Clinical trial NCT03308409: Comparative Effectiveness and Safety of Three Protocols Usin Li-ESWT for Erectile Dysfunction
Official title: Clinical Randomized Multicentric Trial to Evaluate the Comparative Effectiveness and Safety of Three Protocols Using Low-intensity Shock Waves for the Treatment of Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: Boston Medical Group
Sponsor class: INDUSTRY
First posted: 2017-10-12
Enrollment: 277
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who met the selection criteria were randomly assigned to one of three groups: weekly protocol, monthly protocol, or booster protocol, in a 1:1:1 ratio.
Primary purpose: TREATMENT

Brief summary: The patients with primary erectile dysfunction (IIEF-EF \<26 points), will be randomly assigned to three shockwave treatment protocols: Protocol 1 six sessions, one per week; Protocol 2, six initial sessions, one per week, followed by monthly maintenance sessions (every 4 weeks) for five months; Protocol 3, six monthly sessions. The EHS and IIEF-EF scores will be compared as well as the possible adverse events from the therapy upon beginning and completing the treatment and at the 3-month and 6-month follow-ups. Self-esteem and quality of life will also be evaluated using the SEAR scale.


Eligibility criteria: Inclusion Criteria:

* Men over 18 years of age
* Presence of ED for more than 3 months in over 50% of sexual intercourses.
* Baseline ED domain score under 26 on the IIEF-15 EF domain.
* Patient agrees to participate in the trial by providing signed informed consent.

Exclusion Criteria:

* EHS score of 4.
* Patients with an INR over 3.
* Patients with sickle-cell anemia.
* Patients with clinical suspicion of hypogonadism (AMS over 36).
* Endocrine diseases that present with ED, such as acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgen deficiency.
* Active vesicular, prostrate or colon cancer.
* Radical prostatectomy or other radical pelvic surgery.
* History of pelvic radiation therapy.
* Patients with ED of psychological origin.
* Spinal cord injury or other neurological diseases associated with ED.
* Anatomical penile dysfunction, penile implant.
* Patients with active infections or lesions on the penis or pubic area.
* Patients with ED secondary to drug therapy (antiandrogen therapy, alpha blockers for BPH, use of corticosteroids, medication for Parkinson's disease, antipsychotics).
* Abuse of psychoactive substances.

Primary outcomes:
measure: IIEF-EF score 6 months after completing the treatment
timeFrame: 6 month follow-ups
Secondary outcomes:
measure: Erection Hardness Score
timeFrame: 3-month and 6-month follow-ups
measure: Clinical improvement
timeFrame: 6-month follow-ups
measure: Number of satisfactory relations
timeFrame: 3-month and 6-month follow-ups
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Boston Medical Group Colombia
state: Cundinamarca
city: Mexico City
country: Mexico
facility: Boston Medical Group
Study officials:
References: