Low-intensity Shockwave Therapy Research Articles

The effect of combination treatment with low-intensity shockwave therapy and daily tadalafil on severe erectile dysfunction: a double-blind, randomized, sham-controlled clinical trial.

Patients with severe erectile dysfunction (ED) remain the most challenging group in terms of available noninvasive treatment modalities. The study sought to assess the role of combination therapy with low-intensity shockwave therapy (LiST) and daily tadalafil 5mg in a highly select group of patients with severe vasculogenic ED through a double-blind, randomized trial. Forty-eight sexually active men were randomly assigned to 12 sessions of LiST 3 times weekly and tadalafil 5mg once daily (n = 34) or sham therapy and tadalafil (n = 17) for 4 weeks. Patients were assessed at 1 and 3 months after completion of treatment. Improvement of erectile function was evaluated through the International Index of Erectile Function-Erectile Function domain (IIEF-EF) or 6-item IIEF and the Sexual Encounter Profile (SEP) diary. The primary outcome was the difference between the groups in the IIEF-EF at 3 months after completion of treatment. Secondary outcomes comprised (1) the difference between the groups in the IIEF-EF at 1 month after completion of treatment, (2) the difference between the groups in the "yes" responses to question 3 of the SEP diary at 1 and 3 months, and (3) the treatment-related adverse events. The number of patients attaining a minimal clinically important difference in the IIEF-EF (improvement of at least 7 points) was also assessed. After treatment, the absolute scores in the IIEF-EF were higher in patients receiving LiST and tadalafil vs sham therapy and tadalafil both at the 1-month (12.1 ± 2.4 vs 10.2 ± 1.7; P = .002) and at the 3-month (12.9 ± 2.1 vs 10.8 ± 1.8; P < .001) evaluation. Between the 2 groups, the proportion of "yes" responses to question 3 of the SEP diary was not statistically significant, whereas the number of patients attaining a minimal clinically important difference in the IIEF-EF was statistically significant only at the 3-month evaluation. No adverse events occurred. Application of LiST in patients with severe vasculogenic ED receiving daily dose tadalafil may further improve erectile function compared with tadalafil as a stand-alone treatment on the short term. Although we provided the first study in the field, severe vasculogenic ED was defined based on medical history and clinical examination and not based on penile ultrasound measures. The combination of 12 sessions LiST 3 times weekly and daily tadalafil for 4 weeks led to a 2-point difference in the IIEF-EF compared with sham therapy and daily tadalafil among patients with severe vasculogenic ED after 1 and 3 months from completion of treatment.

A randomized controlled trial evaluating low-intensity shockwave therapy for treatment of persistent storage symptoms following transurethral surgery for benign prostatic obstruction.

Low-intensity shockwave therapy (Li-SWT) can improve bladder function through enhancement of angiogenesis and nerve regeneration and suppression of inflammation and overactivity. In this trial, we aimed to evaluate the efficacy of Li-SWT on persistent storage symptoms after transurethral surgery (TUS) for benign prostatic obstruction (BPO). Between July 2020 and July 2022, 137 patients with persistent storage symptoms; urgency episodes/24 h ≥ 1 and daytime frequency ≥8, for at least three months after TUS for BPO were randomly allocated to Li-SWT versus sham versus solifenacin 10 mg/day in 3:1:1 ratio. The primary end point was the percent reduction from baseline in overactive bladder symptom score (OABSS) at 3-month follow-up. The changes in 3-day voiding diary parameters, quality of life (QoL) score, peak flow rate and residual urine at 3 and 6-month follow-up were compared. Treatment-related adverse effects were also evaluated. Baseline data were comparable between groups. The percent reduction from baseline in OABSS at 3-month follow-up was significantly higher in Li-SWT compared to sham (-55% versus -11%), and it was comparable between Li-SWT and solifenacin-10 (-55% versus -60%). Li-SWT achieved significant improvement like solifenacin-10 in 3-day voiding diary parameters and QoL score at 3-month follow-up. This improvement remained comparable between Li-SWT and solifenacin-10 at 6-month follow-up. No adverse effects related to Li-SWT were noted apart from tolerable pain during the procedure. Solifenacin-10 was associated with bothersome adverse effects in 73% of the patients with 11.5% discontinuation rate. Li-SWT ameliorates persistent storage symptoms and promotes QoL after TUS for BPO, with comparable efficacy and better tolerance compared to solifenacin.

