Efficacy Of Low-intensity Shock Wave Therapy Research Articles

Low-intensity shockwave therapy improves baseline erectile function: a randomized sham-controlled crossover trial

Abstract Background Low-intensity shockwave therapy for erectile dysfunction is emerging as a promising treatment option. Aim This randomized sham-controlled crossover trial assessed the efficacy of low-intensity shockwave therapy in the treatment of erectile dysfunction. Methods Thirty-three participants with organic erectile dysfunction were enrolled and randomized to shockwave therapy (n = 17) or sham (n = 16). The sham group was allowed to cross over to receive shockwave therapy after 1 month. Outcomes Primary outcomes were the changes in Sexual Health Inventory for Men (SHIM) score and Erection Hardness Score at 1 month following shockwave therapy vs sham, and secondary outcomes were erectile function measurements at 1, 3, and 6 months following shockwave therapy. Results At 1 month, mean SHIM scores were significantly increased in the shockwave therapy arm as compared with the sham arm (+3.0 vs −0.7, P = .024). Participants at 6 months posttreatment (n = 33) showed a mean increase of 5.5 points vs baseline (P < .001), with 20 (54.6%) having an increase ≥5. Of the 25 men with an initial Erection Hardness Score <3, 68% improved to a score ≥3 at 6 months. When compared with baseline, the entire cohort demonstrated significant increases in erectile function outcomes at 1, 3, and 6 months after treatment. Clinical Implications In this randomized sham-controlled crossover trial, we showed that 54.6% of participants with organic erectile dysfunction met the minimal clinically important difference in SHIM scores after treatment with low-intensity shockwave therapy. Strengths and Limitations Strengths of this study include a sham-controlled group that crossed over to treatment. Limitations include a modest sample size at a single institution. Conclusions Low-intensity shockwave therapy improves erectile function in men with erectile dysfunction as compared with sham treatment, which persists even 6 months after treatment. Clinical Trial Registration ClinicalTrials.gov NCT04434352.

Efficacy of low-intensity shockwave therapy with different tadalafil regimens in patients with PDE5 inhibitor-resistant erectile dysfunction: a retrospective cohort study.

Currently, there is a lack of research comparing tadalafil treatment protocols recommended during low-intensity shock wave therapy (LI-SWT) for patients with erectile dysfunction (ED) who are unresponsive to phosphodiesterase type 5 inhibitors (PDE5i). The objective of this study is to compare the efficacy of only LI-SWT versus LI-SWT plus 5mg tadalafil daily versus LI-SWT plus 20mg tadalafil alternate-day in PDE5i -resistant ED. MATERıALS AND METHODS: In this study, a cohort of 105 patients with PDE5i-resistant ED was recruited and divided into three groups labeled as A (only LI-SWT), B (LI-SWT plus 5mg tadalafil daily), and C (LI-SWT plus 20mg tadalafil alternate-day), comprising 27, 42, and 36 patients, respectively. The patients' International Index of Erectile Function-5 (IIEF-5) scores and the Erection Hardness Score (EHS) were evaluated at the baseline, three months and six months following the treatment. After three months post-treatment, the IIEF-5 scores in group A, B, and C increased by 4.1 ± 0.6, 7.3 ± 0.6, and 8.2 ± 0.6, respectively. These improvements were maintained at six months with IIEF-5 scores increasing by 3.7 ± 0.6, 7.3 ± 0.6, and 8.5 ± 0.7 in groups A, B, and C, respectively. At 3 and 6months post-treatment, groups B and C showed significant improvement in IIEF-5 scores and EHS values compared to group A (p < 0.001). The rate of patients with EHS ≥ 3 and IIEF-5 ≥ 17 was significantly higher in groups B and C compared to group A, while there was no significantly different between groups B and C. CONCLUSıON: In patients with PDE5i-resistant ED, PDE5i combined with LI-SWT is superior to LI-SWT monotherapy. The statistical analysis failed to demonstrate any difference between two distinct tadalafil regimens when administered with LI-SWT treatment.

