Low-intensity Shockwaves Therapy for the Treatment of Patients With Moderate Vasculogenic Erectile Dysfunction

NCT03518983 | Completed

• 1 other identifier: 5142/2-4-18
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind, sham-controlled randomized, 2 parallel arms, clinical trial with a 12-month recruitment period. All patients will be PDE5I users/responders. After 1 month wash-out period, ED patients will be screened, in order to randomize 70 men with vasculogenic ED.Patients will be randomized in 2 groups (35 subjects in each group) to receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session), twice a week (total of 6 weeks) either at energy level 7 or at sham-control , without treatment interval. The IIEF-ED domain will be evaluated at Visit 1 and, consequently, at baseline and all follow up visits together with the SEP diaries.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• The difference between the 2 groups in the percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF

  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(EF scores 11-16) at baseline

  at 3 month follow up visit

Secondary Outcomes (3)

• The difference between the 2 groups in the change of the EF domain score of the IIEF

  baseline and 3 month follow up visit.

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

  baseline and 3 month follow up visit.

• Number of patients with treatment related adverse events

  18 weeks

Study Arms (2)

Sham Group

SHAM COMPARATOR

The subjects of this group will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session), twice a week (total of 6 weeks) by the sham probe.

Device: Dornier Aries2 device (sham probe)

Active Group

ACTIVE COMPARATOR

The subjects of this group will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session), twice a week (total of 6 weeks) at energy level 7.

Device: Dornier Aries2 device

Interventions

Dornier Aries2 device DEVICE

The Dornier Aries2 device and will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft and the 2 crura(two sites).

Active Group

Dornier Aries2 device (sham probe) DEVICE

The Dornier Aries2 device and will be used for the purpose of the study but the active probe will be replaced by an identical sham probe.

Sham 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 ED therapy 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 and 3-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.
• At Visit 2 (after PDE5i washout), SEP Q2, "Were you able to insert your penis into your partner's vagina?" answered "YES" 25% - 100% of the time.
• At Visit 2, SEP Q3, "Did your erection last long enough for you to have successful intercourse?" answered "YES" 0% - 50% of the time.
• At Visit 2, IIEF-EF score 11 - 16.
• \. At Visit 2, IIEF Q3 score 2 - 5. 14. At Visit 2, IIEF Q4 score 1 - 3.

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 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.

Sponsors & Collaborators

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

Study Sites (1)

G.Gennimatas Hospital

Thessaloniki, 54621, Greece

Location

Related Publications (2)

• Kalyvianakis D, Memmos E, Mykoniatis I, Kapoteli P, Memmos D, Hatzichristou D. Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment. J Sex Med. 2018 Mar;15(3):334-345. doi: 10.1016/j.jsxm.2018.01.003. Epub 2018 Feb 1.

  PMID: 29396020 BACKGROUND

• Kalyvianakis D, Hatzichristou D. Low-Intensity Shockwave Therapy Improves Hemodynamic Parameters in Patients With Vasculogenic Erectile Dysfunction: A Triplex Ultrasonography-Based Sham-Controlled Trial. J Sex Med. 2017 Jul;14(7):891-897. doi: 10.1016/j.jsxm.2017.05.012.

  PMID: 28673433 BACKGROUND

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

• Dimitris Hatzichristou, Prof.

  G.Gennimatas General Hospital, Thessaloniki,Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, Institute for the Study of Urological Diseases Thessaloniki, Greece

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 8, 2018
• Study Start: May 22, 2018
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)