presence of vasculogenic ED for at least 6 months.
- IIEF-ED: 11-21 at visit 2
- PDE5i users and report some/good response to PDE5i ( 5 points drop in the IIEF-ED after PDE5i wash-out) at the last month before screening.
- Agree to suspend all ED therapy for the duration of the study.
- Agree to attempt sexual intercourse at least 4 times every 4 weeks, for the duration of the study without being under the influence of alcohol or recreational drugs. Agree to document the outcome using the Sexual Encounter Profile (SEP) diary, as needed.
Exclusion Criteria:.
- Previous major pelvic surgery or pelvic trauma that could impact erectile function, such as radical prostatectomy, radical cystectomy, rectal surgery. Patients with previous TURP surgery without sequelae of iatrogenic ED, may be included.
- Previous penile surgery of any kind except circumcision and condyloma removal, such as penile lengthening, penile cancer surgery, penile plication, grafting.
- Previous history of priapism or penile fracture
- Previous radiation therapy to pelvis.
- Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (indicative of untreated hypogonadism), or greater than 1197 ng/dL.
- Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded.
- Psychogenic ED.
- Peyronie's Disease or penile curvature that negatively influences sexual activity.
- Anatomical or neurological abnormalities in the treatment area.
- Any untreated medical condition (medical history)
- Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's Disease.
- Refusal to suspend ED therapy for duration of study. Subjects who are using Tadalafil as a treatment for BPH (Benign Prostatic Hyperplasia) will also be excluded.
- Men deemed not healthy enough to participate in sexual activity.
- Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.
- Any health history or laboratory result that indicates to the Principal Investigator that the subject has a significant medical condition and should not participate in the study.
- History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
- Any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. Patients who are currently using SSRI or psychotropic medications.
- Partners who are < 18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have any gynecologic problems, sexual dysfunction, or major medical conditions that would limit participation in sexual intercourse.
- Patients with any hematological disorder.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group A
Group B
Arm Description
Outcomes
Primary Outcome Measures
The difference between the LiST plus PRP injection group and the LiST plus normal saline injection group in the change of the IIEF-ED score from baseline to 4 weeks after final treatment
EF domain of the IIEF questionnaire will be completed. IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction).
Secondary Outcome Measures
The difference between the LiST plus PRP injection group and the LiST plus normal saline injection group in the change of the IIEF-ED score from baseline to 12 weeks after final treatment
EF domain of the IIEF questionnaire will be completed.IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction)
The difference between the LiST plus PRP injection group and the LiST plus normal saline injection group in the % of patients who attain MCID in IIEF-EF domain from baseline to 4 weeks after final treatment.
MCID is defined according to baseline ED severity as:Improvement by 5 or more in the EF domain score of the IIEF for patients with moderate ED at baseline and by 2 or more in the EF domain score of the IIEF for patients with moderate ED at baseline
The difference between the LiST plus PRP injection group and the LiST plus normal saline injection group in the % of patients who attain MCID in IIEF-EF domain from baseline to 12 weeks after final treatment.
MCID is defined according to baseline ED severity as:Improvement by 5 or more in the EF domain score of the IIEF for patients with moderate ED at baseline and by 2 or more in the EF domain score of the IIEF for patients with moderate ED at baseline
The difference between the LiST plus PRP injection group and the LiST plus normal saline injection group in the change of Sexual Encounter Profile Question 3 (SEP3) %Yes score from baseline to 4 weeks after final treatment.
The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported
The difference between the LiST plus PRP injection group and the LiST plus normal saline injection group in the change of Sexual Encounter Profile Question 3 (SEP3) %Yes score from baseline to 12 weeks after final treatment.
The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported
Number of patients with treatment related adverse events
Potential treatment related adverse events after the first treatment session and during the 3 month follow up period will be reported
Full Information
NCT ID
NCT05366504
First Posted
May 4, 2022
Last Updated
May 4, 2022
Sponsor
Institute for the Study of Urological Diseases, Greece
1. Study Identification
Unique Protocol Identification Number
NCT05366504
Brief Title
LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment
Official Title
Is Combined Low Intensity Shockwave Therapy (LiST) Plus Platelet-rich Plasma (PRP) Injection Therapy Better Than LiST Monotherapy for the Improvement of Erectile Function? a Double-blind, Randomized, Placebo-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute for the Study of Urological Diseases, Greece
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
We designed a double blind randomized sham-controlled trial in order to investigate and compare the treatment efficacy of LiST plus PRP intracorporeal injection vs LiST plus placebo (normal saline intracorporeal injection) in men with moderate and mild to moderate vasculogenic ED, as measured by IIEF-EF.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Title
Group B
Arm Type
Placebo Comparator
Intervention Type
Combination Product
Intervention Name(s)
LiST + PRP intracorporeal injection
Intervention Description
12 LiST sessions (2 sessions per week) plus PRP (2 intracorporeal injections 3 weeks apart, after the 1st and the 7th LiST sessions) ( 30 patients).