LOW-INTENSITY SHOCKWAVE TREATMENT FOR NEUROGENIC BLADDER WITH CHRONIC URINE RETENTION - CASE REPORT

We present a case of neurogenic bladder accompanied by chronic urine retention in a patient diagnosed with multiple sclerosis (MS). This condition was effectively managed by low-intensity shockwave therapy (Li-ESWT). Low-intensity focused shockwave therapy (Li-ESWT) is becoming increasingly important in the treatment of urological problems. This case study investigates the feasibility and efficacy of using Li-ESWT to reduce post-void residual volume in persons with neurogenic bladder, representing the first examination of its sort. Bladder dysfunction (BD) frequently occurs in patients who have been diagnosed with multiple sclerosis (MS). Bladder dysfunction (BD) can occur due to the impairment of nerve impulses in the central nervous system regions involved for regulating bladder function and managing the contractions of the urinary sphincters, which is caused by the lesions associated with multiple sclerosis (MS). Urinary retention can cause various symptoms, including insufficient bladder emptying, urinary incontinence, frequent urinary tract infections, urosepsis resulting in the development of kidney abscesses due to localised kidney infection, and reduced kidney function. Optimal bladder function is essential for individuals with MS, as it plays a critical role in preserving kidney health, preventing urinary tract infections and incontinence, reducing the frequency of MS episodes, and improving their overall well-being. A 31-year-old woman was referred to our urology office with a chronic urinary tract infection caused by a neurogenic bladder with a significant volume of residual urine. A kidney abscess formation was identified as a complication. Li-ESWT, which stands for low-intensity extracorporeal shockwave therapy, was used as a part of a multimodal strategy to treat the urinary bladder. This treatment was delivered off-label. The therapy was given on a weekly basis for a period of 6 weeks. The procedure included administering 2500 shocks at a rate of four pulses per second, with an energy flux density (EFD) of 0.25 millijoules per square millimetre. The EFD (Energy Flux Density) used in our study exceeded 0.32 mJmm2,4, the fR (frequency rate) was set at 8 Hz (pulses per second), the treatment sessions consisted of 12 cycles of Li-ESWT (Low-Intensity Extracorporeal Shockwave Therapy), and a total of 3000 shocks were administered. At the intervals of one week, three months, six months, nine months, and twelve months following the administration of Li-ESWT and tadalafil 2.5 mg, the post-void residual (PVR) volume was consistently below 50 ml. The Li-ESWT treatment effectively reduced the post-void residual urine volume.Low-intensity extracorporeal shockwave therapy (Li-ESWT) can safely and efficiently decrease the amount of urine left in the bladder after voiding in individuals with neurogenic bladder caused by multiple sclerosis (MS). We have effectively demonstrated that Li-ESWT is a feasible and safe treatment for chronic urine retention, resulting in a decrease of post-void residual (PVR) volume from 200 ml to 50 ml. In the future, Li-ESWT has the potential to be advanced as a more efficacious alternative therapy for individuals experiencing chronic urinary retention. Further investigation is necessary to confirm the effectiveness of ESWT in addressing the neurogenic bladder.

(268) Intracavernous Prostaglandin Injection as a Predictor and Effectiveness Measure for LISWT Sessions in ED Patients: A Single Urologist's Experience

Abstract Introduction In recent years, therapeutic approaches for treating vasculogenic Erectile Dysfunction (ED) have evolved, with Low Intensity Shock Wave Therapy (LISWT) emerging as a promising modality. Objective To objectively evaluate the efficacy of LISWT for ED patients and to predict the required number of sessions, we examined the effects of administering up to 10 mcg of intracavernous alprostadil injections both before and after treatment Methods 85 vasculogenic ED patients (Average age: 57); 33 with mild to moderate ED and 52 with moderate or severe ED. Intracavernous injection (ICI) of ≤10 mcg of alprostadil was given before LISWT and one month post-treatment. Depending on ICI response, patients underwent either six (Erection Hardness Score (EHS) ≤3) or four (EHS=4) weekly LISWT sessions using PiezoWave2 from Richard WOLF. LISWT Parameters: 0.16mj/mm2 energy flux density, 8 Hz frequency, 10mm wave focus penetration depth, and 6000 shocks per session distributed among the two crura of the penis (2000 shocks), dorsum penis (2000 shocks), and lateral penis (2000 shocks). Results 33 patients showed a robust response to the 10mcg ICI and were treated with four LISWT sessions. 52 patients exhibited a partial response to the 10mcg ICI, necessitating six LISWT sessions. 78.6% (26 out of 33) of the patients who initially responded well to 10 mcg ICI had a consistent response to 8 mcg ICI; 63.6% (33 out of 52) of those with a partial initial response to 10 mcg ICI demonstrated an improved reaction to the same dosage post-treatment (table 1) (fig. 1). No complications were reported from the ICI. Conclusions Intracavernous prostaglandin injection can serve as a predictor for the required number of LISWT sessions and can objectively gauge the treatment's effectiveness in ED patients. Further randomized studies, incorporating parameters such as EHS, IIEF, and the ICI dosage, are recommended to validate this method's feasibility Disclosure No.

(193) Low Intensity Shockwave Therapy in Combination with Phosphodiesterase-5 Inhibitors is an Effective and Safe Treatment Option in Patients with Vasculogenic ED who are PDE5i Nonresponders: A Multicenter Single-Arm Clinical Trial