(432) Efficacy of Low-Intensity Shockwave Therapy on Hard Flaccid Syndrome: Initial Report of Three Cases

Abstract Introduction Hard flaccid syndrome (HFS) is characterized by chronic pain in the penis and perineum and firmness or rigidity of the penis even while not erect and may have a devastating impact on patient sexual quality of life. Although this syndrome has been discussed in myriad patient forums, there is no established evidence-based definition nor specific standard established treatment modalities in the literature. Current treatment options may include a combination of medical pain management, pelvic floor physical therapy, biofeedback, and stress reduction. In patients with other chronic pain conditions who fail traditional therapies, low-intensity shock wave therapy (LiSWT) has been increasingly utilized as management with positive response. We report a series of three patients with managed with LiSWT. Objective To report our initial experience of men with HFS managed with LiSWT. Methods Three patients, aged 36, 24, and 20 diagnosed with HFS were treated with LiSWT for a course of six sessions. In each session, LiSWT settings were: energy flux density of 0.13 mJ/mm2 and frequency of 3 Hz. While penis was held in stretched position, 600 shocks were delivered to each of the dorsum, left, ventral, and right aspects of penis along the shaft. The scrotum was then held up, and 600 shocks were delivered to each of the right and left crural areas, adding up to 3600 total number of shocks that were allocated evenly. All patients answered a questionnaire to assess improvement in symptoms after completion of the treatment sessions (Table 1). Results All patients reported initially alleviated symptoms after 3 treatment sessions, particularly with respect to penile rigidity in the flaccid state. Patient 1 elected for a combination of LiSWT and tadalafil. 5 months after treatment completion, Patient 1 has had complete resolution of HFS symptoms. Patient 2 had no response with tadalfil alone before he elected for LiSWT only, and patient 3 opted for LiSWT alone. After each LiSWT session, patient 2 reported relieved symptoms for 3-4 days, while patient 3 reported significant improvement lasting for 24 hours. Both patients 2 and 3 reported gradually returning to their pre-treatment baseline in 5 months’ follow-up. Conclusions While HFS is becoming increasingly recognized amongst sexual medicine clinicians, there are currently no established efficacious treatment options. LiSWT shows potential as a treatment modality and may have increased efficacy if used in combination with PDE5 inhibitors, as demonstrated in this pilot study. Nevertheless, a larger case series is necessary to establish LiSWT as a standardized treatment option and may require a more comprehensive approach to properly manage this condition. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus.

Low-Intensity Shockwave for Treatment of Vestibulodynia: A Randomized Controlled Therapy Trial

BackgroundProvoked vestibulodynia (PVD) is an exhausting pain syndrome that immensely affects quality of sexual life and consequently negatively affects quality of life. Low-intensity shock wave therapy produces physical forces that lead to pain relief. AimThe aim of this study was to evaluate the feasibility, safety, and efficacy of low-intensity shockwave therapy in patients with provoked vestibulodynia. MethodsThis is a double-blinded, randomized, sham-controlled, prospective study of 32 women. The treatment protocol included a series of treatments, performed twice a week for 6 weeks. Each treatment consisted of 500 pulses of low intensity shockwaves (0.09 mJmm2) using the Medispec, ED-1000 shockwave generator or sham. Participants were assessed at the baseline, and at 1 and 3 months after completing all treatments. OutcomesPain was assessed by both subjective and objective measures. The primary outcome was a change in dyspareunia, as assessed by scores on the 10-point visual analog scale. Secondary outcome measures were changes in pain threshold and tolerance, assessed by a quantitative validated algometer test, the Wong-Baker pain FACES scale, the Female Sexual Function Index and the Patients’ Global Impression of Change scale. ResultsFrom the baseline to 1 month and 3 months after completion of treatment, visual analog scale scores for dyspareunia decreased (8.0 ± 1.4, 5.7 ± 2.3, and 4.4 ± 2.5, respectively, P < .005). For these respective time points, Wong-Baker scores decreased (4.0 ± 0.6, 2.9 ± 1.2, 2.5 ± 1.3, respectively, P < .05); and total Female Sexual Function Index increased (17.9 ± 6.3, 20.9 ± 6.2, 22.5 ± 8, respectively, P < .002). Pain threshold and tolerance measured by the algometer were increased 3 months after completion of the treatment compared with the baseline (69.8 mmHg ± 11.8 vs 22.9 mmHg ± 9.0, P < .01 and 87.7 mmHg ± 35.7 vs 43.3 mmHg ± 14.7, P < .0001, respectively). No changes were observed in any of the measures assessed in the sham group. Clinical ImplicationsWe found a new effective treatment for alleviating the most bothersome symptom in PVD, pain during penetration and intercourse. This resulted in improved sexual function. Strengths & LimitationsThe strengths of this study are the randomized controlled design, the correlated subjective questionnaires, and the use of semiquantitative algometer methodology. The limitations are the relative low number of participants in a single center. ConclusionFor women with PVD, low-intensity shockwave therapy applied at the introitus is a feasible, safe, and effective treatment option that may have a beneficial effect in pain relief and in sexual function.Gruenwald I, Gutzeit O, Petruseva A, et al. Low-Intensity Shockwave for Treatment of Vestibulodynia: A Randomized Controlled Therapy Trial. J Sex Med 2021;18:347–352.

