STORZ Medical · Focused Shockwave Therapy · Part 2 of 2

DUOLITH® SD1 T-TOP »ultra«

Sexual Rejuvenation & Regenerative Sexual Medicine — Male & Female Protocols

The DUOLITH® SD1 T-TOP »ultra« is Storz Medical's flagship focused electromagnetic shockwave platform — the device on which the majority of the published clinical evidence for low-intensity focused shockwave therapy (Li-ESWT) in sexual medicine has been generated. Non-invasive, evidence-based, and clinically validated for male and female sexual rejuvenation. Available exclusively through Evoskin.

Available exclusively through Evoskin
DUOLITH SD1 T-TOP ultra focused shockwave system
Li-ESWTLow-intensity focused shockwave
0–65 mmAdjustable focal depth
SEPIA®Anatomically shaped stand-off
Non-InvasiveNo sedation · No downtime
The Technology, in Brief

Precision Energy Directed at the Anatomical Source of Dysfunction

Focused shockwave therapy (ESWT) delivers high-energy acoustic pulses that converge at a defined focal point within tissue, generating targeted mechanical stimulation at precise anatomical depths while leaving surrounding structures undisturbed. The DUOLITH® SD1 T-TOP »ultra« generates these focused electromagnetic shockwaves through the SEPIA® handpiece, with focal zone depth adjustable from 0 to 65 mm and therapeutic penetration reaching up to 125 mm — sufficient to reach cavernous tissue, prostatic and pelvic floor anatomy, and other structures inaccessible to radial devices.

The biological effects are well-characterized: focused shockwaves trigger mechanotransduction cascades that upregulate VEGF and eNOS, induce neoangiogenesis, activate Schwann cell proliferation and axonal remyelination, and modulate nociceptor hyperstimulation. In sexual medicine, these are the precise mechanisms that address the vascular, neurogenic, and fibrotic substrates of sexual dysfunction — at their anatomical source, not just their symptoms.

Focused DUOLITH shockwave handpiece with precision energy visualization
DUOLITH stand-off accessories showing focal zone and penetration depth
0–65 mmMechanically adjustable focal depth through the stand-off system.
Up to 125 mmTherapeutic penetration for cavernous tissue, prostatic and pelvic floor anatomy.
Focused EnergyEnergy converges at a defined point instead of dispersing from the tissue surface.
Private regenerative sexual medicine consultation for an adult couple
Sexual Medicine

Low-Intensity Focused ESWT · Male & Female Sexual Health

Regenerative Sexual Medicine. Evidence-Based. Non-Invasive.

The application of low-intensity focused extracorporeal shockwave therapy (Li-ESWT) in sexual medicine represents one of the most compelling intersections of precision biophysics and regenerative biology in contemporary medicine. The DUOLITH® SD1 T-TOP »ultra« is the platform on which the majority of the published clinical evidence in this field has been generated — making it the device of record for practices committed to evidence-based sexual medicine.

Li-ESWT for sexual medicine operates at lower energy levels than aesthetic protocols, targeting the vascular, neurogenic, and fibrotic components of sexual dysfunction at their anatomical source. The SEPIA® handpiece's anatomically designed stand-off system allows precise, comfortable adaptation to the relevant pelvic and genital anatomy — a design feature that is clinically significant for both treatment reproducibility and patient compliance.

Male and female regenerative sexual medicine clinical pathways
Male Sexual Health Pathway
Female Sexual Health Pathway
Male Sexual Health

Regenerative Protocols for Vascular, Fibrotic & Pelvic Dysfunction

Male

Erectile Dysfunction (ED)

Erectile dysfunction of vascular origin is the result of impaired arterial inflow and endothelial dysfunction in the penile microvasculature — the same pathological substrate addressed by Li-ESWT. Focused shockwaves applied to the corpus cavernosum and crura penis stimulate neoangiogenesis, restore endothelial function through eNOS upregulation, and activate Schwann cell proliferation in cases with neurogenic components.

The mechanism is not analgesic or symptomatic. Li-ESWT regenerates the vascular architecture of the penis — addressing the structural cause of ED rather than circumventing it. The clinical implications are significant: responders achieve functional erections without pharmacological support, and a meaningful subset of patients experience durable improvement beyond the active treatment course.

