Low-intensity Shockwaves Therapy + Tadalafil 5mg for the Treatment of Severe Erectile Dysfunction

STATUS

Recruiting
End date

Dec 12, 2022
participants needed

51
sponsor

Institute for the Study of Urological Diseases, Greece

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Updated on 12 May 2022

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probe

active treatment

tadalafil

recreational drugs

vasculogenic erectile dysfunction

Summary

This is a randomized, double-blind, sham-controlled, 3 parallel arms, clinical trial. All patients will be PDE5I users or ex-users. After 1 month wash-out period, ED patients will be screened, in order to randomize 51 men with vasculogenic ED. Patients will be randomized in 3 groups (17 subjects in each group) to receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), three times a week (total of 4 weeks) without treatment interval. One group will be sham-control at energy level 7 whereas 2 groups will receive active treatment.Three identical standard probes (probes A, B, C) will be used for the study, 2 of them active and one sham. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks. The IIEF-ED domain will be evaluated at Visit 1 and, consequently, at baseline and all follow up visits together with the SEP diaries.

Details

Condition	Erectile Dysfunction
Treatment	Dornier Aries2 LiST Device + 5mg Tadalafil (1), Dornier Aries2 LiST Device + 5mg Tadalafil (2), Sham LiST Device + 5mg Tadalafil
Clinical Study Identifier	NCT03642366
Sponsor	Institute for the Study of Urological Diseases, Greece
Last Modified on	12 May 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
	Partial response to highest dose of PDE5i
	Agree to suspend all other ED therapies, except the assigned study treatments, for the duration of the study
	Agree to attempt sexual intercourse and document the outcome using the Sexual Encounter Profile (SEP) at least 4 times for the last 4 weeks prior to Visit 2/Randomization, 1 month Follow Up, 3 month Follow Up and 4 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-ED score 1-10 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" 0 - 50% of the time
	At Visit 2, SEP Q3, "Did your erection last long enough for you to have successful intercourse?" answered "YES" 0 - 25% of the time
Exclusion Criteria
	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 wound 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 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
	Known allergy to ultrasound gel. 18,. 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 e.g., Citalopram (Celexa), Escitalopram (Lexapro, Cipralex), Paroxetine (Paxil, Seroxat), Fluoxetine (Prozac), Fluvoxamine (Luvox, Faverin),Sertraline (Zoloft, Lustral), Clonazepam (Klonopin), Alprazolam (Xanax), Aripiprazole (Ambilify), Clozapine (Clozaril), Risperidone (Risperdal), Quetiapine (Seroquel), Olanzapine (Zyprexa) are also excluded
	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
	History of adverse events in response to tadalafil, which would prevent patient compliance to the study protocol

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Low-intensity Shockwaves Therapy + Tadalafil 5mg for the Treatment of Severe Erectile Dysfunction