Intervention Type
Combination Product
Intervention Name(s)
LiST + Placebo(normal saline intracorporeal injection)
Intervention Description
All subjects of this group will receive 12 sessions (V3-V14) of LiST with session frequency 2/week and 2 normal saline injections with 3 weeks treatment interval (V3 and V9), 10 ml of normal saline will be injected at each session.
Primary Outcome Measure Information:
Title
The difference between the LiST plus PRP injection group and the LiST plus normal saline injection group in the change of the IIEF-ED score from baseline to 4 weeks after final treatment
Description
EF domain of the IIEF questionnaire will be completed. IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction).
Time Frame
baseline and 4 weeks follow up visit
Secondary Outcome Measure Information:
Title
The difference between the LiST plus PRP injection group and the LiST plus normal saline injection group in the change of the IIEF-ED score from baseline to 12 weeks after final treatment
Description
EF domain of the IIEF questionnaire will be completed.IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction)
Time Frame
baseline and 12 weeks follow up visit
Title
The difference between the LiST plus PRP injection group and the LiST plus normal saline injection group in the % of patients who attain MCID in IIEF-EF domain from baseline to 4 weeks after final treatment.
Description
MCID is defined according to baseline ED severity as:Improvement by 5 or more in the EF domain score of the IIEF for patients with moderate ED at baseline and by 2 or more in the EF domain score of the IIEF for patients with moderate ED at baseline
Time Frame
at 4 weeks follow up visit
Title
The difference between the LiST plus PRP injection group and the LiST plus normal saline injection group in the % of patients who attain MCID in IIEF-EF domain from baseline to 12 weeks after final treatment.
Description
MCID is defined according to baseline ED severity as:Improvement by 5 or more in the EF domain score of the IIEF for patients with moderate ED at baseline and by 2 or more in the EF domain score of the IIEF for patients with moderate ED at baseline
Time Frame
at 12 weeks follow up visit
Title
The difference between the LiST plus PRP injection group and the LiST plus normal saline injection group in the change of Sexual Encounter Profile Question 3 (SEP3) %Yes score from baseline to 4 weeks after final treatment.
Description
The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported
Time Frame
baseline and 4 weeks follow up visit
Title
The difference between the LiST plus PRP injection group and the LiST plus normal saline injection group in the change of Sexual Encounter Profile Question 3 (SEP3) %Yes score from baseline to 12 weeks after final treatment.
Description
The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported
Time Frame
baseline and 12 weeks follow up visit
Title
Number of patients with treatment related adverse events
Description
Potential treatment related adverse events after the first treatment session and during the 3 month follow up period will be reported
Time Frame
28 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consent to participate.
Age 40-70 years.
Sexually active in a stable, heterosexual relationship of more than three months duration.
Presence of vasculogenic ED for at least 6 months.
IIEF-ED: 11-21 at visit 2
PDE5i users and report some/good response to PDE5i ( 5 points drop in the IIEF-ED after PDE5i wash-out) at the last month before screening.
Agree to suspend all ED therapy for the duration of the study.
Agree to attempt sexual intercourse at least 4 times every 4 weeks, for the duration of the study without being under the influence of alcohol or recreational drugs. Agree to document the outcome using the Sexual Encounter Profile (SEP) diary, as needed.
Exclusion Criteria:.
Previous major pelvic surgery or pelvic trauma that could impact erectile function, such as radical prostatectomy, radical cystectomy, rectal surgery. Patients with previous TURP surgery without sequelae of iatrogenic ED, may be included.
Previous penile surgery of any kind except circumcision and condyloma removal, such as penile lengthening, penile cancer surgery, penile plication, grafting.
Previous history of priapism or penile fracture
Previous radiation therapy to pelvis.
Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (indicative of untreated hypogonadism), or greater than 1197 ng/dL.
Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded.
Psychogenic ED.
Peyronie's Disease or penile curvature that negatively influences sexual activity.
Anatomical or neurological abnormalities in the treatment area.
Any untreated medical condition (medical history)
Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's Disease.
Refusal to suspend ED therapy for duration of study. Subjects who are using Tadalafil as a treatment for BPH (Benign Prostatic Hyperplasia) will also be excluded.
Men deemed not healthy enough to participate in sexual activity.
Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.
Any health history or laboratory result that indicates to the Principal Investigator that the subject has a significant medical condition and should not participate in the study.
History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
Any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. Patients who are currently using SSRI or psychotropic medications.
Partners who are < 18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have any gynecologic problems, sexual dysfunction, or major medical conditions that would limit participation in sexual intercourse.
Patients with any hematological disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paraskevi Kapoteli
Phone
6948581395
Ext
+30
Email
pkapotel@auth.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitrios Hatzichristou, Professor
Organizational Affiliation
G.Gennimatas General Hospital, Thessaloniki,Greece
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment
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