LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment

NCT05366504 | Unknown Phase 2

• 1 other identifier: IMOP
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

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).

  baseline and 4 weeks follow up visit

Secondary Outcomes (6)

• 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

  baseline and 12 weeks follow up visit

• 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.

  at 4 weeks follow up visit

• 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.

  at 12 weeks follow up visit

• 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.

  baseline and 4 weeks follow up visit

• 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.

  baseline and 12 weeks follow up visit

Study Arms (2)

Group A

ACTIVE COMPARATOR

Combination Product: LiST + PRP intracorporeal injection

Group B

PLACEBO COMPARATOR

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

Interventions

LiST + PRP intracorporeal injection 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 A

LiST + Placebo(normal saline intracorporeal injection) 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.

Group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute for the Study of Urological Diseases, Greece: lead

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Dimitrios Hatzichristou, Professor

  G.Gennimatas General Hospital, Thessaloniki,Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paraskevi Kapoteli

CONTACT

6948581395; pkapotel@auth.gr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, Institute for the Study of Urological Diseases Theesaloniki, Greece

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share