SC100 - The efficacy of low-intensity shockwave therapy in patients with erectile dysfunction unresponsive to PDE5i treatment

SC100 - The efficacy of low-intensity shockwave therapy in patients with erectile dysfunction unresponsive to PDE5i treatment

Safety and Efficacy of Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction: A Systematic Review and Meta-Analysis

Background: Erectile dysfunction is a common disease that has a significant negative impact on the quality of life of individuals. Low-intensity shockwave therapy (LI-ESWT) has been considered a new method for treating patients with erectile dysfunction.Objectives: To evaluate the safety and efficacy of LI-ESWT in the treatment of patients with erectile dysfunction.Methods: A systematic review was conducted in the major databases, including PubMed, Cochrane Library, Embase, Scopus, and Web of Science up to February 2018. In order to find more articles, the reference list of the key review articles was searched as well. The quality of the studies was evaluated with the Cochrane Collaboration’s tools. The outcomes included The International Index of Erectile Function (IIEF), Erection Hardness Score (EHS), and adverse events. Meta-analysis was performed using RevMan software, version 5.3.ResultsSeven randomized clinical trials involving 519 patients met the inclusion criteria. A significant improvement was observed in IIEF (mean difference [MD] = 4.54, 95% CI 0.44 - 8.63) and EHS (risk ratio [RR] = 2.99, 95% CI 1.16 - 7.70) in the intervention groups compared to the control groups. Sub-analysis showed that shockwave therapy significantly improved IIEF at 6, 9, and 10 weeks after the treatment (P < 0.05), and the EHS was improved at 5, 6, and 9 weeks (P < 0.05). There was also a significant improvement in the intervention groups in IIEF and EHS for 1500 and 3000 pulses, respectively (P < 0.05). No significant side effects were reported.Conclusions: The findings of this study indicate LI-ESWT improves erectile dysfunction in patients, and it is safe and well-tolerated by patients.

Meta-analysis of randomized controlled trials that assess the efficacy of low-intensity shockwave therapy for the treatment of erectile dysfunction.

Background:The aim of this study was to perform a meta-analysis of randomized controlled trials (RCTs) that evaluate the efficacy of low-intensity extracorporeal shock wave therapy (LiESWT) for the treatment of erectile dysfunction (ED).Materials and methods:A comprehensive search of PubMed, Medline, and Cochrane databases was performed from November 2005 to July 2018. RCTs evaluating efficacy of LiESWT in the treatment of ED were selected. The primary outcomes were the mean difference between treatment and sham patients in the International Index of Erectile Function-Erectile Function (IIEF-EF) domain score 1 month after treatment, and the mean change in IIEF-EF from baseline to 1 month post-treatment. The secondary analysis considered the percentage of men whose erectile hardness score (EHS) changed from <2 at baseline to >3 after treatment. All analyses used a random effects method to pool study-specific results.Results:A total of seven RCTs provided data for 607 patients. The mean IIEF-EF 1 month post-treatment ranged from 12.8 to 22.0 in the treatment group versus 8.17–16.43 in the sham group. The mean difference between the treatment and sham groups at the 1 month follow up was a statistically significant increase in IIEF-EF of 4.23 (p = 0.012). Overall, five of the seven trials provided data on the proportion of patients with baseline EHS <2 who improved to EHS >3 at 1 month post-treatment. The proportions ranged from 3.5 to 90% in the treatment group versus 0–9% in the sham group and the pooled relative risk of EHS improvement for the treated versus sham group was 6.63 (p = 0.0095). No significant adverse events were reported.Conclusions:This is the first meta-analysis that evaluates RCTs exploring LiESWT as a treatment modality strictly for ED. This therapeutic strategy appears to be well tolerated with short-term benefits. However further studies exploring specific treatment regimens and long-term outcomes are needed.