DUOLITH SD1 T-TOP »ultra« URO

Stand-off device for different anatomies and penetration depths

Touch screen

Treatment parameters with images

Visible Body® digital anatomy atlas

The DUOLITH® SD1 T-TOP »ultra« is a shock wave system for treating urogynaecological and urological indications. In the field of urogynaecology, this includes vulvodynia and dyspareunia, diseases associated with chronic pelvic pain syndrome (CPPS). In urology, this includes vascular erectile dysfunction (ED), induratio penis plastica (IPP) and chronic pelvic pain syndrome. Scientific studies have proven the effectiveness of focused shock waves in treating these conditions.^1-7 

The effectiveness of the DUOLITH® SD1 T-TOP »ultra« is based on its individually adjustable, dynamic and optimally designed large energy range, as well as its selectable therapeutic focus depth. Deep areas can be treated with less effort, as they can be reached easily and with high accuracy through the optimal focus zone. Thanks to the ideal focus depth, it is sufficient to apply the shock waves from only one side of the penis in urological treatments. The anatomically shaped stand-off device ensures optimal adaptation to the anatomy of the penis during ED or IPP treatment.

Indications
Urogynaecology

• CPPS – chronic pelvic pain syndrome
  - Vulvodynia
  - Dyspareunia
   

Urology

• ED – erectile dysfunction
• IPP – induratio penis plastica (Peyronie’s disease)
• CPPS – chronic pelvic pain syndrome
    

Chronic pelvic pain syndrome in women is now recognised as a relatively common disease and includes various subgroups. Among these, vulvodynia is the most commonly occurring form, causing chronic pain or irritation in the vaginal area. Another subgroup is dyspareunia, whereby pain occurs in the genital area during or after sexual intercourse, which can partially or completely prevent vaginal penetration. CPPS and its associated symptoms significantly impact the quality of life of affected women and their partners.

CPPS can be triggered by pelvic infections, post-pelvic surgery, or by a variety of other factors. However, vulvodynia also often occurs in women as a functional disorder for which no clear cause can be identified. The standard treatment includes pain medication and physiotherapy.

Another non-invasive alternative is Extracorporeal Shock Wave Therapy (ESWT).^6,7 It allows ongoing treatments, such as physiotherapy, to continue while offering a combined therapy approach. 

ESWT induces both hyperstimulation of pain receptors, which blocks pain transmission, as well as modulation of pain memory. Both mechanisms can play a crucial role in treating CPPS. After ESWT, women report a significant reduction in pain in daily life and during sexual intercourse.

In shock wave therapy, CPPS patients receive a weekly perineal ESWT covering the entire vulva and perineal region. A session usually lasts about 15 minutes, and around four sessions are required on average, depending on the severity.

After ESWT, vulvodynia patients report considerable pain relief.⁶
Similarly, dyspareunia patients experience significant reduction in pain during sexual intercourse.⁷

In these two prospective, randomised, double-blind, placebo-controlled studies, 61 women with vulvodynia and dyspareunia were examined, respectively. The participants were divided into a treatment group and a placebo group. The treatment group received focused ESWT weekly over four weeks, targeting six regions in the vulva and perineum for vulvodynia and eight regions for dyspareunia. Stand-off device II was used for both indications.

The placebo group received a sham treatment without energy transmission. The results showed significant pain reductions in the treatment group, which continued in all follow-up examinations (1, 4 and 12 weeks after treatment).

Pain reduction in the treatment group consistently exceeded 30%, measured using the Visual Analogue Scale (VAS) and the Marinoff Dyspareunia Scale, with large effect sizes (Marinoff 0.825 and VAS 0.883). There were no significant differences between the groups before treatment, but statistically significant differences were observed after treatment. These results indicate that ESWT is an effective method for achieving long-term reduction of pain in vulvodynia and dyspareunia.

Vulvodynia treatment

Dyspareunia treatment

Erectile dysfunction (ED) is a common sexual dysfunction. Erectile dysfunction is defined as the inability to achieve or maintain an erection for satisfactory sexual intercourse. This can impair the quality of life of the affected men and their partners. Although ED is typically associated with older men, it affects a significant percentage of men in middle age onward.

