Clinical trial NCT05366504: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Erectile Dysfunction
Lead sponsor: Institute for the Study of Urological Diseases, Greece
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Consent to participate.
2. Age 40-70 years.
3. Sexually active in a stable, heterosexual relationship of more than three months duration.
4. Presence of vasculogenic ED for at least 6 months.
5. IIEF-ED: 11-21 at visit 2
6. 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.
7. Agree to suspend all ED therapy for the duration of the study.
8. 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:.

1. 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.
2. Previous penile surgery of any kind except circumcision and condyloma removal, such as penile lengthening, penile cancer surgery, penile plication, grafting.
3. Previous history of priapism or penile fracture
4. Previous radiation therapy to pelvis.
5. Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (indicative of untreated hypogonadism), or greater than 1197 ng/dL.
6. 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.
7. Psychogenic ED.
8. Peyronie's Disease or penile curvature that negatively influences sexual activity.
9. Anatomical or neurological abnormalities in the treatment area.
10. Any untreated medical condition (medical history)
11. Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's Disease.
12. 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.
13. Men deemed not healthy enough to participate in sexual activity.
14. Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.
15. 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.
16. History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
17. 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.
18. 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.
19. Patients with any hematological disorder.

Primary outcomes:
measure: 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
timeFrame: baseline and 4 weeks follow up visit
Secondary outcomes:
measure: 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
timeFrame: baseline and 12 weeks follow up visit
measure: 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.
timeFrame: at 4 weeks follow up visit
measure: 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.
timeFrame: at 12 weeks follow up visit
measure: 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.
timeFrame: baseline and 4 weeks follow up visit
measure: 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.
timeFrame: baseline and 12 weeks follow up visit
measure: Number of patients with treatment related adverse events
timeFrame: 28 weeks
Other outcomes:
Locations:
Study officials:
affiliation: G.Gennimatas General Hospital, Thessaloniki,Greece
name: Dimitrios Hatzichristou, Professor
role: PRINCIPAL_INVESTIGATOR
References: