| Abstract |
Aim: To evaluate the efficacy of low density shockwave therapy (LiSWT) for the treatment of vasculogenic erectile dysfunction (ED) and compare its efficacy with that of phosphodiesterase type 5 (PDE5i) inhibitors. For this purpose and within the concept of this PhD thesis, three prospective studies with similar design were carried out. In all the studies evaluation of response to treatment was done both subjectively using patient questionnaires (IIEF, SEP) and objectively using color Doppler ultrasound of the penis (triplex US). The treatment protocol followed in study # 1 was adopted from the original pilot study of LiSWT for ED. There had been no scientific evidence to support that this is the optimal protocol for LiSWT treatment and there are no data on the safety and efficacy of repeat treatment. Study # 2 evaluated the efficacy and safety of different treatment protocols (6 sessions versus 12 sessions, once or twice a week). In study #3 we evaluated the efficacy and safety of repeat treatment for patients already treated with LiSWT in study # 2.
Material and methods: Study #1 was a double-blind, randomized, sham-controlled study. Initially, in an open label study, PDE5i were administered at the maximum dose to assess the degree of response to treatment. Responders to PDE-5i followed a four-week period of drug discontinuation (“washout” period) prior to randomization. A total of 46 patients were randomized; 30 patients received active treatment with LiSWT while 16 patients received sham treatment. Both prior to treatment initiation and at 3 months after the last session all patients underwent penile Triplex US performed by the same examiner. Patients completed the IIEF questionnaire at baseline and at months 1,3,6 and 12 (FU) after the last session. Following the same study design, 42 patients were randomized in study # 2, 21 in group A and 21 in group B. Group A patients were treated once weekly while group B patients were treated twice weekly for 6 weeks (6 and 12 sessions respectively). All patients were subjected to penile triplex US, performed by the same examiner, at baseline and at 3 months following the last session. Patients completed the IIEF questionnaire at baseline and at months 1, 3 and 6 after the last session. A total of 36 patients, 18 from group A and 18 from group B of study #2 who completed the 6-month follow-up without achieving normal erectile function
(IIEF>25) were enrolled in study #3 and received 6 additional sessions of LiSWT (twice a week for group A, once a week for group B). All were subjected to penile triplex US performed by the same examiner at 3 months after the last session and the results were compared with the original Triplex of study #2. Patients completed the IIEF questionnaire at baseline and also at months 1,3 and 6.
Results: In study#1 a greater improvement for the active therapy group, assessed with IIEF-ED, was seen. Comparison of the two groups was done based on the mean IIEF-ED score with the difference becoming statistically significant after 3 months of follow-up (p = .02) and remaining significant at months 6,9 and 12 (p <.01). The mean change in PSV for the active treatment group was 4.5 cm/sec versus 0.6 cm/sec for the sham treatment group (p <.001). For both the active and sham treatment groups, IIEF-ED was statistically significantly higher with PDE5i and this effect was maintained in all FUs (p <.05). In study #2, based on the IIEF-ED score, both groups showed a statistically significantly improvement compared to baseline at 1, 3 and 6 months following the last session (p <0.001). Comparison of the two groups, using the IIEF-ED mean values, showed a trend towards better improvement for Group B without however becoming statistically significant (p<.05). PSV increased statistically significantly in both treatment groups after treatment (p <0.001). At 3 months FU, the mean PSV in group B (35.4 cm/sec) was higher than in group A (33.4 cm/sec) but the difference was not statistically significant (p=0.06). For both groups, the IIEF-ED was statistically significantly higher with the use of PDE5i and this effect was maintained in all FUs (p<0.05). In study #3, after 6 additional therapies, both group A and group B patients showed further improvement (p <0.001 and p <0.003 respectively). Comparison of the two groups using the mean IIEF-ED values did not show any statistically significant difference (p <.05). The mean PSV change for group A was 1.96 cm/sec versus 0.13 cm/sec for group B (p = 0.082). For group A, IIEF-ED was statistically significantly higher with the use of PDE5i, and this effect was maintained in all FUs (p <0,05). For group B, IIEF-ED was higher, but not statistically significant, at 3 and 6 months after the last session (p> 0.5). No side effects were observed in any of the studies.
Conclusions: LiSWT appears to be an effective and safe option for the treatment of vasculogenic erectile dysfunction by using standard and alternative protocols. It can be safely repeated in patients who have already undergone the same treatment resulting in
further improvement. The effect is dose-dependent and after 18 sessions it approximates the efficacy of PDE5i. The results of this thesis give more flexibility to the urologist to determine a treatment plan depending on the severity of the problem and the patient's preferences.
|
Search
