In a nutshell
This study evaluated the effectiveness of combining low-intensity extracorporeal shock wave therapy (Li-ESWT) with a vacuum erectile device (VED) for the treatment of patients with diabetes mellitus (DM) and erectile dysfunction (ED) who were unresponsive to phosphodiesterase-5 (PDE5) inhibitors. The data showed that Li-ESWT combined with VED was more effective than Li-ESWT or VED therapy alone for the treatment of these patients.
Erectile dysfunction (ED) consists of the inability to get and keep an erection firm enough for sexual intercourse. Around 50% of men with diabetes experience ED. This has a negative impact on the quality of life of men. The standard primary treatment is with phosphodiesterase-5 (PDE5) inhibitors. PDE5 inhibitor such as tadalafil (Cialis) has been shown to improve ED symptoms by increasing the blood flow to the penis and helping to maintain an erection. However, a significant number of these patients still do not manage to have satisfactory intercourse despite treatment with these medications.
Li-ESWT has recently been introduced as a new therapeutic approach for treating ED. Li-ESWT allows for an increase in penile blood flow by delivering low-intensity (non-harmful) shock waves to the penis. These are believed to stimulate the formation of new blood vessels, which is important in achieving an erection. Li-ESWT is an alternative treatment option for men who do not respond to or tolerate, drug therapy with PDE5 inhibitors. Another ED therapy is VED. VED involves an external pump with a band on it that a patient with ED can use to get and maintain an erection.
Both therapies have been shown to help patients with ED that does not respond to medication. However, the effectiveness of combining Li-ESWT with VED for the treatment of patients with diabetes and ED unresponsive to PDE5 inhibitors is still unknown.
Methods & findings
This study involved 100 patients with DM and moderate ED. Patients were randomly divided into 3 groups. Group 1 included 34 patients who received VED only. Group 2 included 33 patients who received Li-ESWT alone. Group 3 included 33 patients who received Li-ESWT plus VED. The patients were followed up at 4, 8, and 12 weeks after the end of treatment. Erectile function was evaluated through a standardized International Index of Erectile Function domain (IIEF-EF) questionnaire.
After 12 weeks of follow-up, the average IIEF scores measuring erectile function significantly improved in 66.7% of the patients in group 3 compared to 36.4% of the patients in group 2 and 17.6% of the patients in group 1.
After 8 weeks of follow-up, the average IIEF scores improved in 51.5% of the patients in group 3 compared to 39.4% of the patients in group 2 and 14.7% of the patients in group 1.
After 4 weeks of follow-up, the average IIEF scores improved in 36.4% of the patients in group 3 compared to 36.4% of the patients in group 2 and 14.7% of the patients in group 1.
The bottom line
This study concluded that Li-ESWT combined with VED was more effective than Li-ESWT or VED therapy alone for the treatment of patients with diabetes and moderate ED who were unresponsive to PDE5 inhibitors.
The fine print
The sample size was very small. The follow-up time was too short. The study had different types and dosages of PDE5 inhibitor drugs and anti-diabetic drugs used in different individuals during enrollment and follow-up, which might affect the conclusions.
Published By :
Frontiers in Endocrinology
Original Title :
The Efficacy of Li-ESWT Combined With VED in Diabetic ED Patients Unresponsive to PDE5is: A Single-Center, Randomized Clinical Trial.