Extracorporeal shock wave therapy is used to treat vascular erectile dysfunction (ED). In the treatment of ED with shock wave therapy, low-energy shock waves are applied to various treatment areas on the penis and perineum (crura penis).
The effectiveness of low-energy (low-intensity) Extracorporeal Shock Wave Therapy (LiESWT) in treating ED has been investigated in several studies. Several systematic reviews with the highest level of evidence, according to the Oxford Centre for Evidence-Based Medicine, concluded that LiESWT leads to an improvement in ED based on measurements of the International Index of Erectile Function (IIEF) and the Erection Hardness Score (EHS).^8-11

According to a systematic review analysing 14 studies with a total of 833 patients, LiESWT »may have the potential to become the first-line non-invasive treatment for ED patients«.⁸ A prospective, randomised, placebo-controlled, double-blind study from 2014¹ showed that 57% of men treated with LiESWT were able to achieve an erection and engage in sexual intercourse without medication after therapy. A study conducted in Australia in 2015² investigated the effectiveness, safety and patient satisfaction following LiESWT: Most patients reported an improvement of 5 points in the IIEF-5 score (60%) and over 50% in the EDITS score (Erectile Dysfunction Inventory of Treatment Satisfaction) (70%). The majority of patients were satisfied with the treatment (satisfaction level 4 on a five-point scale; 67%) and would recommend the treatment to their friends (80%). The effectiveness of LiESWT has also been confirmed in animal models, such as in a study published at the end of 2017¹², in which rats with ED caused by diabetes mellitus were treated with shock waves.

Induratio penis plastica (IPP), also known as Peyronie’s disease, is an acquired and usually progressive disease of the penis. The majority of affected men detect the condition by feeling thickened nodules (or plaques) under the skin of the penis. As the disease progresses, pain may occur in both the erect and non-erect state of the penis. Furthermore, an erection leads to curvature of the penis, making sexual intercourse difficult or even impossible.

In the treatment of IPP (Peyronie’s disease), extracorporeal shock waves are applied to the pain points in the penis. In a pilot study¹³, the penis was treated with shock waves once a week for a period of five weeks in a non-erect state. Eighteen months after the last shock wave session, the deviation angle was reduced from 59.3° ± 38.1° to 49.3° ± 32.5° (N = 24; p = 0.1496). The pain occurring during an erection disappeared in 15 out of 17 patients and was reduced in one other patient (p < 0.0001). 

After completing the shock wave treatment, 15 patients were able to engage in satisfactory sexual intercourse (compared to six patients before treatment). A clinical study³ conducted in 2009 with 100 patients concluded that ESWT eliminates pain and improves both erectile function and quality of life. At the 12-week follow-up, patients treated with shock waves showed a significant improvement in the mean VAS, IIEF-5 and QoL scores. At the 24-week follow-up, the mean IIEF-5 and QoL scores remained stable in ESWT patients, while the VAS score went down further. »Interestingly, after 24 weeks, the average plaque size and the average curvature angle in the placebo group were considerably higher than the baseline values and the results achieved with ESWT«.³ The authors of a systematic review published in 2017¹⁴ also concluded that ESWT can eliminate pain in patients with IPP / Peyronie’s disease.

Chronic pelvic pain syndrome (CPPS), also known as chronic abacterial prostatitis, is characterised by pain in the pelvic floor area. Other symptoms include urinary complaints without evidence of a urinary tract infection. Some of these patients also experience erectile dysfunction. CPPS occurs in men of all ages but is most common between the ages of 35 to 45.

In Extracorporeal Shock Wave Therapy (ESWT), the prostate and pelvic floor are treated with shock waves applied to the perineal area.

In a study conducted in 2009⁴, all patients in the treatment group showed a statistically (highly) significant improvement in pain, quality of life and urinary conditions after ESWT compared to the placebo group. The authors of the study concluded that ESWT is an interesting therapeutic option, as it is easy and cost-effective to apply, has no side effects and can be repeated at any time. The results of another study from 2013⁵ and a systematic review from 2016¹⁴ also confirmed that ESWT is a safe and effective short-term treatment for CPPS.