Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply that do not respond to oral therapy (PDE-5 inhibitors).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction

NCT00901056

Erectile Dysfunction

COMPLETED PHASE1/PHASE2

The Effect of Low Intensity Shock Wave Therapy for ED in PDE5i Non Responders

NCT01272297

Erectile Dysfunction

COMPLETED PHASE3

Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction

NCT01274156

Erectile Dysfunction

COMPLETED PHASE3

Efficacy & Safety of a 2nd Series of Low Intensity Shock Waves for ED on Partial Responders to First Treatment

NCT01601262

Erectile Dysfunction

UNKNOWN PHASE3

Low Intensity Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction- 4 Arms

NCT01442077

Erectile Dysfunction

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered directly to the penile tissue using a specially designed shockwave device and probe. Shock wave therapy is applied twice a week for three weeks , then a 3- week interval with no therapy followed by another 3 week period of twice a week shock wave therapy. Before and after sexual function questionnaires and objective measures of erectile function will be performed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Erectile Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo

We use the same probe that induces the same sensation on the penis and the same noise yet no energy

Group Type SHAM_COMPARATOR

Extracorporeal Shockwave Therapy Generator (Vascuspec)

Intervention Type DEVICE

Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.

Shock wave therapy

12 treatment sessions twice a week during 9 weeks with an interim of 3 weeks no treatment

Group Type ACTIVE_COMPARATOR

Low intensity shock wave therapy

Intervention Type DEVICE

Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Extracorporeal Shockwave Therapy Generator (Vascuspec)

Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.

Intervention Type DEVICE

Low intensity shock wave therapy

Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Low intensity shock wave Therapy Extracorporeal Shockwave Therapy Low Intensity Extra Corporal Shock Wave Therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ED of more than 6 months
* Rigidity score \< 3 during PDE5i therapy
* SHIM \<21 during PDE5i therapy
* Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months

Exclusion Criteria

* Prior prostatectomy surgery
* Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
* Clinically significant chronic hematological disease
* Anti-androgens, oral or injectable androgens
* Radiotherapy in pelvic region

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No