Efficacy & Safety of a 2nd Series of Low Intensity Shock Waves for ED on Partial Responders to First Treatment
Recruitment status was: Not yet recruiting
|Erectile Dysfunction||Device: Low Intensity Extracorporeal Shock waves (Cardiospec 1000)||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of a Second Series of Low Intensity Extracorporeal Shock Wave Therapy (LI-ESWT) Treatment for Erectile Dysfunction Patients Who Were Partial Responders to the Initial Treatment.|
- IIEF-ED Domain score [ Time Frame: 3 months ]Severe ED (6≤IIEF-ED Domain score≤10): an increase of 7 points and above; Moderate ED (11≤IIEF-ED Domain score≤16): an increase of 5 points and above; Mild ED (17≤IIEF-ED Domain score≤25): an increase of 2 points and above.
- Rigidity Score Questionaire [ Time Frame: 3 months ]An increase of at least 1 point is considered as a treatment success.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
|Experimental: Open label||
Device: Low Intensity Extracorporeal Shock waves (Cardiospec 1000)
We will apply the cardiospec 1000 unit for LI-ESWL in the penile and inguinal areas, 300 shocks per area, total of 1500 shocks. Full description of treatment series can be seen in the detailed protocol.
Other Name: Cardiospec 1000
The patients will be selected out of the patients with Erectile Dysfunction who received Low intensity shock waves and Were Partial Responders to the treatment.
At the first meeting the patient will receive a full explanation of the study, the potential efficacy and risks. After that the patient will be asked to sign an informed consent form. The patient's general medical condition and any problems related to sexual dysfunction are already known from the previous study he was participating. Also the patient's sexual function is already known by sexual function questionnaires that were filled out in previous study. The criteria for inclusion and exclusion will be reviewed, as well as physical examination. Then shall the patient obtain reporting sexual encounter diaries (SEP) and will be asked to avoid using PDE5i's for a month (washout), if he did not do so of some reason after ending the previous study, then it would be the first visit (Visit 1). At visit 1 The patient will be questioning the sexual function questionnaires without PDE5i's and will pass examination performance Endothelial - FMD, the test takes about 10 minutes, it is not an invasive test (not involved in inserting an instrument or any medication) and is painless. The patient may be asked to also undergo Doppler ultrasound. At the end of visit 1 the patient will begin Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments). Four weeks after the treatment series ends the patient will come for another visit and will be asked to fill in questionnaires and perform the FMD and/or Doppler ultrasound test again. The patient's ED condition will be followed up for a long term after the end of his participation in the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601262
|Contact: Yoram Vardi Vardi, Prof. MDfirstname.lastname@example.org|
|Contact: Ilan Gruenwald, MDemail@example.com|
|Rambam Health Care Campus||Not yet recruiting|
|Contact: Ilan Gruenwald, MD 00972-4-8542882 firstname.lastname@example.org|
|Contact: Yoram Vardi, Prof. MD 00972-4-8542819 email@example.com|
|Principal Investigator: Ilan Gruenwald, MD|
|Sub-Investigator: Yoram Vardi, Prof.MD|
|Sub-Investigator: Boaz Appel, MD|
|Sub-Investigator: Suliman Nassar, MD|
|Sub-Investigator: Yaron Ofer, MD|
|Sub-Investigator: Omar Massarwa, RN BA|
|Sub-Investigator: Ezra Gerber, RN BA|
|Sub-Investigator: Arik Shechter, MD|
|Principal Investigator:||Ilan Gruenwald, MD||Rambam Health Care Campus|
|Study Director:||Yoram Vardi, Prof. MD||Rambam Health Care Campus|