Type of Study Randomized, experimental, non-inferiority clinical trial to determine the comparative effectiveness and safety of two protocols used in the treatment of ED with Li-ESWT, for patients seen at the Boston Medical Group's Bogota center. Total duration: 5 weeks.
Doppler measurements of penile arteries will be taken at baseline and 1 month after completing each protocol. If they are eligible they will be invited to participate in the investigation and will be given an informed consent form which explains the objectives of the investigation as well as the risks involved in participating in the Swissdave.
Instead of dangerous chemical compounds, SwissWave Protocol uses pulsed-energy waves to open and repair aging blood vessels and increase blood flow to your penis. Restore Medical Center. In terms of historical information, 4 to 5 individuals are expected to be included Swissaave the study per week. The sound waves repair aged blood vessels, stimulate growth of new blood vessels and remove decades of micro-plaque.
A second measurement of penile blood flow will be taken with doppler echography one month after completing each of the protocols.
The last individual included will be followed up to the sixth month after completion of therapy. Upon completion of the administration of the protocols, EHS and IIEF-5 scores will be measured a second time, as well as any associated adverse effects. Are there any studies?
Men with Erectile Dysfunction — SwissWave Protocol has proven to be a safe and effective drug-free, surgery-free alternative to Viagra and other oral ED medications. The ED grade is scored on a scale of 0 to 25 points, where: is Swiswwave, is moderate, is mild to moderate; is average; and ED does not exist 28 Appendix 2.
These medications only work on half the men who take them and with very dangerous side effects for most who can protocol them. Safety This will be determined according to the presence of adverse events, which will be analyzed upon completion of each therapy and after 1, 3 and 6 months control months. Swisswave does the SwissWave Work? Sample Size The sample size was calculated for non-inferiority, based on the new approach being at least as good as the existing one.
The clinical information will be extracted from this electronic clinical history once all the data from the sample has been collected. The SwissWave is an evidence-based, alternative treatment for erectile dysfunction or ED. The patients will then be ased to one of two arms through the process of selecting a ballot among a group of ballots marked with the protocols and stored in a dark bag.
Ha: No differences exist in the effectiveness of two treatment protocols for the use of Li-ESWT to treat erectile dysfunction, measured by an improvement prrotocol the EHS score one month after completing treatment. The distribution of the shocks will be pulses to the body of the penis and pulses at its base.
Penile blood flow with vasoactive stimuli of prostaglandin VSPmeasured by color echo-doppler. You can read the extensive medical research here.
Investigation Hypothesis Ho: Swisswave exist in the effectiveness of two treatment protocols for the use of Li-ESWT to treat erectile dysfunction, measured by an improvement in the EHS score one month after completing treatment. Who is the SwissWave Therapy for? SwissWave Utilizes high frequency, low intensity sound waves to improve blood flow to the penis. The improvement in blood flow in stronger, harder, and more sustainable erections.
In addition, this has a high sensitivity and specificity for detecting changes in erectile function in response to treatment. If you want to perform your best, and satisfy your lover like you never have before, SwissWave Swlsswave can help!
All the information will be recorded in the electronic clinical history Swissdave already exists at the Boston Medical Group. Protlcol is important to emphasize that no adverse events have been reported to-date by any clinical trial of patients with ED who have been treated with Li-ESWT 12, 14, 19, Follow-up and Loss-to-Follow-up One person involved in the project and a medical supervisor will be responsible for conducting a telephone follow-up of the patients included in the study.
Total duration: 3 weeks.
These patients must meet the eligibility criteria. Contact What is SwissWave Protocol? EHS and IIEF-5 scores will be determined at these consultations, as well as the presence or absence of adverse events related to the therapy. Interventions Each patient will be randomly ased to one of the two arms. This information will be exported to a flat file so it can be read later by a statistical package.
The scores from the EHS and IIEF-5 scales will be measured at baseline, upon completion of each protocol, and 1, 3 and 6 months after completing each protocol. Five questions related to erectile function, orgasmic function, sexual desire, satisfaction with sexual relations and overall satisfaction.