Clinical trial NCT03596047: Radial Shockwave Therapy for Erectile Dysfunction
Official title: Clinical Trial With Random Assignment to Evaluate the Efficacy and Safety of Radial Waves for the Treatment of Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Keywords: radial wave therapy
Lead sponsor: Boston Medical Group
Sponsor class: INDUSTRY
First posted: 2018-07-23
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind clinical trial.
Primary purpose: TREATMENT

Brief summary: Objective: To evaluate the efficacy and safety of radial shock waves for the treatment of erectile dysfunction \[ED\].

Patients and methods: Randomized, double-blind clinical trial. The study will include patients of legal age with diagnosis of ED and score on the International Index of Erectile Function \[IIEF-EF\] scale between 11 and 21 points, who voluntarily decide to participate and sign the informed consent. Patients with bladder cancer, prostate cancer or active colon, ED of psychological origin, any psychiatric disorder, spinal cord injury, clinical suspicion of hypogonadism (score on the Aging Males' Symptoms scale greater than 36), infections or active lesions of the penis or pubic area, ED secondary to treatment with medications (antiandrogenic therapy, use of corticosteroids, anti-Parkinson's, antipsychotics), radical prostatectomy or other radical pelvic surgery, history of pelvic radiotherapy, penile implantation, or endocrine diseases that occur with ED (acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgenic deficiency), sickle cell anemia, and anticoagulated patients will be excluded.

Patients will be randomly assigned to one of the following treatment arms:

* Arm 1 (Standard treatment (oral sildenafil) + Radial wave therapy)
* Arm 2 (Standard treatment (oral sildenafil) + Placebo therapy)

Measurements will be made of the Erection Hardness Score \[EHS\] and IIEF-EF scale scores, of the use of medication and of the possible adverse events of the therapy, at the beginning and end of the treatment, and one month after the therapies are finished.

Detailed description: Background: Radial shock waves are an effective therapy for the management of various problems at the muscular and joint level, thanks to the effect it has on the activation of microcirculation. The effect of these waves on patients with erectile dysfunction is currently unknown; however, it is considered possible to help recovery in patients with vascular origin dysfunction by increasing microcirculation blood flow in this area.

Objective: To evaluate the efficacy and safety of radial shock waves for the treatment of erectile dysfunction.

Patients and methods: Randomized, double-blind clinical trial. The study will include patients of legal age with diagnosis of ED and score on the IIEF-EF scale between 11 and 21 points, who voluntarily decide to participate and sign the informed consent. Patients with bladder cancer, prostate cancer or active colon, ED of psychological origin, any psychiatric disorder, spinal cord injury, clinical suspicion of hypogonadism (AMS greater than 36), infections or active lesions of the penis or pubic area, ED secondary to treatment with medications (antiandrogenic therapy, use of corticosteroids, anti-Parkinson's, antipsychotics), radical prostatectomy or other radical pelvic surgery, history of pelvic radiotherapy, penile implantation, or endocrine diseases that occur with ED (acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgenic deficiency), sickle cell anemia, and anticoagulated patients will be excluded.

Patients will be randomly assigned to one of the following treatment arms:

* Arm 1 (Standard treatment (oral sildenafil) + Radial wave therapy): Sildenafil according to the degree of patient involvement + 6 sessions of radial waves. A weekly session of radial waves will be applied with the following parameters: 6000 pulses at 1.5-2.6 bar (depending on patient tolerance), with a frequency of 17Hz, the frequency should increase to 22HZ the first 500 impulses to create mild anesthesia in the area; in all radial wave sessions, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area.
* Arm 2 (Standard treatment (oral sildenafil) + Placebo therapy): Sildenafil according to the patient's degree of affectation + 6 sessions of placebo therapy. There will be a weekly session of placebo wave therapy, using the respective device to prevent the patient from receiving the radial wave. The same parameters of the "real" therapy will be used: 6000 pulses at 2.6 bar, with a frequency of 17 Hz; in all radial wave sessions, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area.

Measurements will be made of the EHS and IIEF-EF scale scores, of the use of medication and of the possible adverse events of the therapy, at the beginning and end of the treatment, and one month after the therapies are finished.

Eligibility criteria: Inclusion Criteria:

* Men older than 18 years
* Erectile dysfunction present more for more than 3 months in more than 50% of intercourse.
* IIEF-EF score between 11 and 21.
* Patient who agrees to enter the study through the signing of an informed consent.

Exclusion Criteria:

* EHS score of 4
* Bladder, prostate or colon cancer.
* ED of psychological origin.
* Patients with spinal cord injury.
* Patients with anticoagulant use.
* Patients with sickle cell anemia.
* Patients with clinical suspicion of hypogonadism (AMS greater than 36, Annex 1).
* Patients with infections or active lesions of the penis or pubic area.
* Patients with ED secondary to drug treatment (antiandrogenic therapy, antidepressants, use of corticosteroids, antiparkinsonians, antipsychotics).
* Radical prostatectomy or other radical pelvic surgery.
* Antecedents of pelvic radiotherapy.
* Patients with penile implant.
* Endocrine diseases that occur with ED: acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgenic deficiency.
* Patients with neurological diseases (Parkinson's, CVD, dementia of any origin)

Primary outcomes:
measure: Change IIEF-EF Score
timeFrame: 6 weeks (The end of the treatment)
Secondary outcomes:
measure: IIEF-EF Score After One Month of Follow-up
timeFrame: Month 1 of follow-up (Week 10)
measure: Erection Hardness Score (EHS)
timeFrame: 6 weeks (At the end of treatment)
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Boston Medical Group Colombia
state: Cundinamarca
Study officials:
affiliation: Boston Medicval Group
name: Jose Saffon, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sandoval-Salinas C, Saffon JP, Martinez JM, Corredor HA, Gallego A. Are Radial Pressure Waves Effective for the Treatment of Moderate or Mild to Moderate Erectile Dysfunction? A Randomized Sham Therapy Controlled Clinical Trial. J Sex Med. 2022 May;19(5):738-744. doi: 10.1016/j.jsxm.2022.02.010. Epub 2022 Mar 24.