Abstract Introduction Low-intensity shockwave therapy (Li-ESWT) has been shown to be an effective and safe treatment for vasculogenic erectiledysfunction (ED) Objective We aim to evaluate the effectiveness and safety of LiESWT in treating patients affected from vasculogenic ED who did not respond to oral treatment with Phosphodiesterase 5 inhibitors (PDE5-i) Methods It is a multicentric open-label prospective study, in a cohort of patients non-responders to PDE-5i. Li-ESWT was performed in an outpatient setting by using the following schedule: 3000 shockwaves with an energy of 0.25 mJ/mm2 and a frequency of 4–6 Hz, twice a week for 3 weeks. International Index of Erectile Function, Erection Hardness Score and Sexual Quality of Life-Male questionnaires, and penile doppler ultrasound (PDU) are the outcome measurements. Results The Student t-test or Wilcoxon signed-rank test were applied to compare variables, with results considered statistically significant at p &amp;lt; 0.05. 106 (97.2%) completed treatment and performed follow-up visit after 4 weeks. At follow up visit, the mean IIEF-EF increased by 8.6 points (13.47 ± 4.61 vs 22.07 ± 5.27; p &amp;lt; 0.0001). A clinically significant improvement of IIEF-EF was achieved in 75 patients (70.7%). An EHS score ≥ 3, sufficient for a full intercourse, was reported by 72 patients (67.9%) at follow-up visit. 37 (34.9%) patients reported a full rigid penis (EHS = 4) after treatment. Li-ESWT treatment was also able to improve quality of life (SQOL-M: 45.56 ± 8.00 vs 55.31 ± 9.56; p &amp;lt; 0.0001). Li-ESWT significantly increased mean PSV (27.79 ± 5.50 vs 41.66 ± 8.59; p &amp;lt; 0.0001) and decreased mean EDV (5.66 ± 2.03 vs 1.93 ± 2.11; p &amp;lt; 0.0001) in PDU. Conclusions Combination of Li-ESWT and PDE5-i represents an effective and safe treatment for patients affected from ED who do not respond to first line oral therapy Disclosure No.

(289) Combined Therapy with Low-intensity Shockwave Therapy and Daily PDE5i Showed Better Pain Relieve and Sexual Function Improvement in Acute Phase of Peyronie Disease

Abstract Introduction To compare the efficacy and safety of daily use PDE5i and PDE5i combined with linear low-intensity shockwave therapy (Li-SWT) in the treatment of acute phase of Peyronie disease (PD). Objective 68 patients with acute PD within 6 month onset were collected. The patients were 26–56 years old with an average of 42.3 years. The patients were randomly divided into two groups, 35 of which were orally administered with 5 mg of tadalafil every night for 3 months; the other 33 received 4 times of Li-SWT with daily PDE5i. Li-SWT uses the Renova shock wave therapy device with an energy density of 0.09mJ/mm2, each time 3200 times in the penile plaque, 900 times in the left and right penile shaft, and once a week for 4 consecutive treatments as a cycle. All patients underwent ultrasound or MRI, penile bending angle measurement, improvement of subjective symptoms, and IIEF-5 scale before and after treatment. Methods 68 patients with acute PD within 6 month onset were collected. The patients were 26–56 years old with an average of 42.3 years. The patients were randomly divided into two groups, 35 of which were orally administered with 5 mg of tadalafil every night for 3 months; the other 33 received 4 times of Li-SWT with daily PDE5i. Li-SWT uses the Renova shock wave therapy device with an energy density of 0.09mJ/mm2, each time 3200 times in the penile plaque, 900 times in the left and right penile shaft, and once a week for 4 consecutive treatments as a cycle. All patients underwent ultrasound or MRI, penile bending angle measurement, improvement of subjective symptoms, and IIEF-5 scale before and after treatment. Results In the PDE5i group, the pain symptom relieve were improved in 80% patients (28 of 35 cases), while the combined group (PDE5i+Li-SWT) were improved in 90.9% patients (30 of 33 cases). The IIEF5 score in the PDE5i group improved from 13.8±7.9 to 19.5±8.1 and from 13.4±7.6 to 21.3±9.2 in the combined group, with both improvement between two groups. The plaque size were shrinkage 5 cases in PDE5i group and 12 cases in combined group, but penile curvature did not change significantly in both groups. In the PDE5i group, 5 patients had mild dizziness and back pain, while 3 patients had mild dizziness and back pain in combined group. There was no obvious adverse reaction observed for Li-SWT treatment. Conclusions Both the daily use PDE5i and the PDE5i combined with Li-SWT can improve the symptoms of acute PD patients, mainly to relieve pain and improve erectile function in some patients. The combined group had a better pain symptom relieve rate and more improvement for sexual function. The two methods can reduce PD plaque size in some cases, while both groups did not significantly change penile curvature. Both methods have good safety in the treatment of acute phase PD. Disclosure No.

(281) Low-Intensity Shockwave Therapy Combined with Tadalafil 5mg Daily has Better Efficacy for Mild and Moderate Erectile Dysfunction: The Preliminary Results of a Multicenter Clinical Study in China