Clinical Evidence · Erectile Dysfunction · Multiple RCTs + Meta-Analyses

A systematic review of 14 studies (N=833) concluded that Li-ESWT “may have the potential to become the first-line non-invasive treatment for ED patients” (Lu et al., European Urology, 2016). A prospective RCT (Olsen et al., 2014) demonstrated that 57% of men treated with Li-ESWT achieved satisfactory erections without medication after therapy. An Australian open-label study (Chung, BJU International, 2015) reported IIEF-5 improvement ≥5 points in 60% of patients; 67% reported satisfaction level 4/5; 80% would recommend the treatment to others.

Male

Induratio Penis Plastica / Peyronie's Disease (IPP)

Peyronie's disease is an acquired fibrotic disorder of the tunica albuginea characterized by plaque formation, penile curvature, and pain during erection. It disproportionately impacts quality of life, sexual function, and psychological well-being, and is significantly underdiagnosed and undertreated in aesthetic and integrative medicine settings.

Focused shockwaves applied to the penile plaque activate fibroblast remodeling, promote fibrinolytic activity, and induce apoptosis of pathological myofibroblasts — the cellular mediators of plaque formation. Published data demonstrate measurable reduction in plaque volume, improvement in curvature angle, elimination of erection pain, and improved erectile function across a structured 5–8 week protocol.

Clinical Evidence · Induratio Penis Plastica · Prospective RCT + Long-Term Follow-Up

A prospective, randomized, double-blind, placebo-controlled study (Palmieri et al., European Urology, 2009; N=100) demonstrated that ESWT eliminates pain and significantly improves erectile function and quality of life at 12 and 24 weeks. A pilot study (Michel et al., Journal of Endourology, 2003) reported that erection pain disappeared in 15/17 patients after a 5-week protocol; 15 patients were able to achieve satisfactory intercourse post-treatment (vs. 6 pre-treatment). A 2017 systematic review (Fojecki et al., World Journal of Urology) confirmed ESWT eliminates pain in IPP patients.

Male

Chronic Pelvic Pain Syndrome (CPPS)

Chronic pelvic pain syndrome in men — also classified as chronic abacterial prostatitis (Category IIIB) — is characterized by persistent perineal and pelvic pain, voiding symptoms, and sexual dysfunction. It affects predominantly men between 35 and 45 years and remains one of the most challenging conditions to manage pharmacologically, with significant impact on quality of life and sexual function.

Li-ESWT applied perineal to the prostate and pelvic floor targets the inflammatory and neurogenic components of CPPS through two complementary mechanisms: hyperstimulation of pain receptors, blocking afferent pain transmission; and modulation of central pain sensitization. The non-invasive protocol is repeatable, has no documented side effects, and demonstrates clinical durability across multiple follow-up assessments.

Clinical Evidence · CPPS · RCTs with Active vs. Placebo Control

A randomized, double-blind, placebo-controlled study (Zimmermann et al., European Urology, 2009) demonstrated statistically highly significant improvement in pain, quality of life, and urinary conditions in the ESWT group versus placebo. Results of a further RCT (Vahdatpour et al., ISRN Urology, 2013) and a 2016 systematic review (Fojecki et al., World Journal of Urology) confirmed ESWT as a safe and effective short-term treatment for CPPS.

Female Sexual Health

Non-Invasive Pathways for Chronic Vulvar & Sexual Pain

Female

Vulvodynia

Vulvodynia is defined as chronic vulvar pain or discomfort without identifiable cause. It is more common than clinical awareness reflects, significantly impacts sexual function and quality of life, and is notoriously resistant to pharmacological management. The DUOLITH® SD1 T-TOP »ultra« offers a non-pharmacological, repeatable, evidence-based treatment approach backed by prospective randomized controlled data.

Focused ESWT applied to the vulva and perineum blocks nociceptive afferent transmission through hyperstimulation analgesia and modulates central sensitization at the level of the spinal dorsal horn. The clinical result is a durable reduction in pain perception — not temporary masking, but neurological recalibration that persists through post-treatment follow-up.

Clinical Evidence · Vulvodynia · Prospective RCT, Placebo-Controlled

A prospective, randomized, double-blind, placebo-controlled study (Hurt et al., European Journal of Physical and Rehabilitation Medicine, 2020; N=61) demonstrated pain reduction >30% in the treatment group using VAS, with large effect size (VAS: 0.883). Pain reduction was sustained at all follow-up assessments (1, 4, and 12 weeks post-treatment). No significant differences observed in the placebo group.

