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Status unknownNCT05366504Updated May 9, 2022

LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment

A Phase 2/3 interventional study of LiST + PRP intracorporeal injection and LiST + Placebo(normal saline intracorporeal injection) in Erectile Dysfunction, sponsored by Institute for the Study of Urological Diseases, Greece. Status unknown. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-09.

Sponsored by Institute for the Study of Urological Diseases, Greece · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Erectile Dysfunction

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03

In context

Erectile Dysfunction

701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 551 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Institute for the Study of Urological Diseases, Greece is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Group A

    Combination Product: LiST + PRP intracorporeal injection

  • Placebo comparator
    Group B

    Combination Product: LiST + Placebo(normal saline intracorporeal injection)

Interventions

  • Combination productLiST + PRP intracorporeal injection

    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).

  • Combination productLiST + Placebo(normal saline intracorporeal injection)

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: baseline and 4 weeks follow up visit

Secondary outcomes

  1. 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)

    Time frame: baseline and 12 weeks follow up visit

  2. 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

    Time frame: at 4 weeks follow up visit

  3. 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

    Time frame: at 12 weeks follow up visit

  4. 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

    Time frame: baseline and 4 weeks follow up visit

  5. 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

    Time frame: baseline and 12 weeks follow up visit

  6. 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

    Time frame: 28 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05366504
Lead sponsor
Institute for the Study of Urological Diseases, Greece
Responsible party
Dimitrios Hatzichristou (President, Institute for the Study of Urological Diseases Theesaloniki, Greece, Institute for the Study of Urological Diseases, Greece) — Principal investigator
First posted
May 9, 2022
Start date
Sep 2022 (estimated)
Primary completion
Dec 2023 (estimated)
Completion
Mar 2024 (estimated)
Last update
May 9, 2022

Study contacts

Paraskevi Kapoteli
Contact
pkapotel@auth.gr
6948581395 ext. +30
Dimitrios Hatzichristou, Professor
principal investigator · G.Gennimatas General Hospital, Thessaloniki,Greece

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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