Low-intensity Shockwave Therapy (LiST) for the Treatment of Mild and Mild-to-moderate Vasculogenic Erectile Dysfunction

NCT03641846 | Completed

• 1 other identifier: 10672/2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, 2 parallel arms clinical trial. All patients will be PDE5I users/responders. After 1 month wash-out period, ED patients will be screened, in order to randomize 50 men with vasculogenic ED with primary objective to examine the efficacy of LiST using Aries2 device.

Conditions

Erectile Dysfunction; Low Intensity Shockwave Therapy

Outcome Measures

Primary Outcomes (1)

• Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF)

  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 12-week follow-up visit

Secondary Outcomes (6)

• Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF)

  baseline and 4-week follow-up visit

• Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF)

  baseline and 24-week follow-up visit

• Change in Sexual Encounter Profile Question 3 (SEP3) score

  baseline and 4-week follow-up visit

• Change in Sexual Encounter Profile Question 3 (SEP3) score

  baseline and 12-week follow-up visit

• Change in Sexual Encounter Profile Question 3 (SEP3) score

  baseline and 24-week follow-up visit

Study Arms (2)

LiST + 5mg Tadalafil Group

ACTIVE COMPARATOR

All patients will receive shockwave treatment (6 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), twice per week (total of 3 weeks) without treatment interval. Starting at first LiST session and finishing one week after final LiST session, subjects will receive for 4 weeks daily Tadalafil 5mg. Total treatment period = 4 weeks.

Other: DornierAries2 LiST device + 5 mg Tadalafil

LiST+Placebo Group

PLACEBO COMPARATOR

All patients will receive shockwave treatment (6 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), twice per week (total of 3 weeks) without treatment interval. Starting at first LiST session and finishing one week after final LiST session, subjects will receive for 4 weeks daily placebo pill. Total treatment period = 4 weeks.

Other: DornierAries2 LiST device + Placebo Pill

Interventions

DornierAries2 LiST device + 5 mg Tadalafil OTHER

All patients will receive shockwave treatment (6 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), twice per week (total of 3 weeks) without treatment interval. Starting at first LiST session and finishing one week after final LiST session, subjects will receive for 4 weeks daily Tadalafil 5mg. Total treatment period = 4 weeks

LiST + 5mg Tadalafil Group

DornierAries2 LiST device + Placebo Pill OTHER

All patients will receive shockwave treatment (6 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), twice per week (total of 3 weeks) without treatment interval. Starting at first LiST session and finishing one week after final LiST session, subjects will receive for 4 weeks daily Placebo pills. Total treatment period = 4 weeks.

LiST+Placebo Group

Eligibility Criteria

• Age: 40 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 Erectile Dysfunction for at least 6 months.
• At Screening, diagnosed as Vasculogenic erectile dysfunction based on sexual history
• PDE5i users and report some or good response to PDE5i. Last reported PDE5i use must be within 30 days of Screening Visit.
• Agree to suspend all other ED therapies, except the assigned study treatments, for the duration of the study.
• Agree to attempt sexual intercourse at least 4 times during the last 4 weeks prior to Visit 2/Randomization, 1-month Follow Up, 3-month Follow-Up and 6-month Follow-Up without being under the influence of alcohol or recreational drugs. Agree to document the outcome using the Sexual Encounter Profile (SEP) diary.
• IIEF-EF score 17-25 at Visit 2 (after PDE5i washout)
• At Visit 2 (after PDE5i washout), SEP Q2, "Were you able to insert your penis into your partner's vagina?" answered "YES" 50% - 100% of the time.
• At Visit 2, SEP Q3, "Did your erection last long enough for you to have successful intercourse?" answered "YES" \< 100% of the time.

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 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.
• ED due primarily to psychogenic factors.
• Peyronie's Disease or penile curvature that negatively influences sexual activity.
• Patients with cardiac or non-cardiac electrical devices implanted.
• Open wounds, or any anatomical or neurological abnormalities in the treatment area.
• Uncontrolled diabetes mellitus with glucose \>200 mg/dL (once or more times/week during the last month prior to recruitment, or during screening blood test).
• Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's Disease.
• Refusal to suspend alternative 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.

Sponsors & Collaborators

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

Study Sites (1)

G.Gennimatas Hospital

Thessaloniki, 54621, Greece

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Dimitrios Hatzichristou, Prof.

  Institute for the Study of Urological Diseases, Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: August 28, 2018
• Primary Completion: January 15, 2021
• Study Completion: April 16, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

GR (1)