Ignite Creation Date:
2024-05-06 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03596047
Status:
COMPLETED
Last Update Posted:
2019-12-20
First Post:
2018-06-13
Brief Title:
Radial Shockwave Therapy for Erectile Dysfunction
Sponsor:
Boston Medical Group
Organization:
Boston Medical Group
Study Overview
Official Title:
Clinical Trial With Random Assignment to Evaluate the Efficacy and Safety of Radial Waves for the Treatment of Erectile Dysfunction
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-Parkinsons antipsychotics radical prostatectomy or other radical pelvic surgery history of pelvic radiotherapy penile implantation or endocrine diseases that occur with ED acromegaly gigantism Addisons 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
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-Parkinsons antipsychotics radical prostatectomy or other radical pelvic surgery history of pelvic radiotherapy penile implantation or endocrine diseases that occur with ED acromegaly gigantism Addisons 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-Parkinsons antipsychotics radical prostatectomy or other radical pelvic surgery history of pelvic radiotherapy penile implantation or endocrine diseases that occur with ED acromegaly gigantism Addisons 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 15-26 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 patients 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 26 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
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-Parkinsons antipsychotics radical prostatectomy or other radical pelvic surgery history of pelvic radiotherapy penile implantation or endocrine diseases that occur with ED acromegaly gigantism Addisons 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 15-26 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 patients 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 26 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None