Abstract Introduction Most clinical studies have demonstrated that low-intensity extracorporeal shockwave therapy (Li-ESWT) can improved erectile function in patients with erectile dysfunction (ED). The EAU guideline recommended to use Li-ESWT for mild vasculogenic ED patients. However, the therapeutic advantages of Li-ESWT combined with phosphodiesterase type 5 inhibitors (PDE5i) have not been explored clearly in clinical practice for mild and moderate ED patients. Objective To compare the therapeutic effects of Li-ESWT and Li-ESWT combined with PDE5i in mild and moderate ED patients with 8≤IIEF-5≤16 from a multicenter clinical study in China. Methods Patients with ED which IIEF-5 score is less than 22 and aged 18–60 years old were enrolled from three clinical centers from Jun. 2019 to Mar. 2023. The demographic data, International Index of Erectile Function-5 (IIEF-5), erectile hardness score (EHS) and self-reported symptom questions were collected. Patients were treated by a linear low-energy shock waves generator (Renova). Low-intensity shock wave (energy density of 0.09mJ/mm2) treatments were applied (once a week, 4 weeks in total, 5000 shocks each time). Patients in Li-ESWT combined with PDE5i group took 5mg of tadalafil once a day for one continuous month during ESWT. Comparative analyses of pre- and post-treatment and intergroup were used for statistics. Results In total, 42 ED cases (37.43±11.86 years) in Li-ESWT group and 116 cases (37.41±10.14 years) in combined group were enrolled for analysis. The IIEF-5 score and EHS in both groups were significantly improved after 1 month treatment (p&amp;lt;0.01). Compared with Li-ESWT group, patients in combined group significantly had higher self-reported efficiency (61.2% vs. 47.6%, p=0.013), IIEF-5 scores (15.34±7.15 vs. 13.96±7.71, p=0.039) and EHS (2.85±0.82 vs. 2.69±0.89, p=0.050). In the mild and moderate ED (with 8≤IIEF-5≤16) sub-group, 30 ED cases (36.81±10.99 years) in Li-ESWT group and 96 cases (36.80±10.69 years) in combined group were enrolled for analysis. The combined regimen showed better therapeutic advantages, including effective parameters IIEF-5(14.50±6.74 vs. 12.87±8.54, p=0.040), EHS (2.85±0.75 vs. 2.81±0.67, p=0.046) and self-reported efficiency (64.2% vs. 54.1%, p=0.001). Conclusions Li-ESWT can effectively improve erectile function in this multicenter clinical study in China, and the combination of Li-ESWT with daily use PDE5i had a better therapeutic effect on Chinese ED patients, especially on mild and moderate ED. Long-term follow-up with large sample study need to be developed for exploring the optimal therapeutic regimen. Disclosure No.

(230) Investigating the Efficacy, Satisfaction, and Predictors of Response to Low-Intensity Shockwave Therapy for Erectile Dysfunction

Abstract Introduction Erectile dysfunction (ED) affects 52% of men in the US, with treatment modalities varying significantly in their degree of invasiveness. Low-intensity shockwave therapy (LI-SWT) is an emerging non-invasive therapy that uses acoustic waves to improve cavernosal arterial flow by inducing microtrauma and subsequent angiogenesis, in addition to enhancing tissue regeneration and reducing local inflammation. Objective Our objective is to investigate the efficacy of LI-SWT, identify factors predictive of response, and explore patient satisfaction and attitudes towards the therapy. Methods An IRB-approved retrospective chart review and survey study was conducted, examining 102 men who underwent LI-SWT for ED between 2009-2022 at a single tertiary referral center. Univariate and multivariate analyses were performed in JMP. Results Out of 102 men, 50 (49.0%) subjects responded to the survey. 22 (44.0%) men reported clinical responses to LI-SWT, with an average improvement of 1.46 on the validated Erection Hardness Score (EHS; scale 0-5). Clinical responders noticed their first response after a mean of 3.53 treatments. 48 of the respondents (96.0%) had previously trialed PDE5 inhibitors, while 18 (36.0%) men previously trialed intracavernosal injections (ICI). On univariate analysis, alcohol use (OR 0.23, 95% CI 0.07-0.77, p =0.015) and prior ICI (OR 0.23, 95% CI 0.05-0.95, p=0.036) use were both associated with lower odds of response to LI-SWT. Interestingly, history of radical prostatectomy (RP) did not correlate with LI-SWT response (p=0.117). These results were redemonstrated on multivariate logistic regression, with alcohol use (OR 0.23, p=0.039) and prior ICI use (OR 0.17, p=0.047) again predicting lower odds of LI-SWT response. Of 28 men who did not benefit from LI-SWT, 5 (18%) progressed to ICI, and 3 (11%) progressed to inflatable penile prosthesis (IPP). Out of all respondents, only 2 men (4%) experienced side effects, which consisted of mild transient pain/paresthesia. No hematomas or bruising were reported, including 8 men on anticoagulants. Clinical responders demonstrated a higher mean satisfaction score of 7.1 on the 10-point Likert scale (somewhat satisfied) compared to non-responders who scored an average satisfaction score of 2.3 (somewhat dissatisfied). Surprisingly, the majority (66%) of the survey respondents were willing to try LI-SWT again, including 54% of first time non-responders. Conclusions Patients with a history of alcohol use and/or prior ICI use were associated with a lower likelihood of response to LI-SWT. LI-SWT demonstrated promising results as a non-invasive option for ED treatment, including treatment refractory ED as well as post-prostatectomy ED, with minimal adverse events. Responders viewed LI-SWT favorably as a modality for treating ED, and the majority of patients who had undergone LI-SWT were willing to try it again. These findings support the use of LI-SWT before resorting to more invasive ED therapies, including surgery. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Mohit Khera - consultant for Endo, Petros, AbbVie, Tolmar, Marius, Halozyme, Boston Scientific.

