LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment

NCT ID: NCT05366504

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2024-03-31

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.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

Group Type: ACTIVE_COMPARATOR

LiST + PRP intracorporeal injection

Intervention Type: COMBINATION_PRODUCT

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).

Group B

Group Type: PLACEBO_COMPARATOR

LiST + Placebo(normal saline intracorporeal injection)

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

LiST + 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).

Intervention Type: COMBINATION_PRODUCT

LiST + 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.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Institute for the Study of Urological Diseases, Greece

OTHER

Sponsor Role: lead

Responsible Party

Dimitrios Hatzichristou

President, Institute for the Study of Urological Diseases Theesaloniki, Greece

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dimitrios Hatzichristou, Professor

Role: PRINCIPAL_INVESTIGATOR

G.Gennimatas General Hospital, Thessaloniki,Greece

Central Contacts

Paraskevi Kapoteli

Role: CONTACT

pkapotel@auth.gr

6948581395 ext. +30

Other Identifiers

IMOP

Identifier Type: -

Identifier Source: org_study_id