Hypothesis / aims of study
Erectile dysfunction(ED) as a common disease in men, the effects of the treatments so far are not perfect, so it is important to complete the new methods. The effectiveness of low-intensity pulsed ultrasound (LIPUS) and biofeedback electric stimulation for pelvic on ED improvement needs further study, in addition, it is unclear whether these treatments have a synergistic effect in treating ED.
Study design, materials and methods
In this randomized, open-label, parallel-group, non-inferiority clinical trial conducted at West China Fourth Hospital, 25 patients were enrolled in the LIPUS group and 20 patients in the LIPUS combined with biofeedback electric stimulation group. The efficacy and safety of these treatments were evaluated using the International Index of Erectile Function-5 (IIEF-5), Erectile Hardness Score (EHS), and Erection Satisfaction Score (ESS) after the fourth and eighth treatment.
Results
After the eighth treatment, the IIEF-5, EHS, and morning erection scores significantly increased in the LIPUS group (p<0.05). In the LIPUS combined with biofeedback electric stimulation group, the IIEF-5 and EHS scores significantly increased after the fourth treatment, and the morning erection score and sexual stimulation erection score significantly increased after the eighth treatment(p<0.05). Though there was no significant difference between the two groups at the given treatment(p>0.05), combination treatment advanced the effective time of ED improvement.
Interpretation of results
1. A total of 97 patients were screened from June 17, 2019, to August 15, 2022. 45 patients were randomized. The LIPUS group has 25 patients, the LIPUS combined with biofeedback electric stimulation group has 20 patients(Figure 1). Demographic data and six tests for sex hormones of each group are shown in Table 1. In the LIPUS group and LIPUS combined with biofeedback electric stimulation group, the mean age of the patients were 38.24±9.05 and 35.20±8.50(P=0.256), and the median age were 34.00 and 33.50. Testosterone(T), prolactin(PRL), luteinizing hormone(LH), follicle-stimulating hormone(FSH), estradiol(E2), and progesterone(P) in the two groups no significant differences(P=0.933, P=0.354, P=0.601, P=0.067, P=0.915, P=0.317,respectively).
2. Comparison of outcomes after fourth treatment
Comparisons of outcomes after four times treatments are shown in Table 2. In the LIPUS group, IIEF5 scores and EHS scores increased after four times treatments ,but there are no significant differences between the first time and fourth time treatment(P=0.126 and P=0.264, respectively ). Morning erection scores and sexual stimulation scores has no differences after four times treatments(P=0.295 and P=0.129, respectively). In the LIPUS combined with biofeedback electric stimulation group, IIEF5 scores and EHS scores increased after four times treatments with significant difference (P=0.020 and P=0.012, respectively), sexual stimulation scores increased and morning erection scores has no difference after four times treatments(P=0.072 and P=0.663, respectively). The masturbation reaction scores were not significant differences between the three times treatments in both group(P=0.324 and P=0.109, respectively).
3. Comparison of outcomes after eighth treatment
Comparisons of outcomes after eight times treatments are shown in Table 2. In the LIPUS group, IIEF5 scores and EHS scores increased after eight times treatments(P=0.004 and P=0.011, respectively ). Morning erection scores and sexual stimulation scores increased after eight treatments in the LIPUS group(P=0.012 and P=0.060, respectively). In the LIPUS combined with biofeedback electric stimulation group, IIEF5 scores and EHS scores increased after eight times treatments (P<0.001 and P<0.001, respectively), morning erection scores and sexual stimulation scores increased after eight times treatments(P=0.028 and P=0.002, respectively).