(152) Energy Absorption Simulation During Low Intensity Shockwave Therapy

Abstract Introduction Low intensity shockwave therapy (LiSWT) has been used to treat erectile dysfunction since 2010 by inducing mechanotransduction. The greater the shockwave energy absorbed in cavernosal erectile tissue, the greater the opportunity for mechanotransduction regenerative mechanisms to occur and improve erectile function. Effectiveness of LiSWT depends, in part, on applied energy (mJ/mm2) and number of applications (total shocks). Although intensity of LiSWT energy cannot be arbitrarily increased due to side effects, energy absorption may be improved by performing treatment to an erect vs flaccid penis. Intracavernosal pressure and penile volume are both determinants of velocity of the energy wave in tissue and therefore absorption of shockwave energy in tissue. Intracavernosal penile pressure when erect (100 mmHg) is 16-fold higher than flaccid (6 mmHg), and blood volume when erect (142.6 cm3) is &amp;gt;2 times more than flaccid (62.18 cm3), therefore LiSWT in the erect state with larger blood-filled lacunar spaces should be associated with greater shockwave energy absorption. Use of a symmetry-matched secondary reflector can further increase the energy absorption of each applied shockwave by reflecting the wave back. Objective The aim of this study was to perform a simulation of energy absorption during LiSWT with a reflector in both the flaccid and erect penis. Methods This energy model used the MTS UroGold electrohydraulic shockwave device [Softwave TRT]. When sound waves pass through an interface between 2 media with different impedances, sound propagation can be significantly altered. If impedances of the media are different, part of the sound energy is reflected into the incident medium; the rest of the sound energy is transferred to the second medium. Sound propagation in tissue can be illustrated via computer simulation by mathematically calculating the damping and deflection of the sound wave by different tissue structures. Finite Element Method (FEM) simulation models are particularly suitable for the mathematical description of complex processes of shockwave propagation, such as in the flaccid and erect penis. Based on results, a “prediction” of propagation of LiSWT in tissue is possible. This patient-specific procedure is based on consideration of individual anatomical structures: corporal lacunar spaces and physical-acoustic laws. For FEM modeling of LiSWT propagation, program systems ANSYS, MATLAB and PZFLEX/ONSCALE were used. Results Using the FEM calculation model of the simulation analyses, the shockwave pulse is applied at the bottom edge of the model (Fig 1). It propagates through the erect (Fig 2a) and flaccid (Fig 2b) states, with the most energy absorption in the erect penis, shown in red. The effect of increased penile pressure on energy absorption with a constant volume is shown in Fig 3. Conclusions More energy is absorbed in cavernosal tissue during erection than in the flaccid state, with a further increase in absorption with use of a symmetric reflector. This provides greater opportunity for beneficial mechanotransduction regenerative mechanism due, in part, to increased intracavernosal pressure and tissue volume with larger blood-filled lacunar spaces during erection. LiSWT to treat erectile dysfunction should be more effective when performed in the erect state utilizing a reflector. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: MTS Medical, Softwave TRT.

(151) Safety and Feasibility of the COCKTAIL (Combining Shockwave Therapy and Platelet-Rich Plasma for Erectile Dysfunction) Trial: A Single Center, Randomized, Double-Blind, Sham-Controlled Study Update

Abstract Introduction Therapeutic approaches focusing on tissue neovascularization play a crucial role in the development of treatments for erectile dysfunction (ED). Autologous Platelet-Rich Plasma (PRP) and Low-Intensity Shockwave Therapy (SWT) are two restorative therapies that potentially target underlying causes of ED. Pre-clinical evidence suggests their angiogenic and regenerative properties, indicating a potential synergistic pathway to improve vasculogenic ED. Objective The primary objective aims to investigate and compare the treatment efficacy of PRP injection and SWT vs placebo injection/SHAM treatment in men with mild-moderate ED, as measured by IIEF. The secondary objective aims to study incidence of adverse events and safety of PRP injection and SWT treatment in men with mild-moderate ED, as measured by IIEF. Methods The COCKTAIL (Combining Shockwave Therapy and Platelet Rich Plasma) trial is a Phase II, single-center study assessing the safety and efficacy of PRP and SWT in combination for ED (NCT05048667). Thirty-five men with mild to moderate ED were enrolled based on International Index of Erectile Function-EF subdomain (IIEF-EF) questionnaire (12-25). Data from a cohort of men treated with PRP and SWT were analyzed, comparing it to men who received placebo saline injections and sham SWT. Patients received two PRP or placebo injections directly into the corpus cavernosum and penile SWT every week for 5 weeks. Assessment included pain scale evaluations, immediate post-procedure examination, and follow-up for complications. IIEF scores were recorded at baseline, 3-month, and 6-month follow-up visits. All statistics and analyses were conducted with IBM SPSS Statistics 27.0.1. Non-parametric tests were used for analysis. Mann-Whitney U test was used to compare independent groups (Group A vs. Group B) at different time points. Related Samples Wilcoxon -Signed Rank test was used for dependent repeated groups, the serial measurements of IIEF-EF scores at different time points for each patient within a specific group. Findings at p&amp;lt; 0.05 were considered statistically significant. Results The primary endpoint of this study was to investigate the incidence of Serious Adverse Events (SAEs). Encouragingly, no adverse events were reported, suggesting that the procedure appears to be safe for the participants. The median baseline IIEF scores for patients in Group A were 17 (±4), and at the three-month follow-up, the scores increased to 19 (±4), slightly dropping to 18 (±8) at six months. In Group B, the median baseline IIEF scores were 19.50 (±4), which improved to 20 (±7) at the three-month follow-up and further increased to 21 (±10) at six months. No statistical differences were found likely because this is an ongoing study, and we only have complete data for 12 men. We aim to accrue a total of 30 men in each arm and plan to complete the recruitment by January 2024 and complete the study by July 2024. Currently, both the investigators and the patients remain blinded. Conclusions The combination of PRP and SWT appears to be safe, as no adverse events were reported. Although preliminary data do not show differences between the treatment and sham groups currently, we intend to complete the trial to perform a comprehensive statistical calculation for efficacy. Disclosure No.

