A Study to Evaluate the Efficacy of Low Intensity Shockwave Therapy via MoreNova in the Treatment of Erectile Dysfunction (ED).
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-001246
NCT ID: NCT04136288
Sponsor Protocol Number: 18-001246
About this study
The purpose of this study is to assess and evaluate the efficacy of the use of MoreNova shockwave therapy in individuals diagnosed with Erectile Dysfunction (ED) by a change in evidence based imagining via Color Duplex Doppler ultrasound (CDDU), and by patient reported questionnaires.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- The patient must have given his informed and signed written consent
- The patient is a male
- Between 40 to and including 55 years of age
- The patient has ED for longer than 1 year but less than 5 years.
- The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
- SHIM- EF Domain score of 17-20
- Evidence Based Criteria: Doppler Clinical Exam ( PSV < 35 cm/sec, but > 25 cm/sec and RI >0.8)
Exclusion Criteria:
- The patient is participating in another study that may interfere with the results or conclusions of this study
- History of radical prostatectomy or extensive pelvic surgery
- Past radiation therapy of the pelvic region within 12 months prior to enrollment
- Recovering from cancer within 12 months prior to enrollment
- Neurological disease which effects erectile function
- Psychiatric disease which effects erectile function
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Gregory Broderick, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available