Low-intensity Shockwaves Therapy: Validation of an Evidence Based Protocol in a Randomized, Sham-controlled Trial for the Treatment of Patients With Moderate Vasculogenic Erectile Dysfunction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Erectile Dysfunction
- Sponsor
- Institute for the Study of Urological Diseases, Greece
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Dimitrios Hatzichristou
President, Institute for the Study of Urological Diseases Thessaloniki, Greece
Institute for the Study of Urological Diseases, Greece
Eligibility Criteria
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
- •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.
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.
Outcomes
Primary Outcomes
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
Time Frame: at 3 month follow up visit
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
Secondary Outcomes
- The difference between the 2 groups in the change of the EF domain score of the IIEF(baseline and 3 month follow up visit.)
- Number of patients with treatment related adverse events(18 weeks)
- Change in Sexual Encounter Profile Question 3 (SEP3) score(baseline and 3 month follow up visit.)