(232) The Use of Restorative Therapies for Erectile Dysfunction: A Review of the Current Canadian Landscape

Abstract Introduction Erectile dysfunction (ED) is the inability to achieve or maintain an erection that is sufficient for sexual performance. Restorative therapies are heralded as options to restore one’s natural, spontaneous erection without the need for pharmacologic therapy. There is a growing interest in these therapies including low-intensity shockwave therapy (Li-EST), platelet-rich plasma (PRP) and stem cells for the treatment of ED. However, limited data exists to support their routine clinical use. With direct-to-consumer marketing, numerous clinics across Canada now offer this therapy. We sought to investigate the landscape of restorative therapies for ED across Canada. Objective The objective is to evaluate how restorative therapies for ED are being marketed and administered to patients. Our study hopes to analyze cost, indications for treatment, equipment utilized, treatment protocol, clinic ownership, level of training for staff, and whether a urologic consult is required prior to treatment. Methods Searches were made on a private Google browser with queries that include phrases “Shockwave therapy for erectile dysfunction in Province/Territory”, “PRP therapy for erectile dysfunction in Province/Territory”, among others. Searches were also made to include any stem cell regenerative therapies for ED. Clinics advertising their services online had their public website analysed for preliminary data collection. Our team captured data on costs, treatment duration, success rates, adjuvant therapies administered and more. Data obtained was then compared against existing literature to assess the accuracy of marketing towards patients. Results To date, we have obtained preliminary results from 107 clinics across Canada offering a form of restorative therapy for ED. We hope to contact every clinic offering these services in Canada by the end of the study period in August of 2023. Out of the identified clinics thus far, 72.9% are offering SWT and 49.5% are offering PRP treatment for ED, with 27.1% of clinics offering both. Our team was unable to identify any clinics providing stem cell therapy for ED. The average cost of SWT from the data we have collected thus far is $1701.92, ranging from $500 to $3500 for a six-treatment protocol that a majority of clinics opt for. Similarly, the average cost of PRP is $1458.22, ranging from $875 to $2000 per treatment. 15% of clinics reported a success rate for SWT, with a mean of 76.81% (ranges 50-100%). A singular clinic has quoted the success rate of PRP at 75% currently. Out of the 107 clinics contacted, 74 of them listed their ownership and staff. 12.2% of the clinics that listed their staff had a urologist present, 56.8% of them had a non-urologist MD employed on staff, and 31.1% did not have an MD present at the clinic. Conclusions Our study has so far found that Li-SWT and PRP for restorative therapies are being largely marketed directly-to-consumer with very little urologic intervention prior to treatment throughout Canada. The study highlights similar trends found in the US, taking advantage of the psychosocial burden faced by patients that suffer from ED, tacking on substantial financial costs for restorative therapies. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific.

(239) Stem Cell Therapy for Erectile Dysfunction Across States – Fact or Fiction?

Abstract Introduction While conventional treatments exist for erectile dysfunction (ED), the growing interest in alternative therapies has brought stem cell therapy to the forefront. Stem cells, with their regenerative potential, hold promise for addressing a wide range of diseases, including ED. However, the overall efficacy and potential risks of stem cell therapy for ED remain uncertain. Despite the limited evidence, an increasing number of clinics in the US offer these treatments. This study aims to analyze businesses marketing stem cell therapies and public interest in them. Objective To quantify data in the treatment of erectile dysfunction (ED) with stem cell therapy as marketed by U.S. companies. By querying Google trends, this study provides a novel epidemiological tool for geographically mapping search intent in relation to stem cell use and ED. Methods Google trends were extracted to trace stem cell related search intents combined with ED related searches within past 5 years in U.S. Weather related searches are predicted to remain consistent across time, thus were implemented as a control of Google searches. In addition, data collected regarding stem cell search trends were regressed on state GDP to correlate the degree to which price influences those interested in the novel treatment. The derived data was then implemented into a nationwide heat map to determine which states harbor the most interest (Figure 1). Individual Income Tax Statistics- Zip Code Data (SOI) were used to further explore correlation of public interest with individual’s annual income in the top 4 searched states. Results From the available patient websites, there were 6 practicing clinics within the U.S. that offer stem cells for ED, with out-of-pocket expenses averaging $5000 to $10000 per treatment. The types of stem cells advertised on these websites included umbilical derived, adipose derived, bone marrow derived and blood derived stem cells. Using the heat map, states with the highest search intents were in Florida, California, Massachusetts, New York, and Arizona. While stem cell average search intent exponential increase was observed over the past 5 years relative to platelet rich plasma (PRP), it was not as high as that of low-intensity shockwave therapy increase: stem cell= 11.3 Arbitrary Units (A.U), shockwave= 35.4 A.U, and PRP= 10.8 A.U. Using linear regression, a correlation of r = 0.132 was observed between a higher State GDP per capita and a higher search intent (Figure 2). Furthermore, SOI was analyzed for the highly searched states to explore the specific search interest for the public with corresponding zip codes of an annual income &amp;gt; $200,000. In Arizona, for example, a conspicuously great number of individuals who make &amp;gt;$200,000 annually demonstrated an even increasing higher correlation regarding interest in stem cell treatment for ED. Conclusions With different sites offering such therapy across the US, there is a growing interest in stem cells and other regenerative therapies for ED with the affluent areas having more interest in these therapies, likely due to the high cost of treatment Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Advisory board and speaker for Coloplast; consultant for Cynosure; advisory board and speaker for Halozyme; intellectual property with Masimo; advisory board for Promescent; consultant for Sprout; advisory board for Xialla.

