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

NCT03642366 | Unknown

• 1 other identifier: 10673/2018
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction

Keywords

Low Intensity Shockwave Therapy

Outcome Measures

Primary Outcomes (1)

• The difference between the groups in the change of the Erectile Function (EF) domain score of the International Index of Erectile (IIEF)

  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)

• The difference between the groups in the change of the Erectile Function (EF) domain score of the International Index of Erectile (IIEF)

  baseline and 4 week follow up visit

• The difference between the groups in the change of the Erectile Function (EF) domain score of the International Index of Erectile (IIEF)

  baseline and 16 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 16-week follow up visit

Study Arms (3)

Active Arm 1

ACTIVE COMPARATOR

Other: Dornier Aries2 LiST Device + 5mg Tadalafil (1)

Active Arm 2

ACTIVE COMPARATOR

Other: Dornier Aries2 LiST Device + 5mg Tadalafil (2)

Sham Arm

SHAM COMPARATOR

Other: Sham LiST Device + 5mg Tadalafil

Interventions

Dornier Aries2 LiST Device + 5mg Tadalafil (1) OTHER

Patients will 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. 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.

Active Arm 1

Dornier Aries2 LiST Device + 5mg Tadalafil (2) OTHER

Patients will 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. 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.

Active Arm 2

Sham LiST Device + 5mg Tadalafil OTHER

Patients will receive sham shockwave treatment (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7)using a sham probe identical to active probes, three times a week (total of 4 weeks) without treatment interval. 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.

Sham Arm

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.
• 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.

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

RECRUITING

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

Central Study Contacts

Paraskevi Kapoteli

CONTACT

2310963105; pkapotel@auth.gr

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 27, 2018
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

GR (1)