Variations in Low Intensity Shockwave Treatment Protocols for Erectile Dysfunction: A Review of the Literature and Guide to Offering Treatment.

Low-intensity shockwave therapy (LiSWT) for erectile dysfunction (ED) continues to gain popularity in both clinical practice and the academic literature. The majority of trials and meta-analysis studies have shown LiSWT to be low risk with a trend toward positive improvements in International Index of Erectile Function (IIEF) scores. However, there is still debate over the clinical utility of LiSWT and there is no agreed upon optimal treatment protocol. In this review article we summarize published meta-analysis studies of LiSWT for ED, and review the treatment protocols from randomized sham-control trials published in the last 10 years. We found the most common device settings were an energy of 0.09 mJ/mm² and a frequency of 5 Hz. Shock number and location varied, but the most common protocol was 1,500 shocks per session, with 900 shocks to the penis (shaft, base, or hilum) and 600 shocks to the proximal corpora/crura. Protocols ranged from 4 to 12 treatment sessions. We also describe our institutional experience with LiSWT, including patient counseling and treatment protocol.

Physical Modalities for the Treatment of Localized Provoked Vulvodynia: A Scoping Review of the Literature from 2010 to 2023.

Localized provoked vulvodynia (LPV) is a prevalent sexual health condition with significant negative impacts on quality of life. There is a lack of consensus regarding effective management. We used Arksey and O'Malley's five-step method to identify, collate, and evaluate literature published between 2010 and 2023. The scoping review investigated the efficacy or effectiveness of interventions in the management of LPV. The aim of this paper is to map the literature on the efficacy or effectiveness of physical interventions. The review produced 19 primary studies of physical interventions for LPV. These include acupuncture, laser therapy, physiotherapy, transcutaneous electrical nerve stimulation, low-intensity shockwave therapy, transcranial direct current stimulation, and vestibulectomy. Published studies that investigated a range of physical treatments for LPV showed some positive effects, except for transcranial direct-current stimulation. The remaining modalities demonstrated improved sexual pain and treatment satisfaction, when measured. Findings were mixed for non-sexual pain. There was insufficient evidence to draw conclusions regarding other outcomes. Researchers are encouraged to conduct larger, high-quality studies that sample more diverse patient populations and use patient-oriented outcomes to assess effectiveness of physical modalities.

Platelet-rich plasma intracavernosal injections for the treatment of primary organic erectile dysfunction: a systematic review and meta-analysis of contemporary controlled studies.

We aim to summarize the latest evidence on platelet-rich plasma (PRP) intracavernosal injections efficacy in men affected by primary organic erectile dysfunction (ED). We reviewed the literature for randomized controlled trials (RCTs) or prospective and retrospective comparative studies evaluating PRP alone or in combination for ED treatment. A comprehensive search in PubMed, Scopus, Web of Science, and ClinicalTrials.gov was performed for English language full-text articles or conference abstracts. A qualitative and quantitative data synthesis was provided. Overall, seven records were included: three RCTs evaluated PRP vs. placebo, one study separately tested PRP and low-intensity shock wave therapy (Li-SWT), three studies compared Li-SWT or low-intensity pulsed ultrasound alone with their combination with PRP. Of 641 included patients, 320 received PRP. Despite the heterogeneity among inclusion criteria, dose and protocol of PRP administration, and outcomes measured, most studies independently reported better sexual outcomes in patients who received PRP, without significant severe side effects. In meta-analysis, where only placebo-controlled studies were included, patients treated with PRP showed higher International Index of Erectile Function (erectile function domain) score compared to patients who received placebo: pooled mean difference (95% Confidence Interval) of 2.99 (1.86, 4.13) after 1 month (209 patients) vs. 2.85 (1.61, 4.09) after 3 months (204 patients) vs. 3.21 (1.82, 4.60) after 6 months (199 patients) of follow-up. In men affected by primary organic ED, PRP intracavernosal injections demonstrated an objective improvement or at least a tendency in erectile function recovery. Patient numbers, and the short-term follow-up may limit the generalizability of these observations. High quality, large-scale, and standardized controlled trials are needed before recommending its definitive use in clinical practice.

Patients' attitude with surgery for Peyronie's disease: results from a multicentric European study.

Despite the existence of conservative therapies for Peyronie's disease (PD), surgery is commonly utilized for the treatment of bothersome curvatures due to its potential effectiveness, although it carries intrinsic risks and may not universally lead to satisfactory outcomes. To explore the rate and factors influencing patients' willingness to undergo surgery for PD. Data were prospectively collected in 5 European academic centers between 2016 and 2020. Data included age, time from PD onset, penile pain, curvature degree, difficulty at penetration, hourglass deformity, erectile dysfunction (ED), and previous treatments. All patients were offered conservative treatments, either medications or injections. Tunical shortening or lengthening procedures were offered as an alternative to conservative treatments, when indicated. Penile prosthesis was offered to those with concomitant ED. Patients' attitudes with surgery were recorded. Logistic regression analyses tested the profile of patients who were more likely to be willing to undergo surgery. Patients' willingness to undergo surgery for PD. This study included 343 patients with a median age of 57.3years (IQR, 49.8-63.6) and a median penile curvature of 40.0° (IQR, 30.0°-65.0°). Overall, 161 (47%) experienced penetration difficulties and 134 (39%) reported ED. Additionally, hourglass deformity and penile shortening were reported by 48 (14%) and 157 (46%), respectively. As for previous treatments, 128 (37%) received tadalafil once daily; 54 (16%) and 44 (13%), intraplaque verapamil and collagenase injections; and 30 (9%), low-intensity shock wave therapy. Significant curvature reduction (≥20°) was observed in 69 (20%) cases. Only 126 (37%) patients were open to surgery for PD when suggested. At logistic regression analysis after adjusting for confounders, younger age (odds ratio [OR], 0.97; 95% CI, 0.95-1.00; P = .02), more severe curvatures (OR, 1.04; 95% CI, 1.03-1.06; P < .0001), and difficulty in penetration (OR, 1.88; 95% CI, 1.04-3.41; P = .03) were associated with a greater attitude to consider surgical treatment. The need for effective nonsurgical treatments for PD is crucial, as is comprehensive patient counseling regarding surgical risks and benefits, particularly to younger males with severe curvatures. Main limitations are the cross-sectional design and the potential neglect of confounding factors. Patients with PD, having a lower inclination toward surgery, emphasize the need for effective nonsurgical alternatives and accurate counseling on the risks and benefits of PD surgery, particularly for younger men with severe curvatures.

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 &amp;lt; .001), with 20 (54.6%) having an increase ≥5. Of the 25 men with an initial Erection Hardness Score &amp;lt;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.

Do Antiplatelet Drugs Use Contribute to Clinical Outcomes in Patients Receiving Penile Low- Intensity Shock Wave Therapy (Li-SWT) for Erectile Dysfunction?

Aim: Low-intensity extracorporeal shock wave therapy (Li-SWT) is one of the recommended treatment options in patients with erectile dysfunction (ED). Li-SWT is safe in patients using antiplatelet drugs (APs), however, there are no specific studies on the contribution of APs use to clinical improvement in erectile function. We aimed to evaluate the early clinical results of Li-SWT administration and whether the use of APs had an additional positive contribution to clinical improvement and safe in ED patients.&#x0D; Methods: Patients with ED for more than 6 months despite using (5 mg/day) PDE5i were included in our study. Patients treated with Li-SWT and using PDE5i were classified as Group 1, patients treated with Li-SWT and using APs and using PDE5i were considered Group 2. The evaluation results of the International Index of Erectile Function-Erectile Function Area(IIEF-EF) in all patients baseline and after treatment were examined.&#x0D; Results: There are 25 patients in each group. Analysis of IIEF-EF scores showed significant increases in both groups after treatment [group 1 (p=0.001); group 2 (p=0.001)]. When the IIEF-EF scores of the groups before and after the treatment were compared with each other; it was shown that baseline scores were similar(p=0.746) and that APs use had no statistically significant effect on post-treatment scores (p=0.613) No side effects were seen in APs.&#x0D; Conclusions: This study showed that penile Li-SWT significantly increases the IIEF-EF scores and response of (5 mg/day) PDE5i in ED patients and safe, also in AP users. However, Using AP in Li- SWT does not contribute positively to clinical results.

Survey of the quality and origins of websites on penile low-intensity shockwave therapy in Canada.

The aim of this study was to establish the quality of patient-facing websites advertising low-intensity shockwave therapy (LISWT) for erectile dysfunction (ED) and Peyronie's disease (PD) patients in Canada. Canadian websites offering LIWST for ED or PD were identified using online web searches. The characteristics of these websites were reviewed, along with examining the presence of HONCode certification, assigning a brief DISCERN score (a tool designed to evaluate health information online) and readability scores. We also examined the LIWST technology advertised, as well as benefits of LIWST cited by the websites. Twenty-five unique websites linked to 46 clinics were identified and reviewed. Twenty-four percent of websites were run by a urologist. Other specialties offering LISWT included general practitioners, anesthesiologists, naturopaths, nurse practitioners, physiotherapists, and registered massage therapists. Twenty-four percent of the websites advertised the use of a focused shockwave generator. Forty percent of the websites had peer-reviewed references. The average brief DISCERN score was 14 (standard deviation 3.4). There was no association between the physician-or non-physician-led websites and the use of peer-reviewed references, readability scores, the number of clinic locations, or higher brief discern scores. LISWT is readily advertised online for ED and PD patients in Canada; however, only a minority use a focused shockwave generator. There is a wide diversity of practitioners offering LISWT. Websites offering LISWT are generally of poor quality and do not provide adequate information for patients to make educated treatment decisions.