Female

Dyspareunia

Dyspareunia — pain during or after sexual intercourse — is a distressing and prevalent condition with multiple etiologies including provoked vestibulodynia, vulvar atrophy, and pelvic floor hypertonicity. It significantly impairs sexual health, relational wellbeing, and quality of life, and is frequently undertreated due to limited non-invasive options in clinical practice.

Focused ESWT applied to the perineum and vulvar vestibule targets the peripheral nociceptive and neurogenic mechanisms underlying dyspareunia, modulating C-fiber and Aδ-fiber afferent pain signaling and reducing local inflammatory mediator activity. The same research group that validated ESWT for vulvodynia extended their protocol to dyspareunia with equivalent results.

Clinical Evidence · Dyspareunia · Prospective RCT, Placebo-Controlled

A prospective, randomized, double-blind, placebo-controlled study (Hurt et al., Annals of Physical and Rehabilitation Medicine, 2021; N=61) reported pain reduction >30% in the ESWT group using both VAS and Marinoff Dyspareunia Scale. Marinoff Scale effect size: 0.825. Results were sustained across all follow-up time points (1, 4, and 12 weeks post-treatment).

Clinical Protocols

Structured Male & Female Treatment Pathways

Sexual Medicine — Male Protocol

ED / IPP / CPPS

6–12 sessions of 15–20 minutes, weekly. SEPIA® handpiece with anatomically shaped stand-off applied to corpus cavernosum, crura, and perineum. Can be combined with PRP, hormone optimization, and lifestyle protocols.

Sexual Medicine — Female Protocol

Vulvodynia / Dyspareunia

4–6 weekly sessions of ~15 minutes. SEPIA® handpiece applied to vulvar and perineal regions. Non-invasive, no sedation required, no downtime. Can be combined with PRP, topical, and pelvic floor protocols.

Regenerative Synergy

Combination with PRP / Biologic Therapies

Focused ESWT and platelet-rich plasma (PRP) share complementary mechanisms and produce synergistic outcomes when combined. ESWT increases tissue vascularity and cell membrane permeability before PRP application, significantly enhancing platelet activation, growth factor distribution, and biological uptake at the treatment site. For practices offering ENDORET® PRP through Evoskin, the DUOLITH® SD1 T-TOP »ultra« creates the optimal tissue environment for PRP delivery in sexual medicine protocols.

The combination of focused ESWT + PRP is increasingly considered the standard of care in regenerative sexual medicine protocols for ED.

Focused ESWT and PRP regenerative synergy
The SEPIA® Handpiece — Technical Specifications

Storz Medical · Focused Electromagnetic Shockwave Handpiece

The SEPIA® handpiece is the clinical core of the DUOLITH® SD1 T-TOP »ultra« platform. For sexual medicine (URO) applications, it is fitted with an anatomically shaped stand-off designed for precise, comfortable adaptation to pelvic and genital anatomy — a design feature that is clinically significant for both treatment reproducibility and patient compliance. Frequency, energy level, and pulse count are adjustable directly on the handpiece, keeping the clinician's attention at the patient rather than a console.

SEPIA focused shockwave handpiece and stand-off accessories
ParameterSpecification
Wave typeFocused electromagnetic shockwave
Focal zone depth0 – 65 mm (mechanically adjustable via stand-off accessories)
Therapeutic penetrationUp to 125 mm
Energy range0 – 0.55 mJ/mm² (sexual medicine protocols run at the lower end of this range)
ControlsFully integrated into handpiece display (frequency, energy, pulse count)
Stand-off systemAnatomically shaped stand-off for sexual medicine (URO) applications
CompatibilityCompatible with all DUOLITH® SD1 »ultra« system configurations
Optional 10" touchscreenUSB-connected tablet with patient management, protocol library with videos + images, Visible Body® digital anatomy atlas
Clinical Evidence Summary

The Published Evidence Base for Sexual Medicine

The following is a condensed reference for the most clinically relevant published work in sexual medicine covered in this document.

IndicationKey Evidence
Erectile Dysfunction (ED)Multiple systematic reviews and meta-analyses confirm efficacy. Li-ESWT named potential “first-line non-invasive treatment” (Lu et al., Eur Urol, 2016). 57% of patients achieved erection without medication (Olsen et al., 2014). IIEF-5 improvement ≥5 points in 60% of patients (Chung, BJU Int, 2015).
Peyronie's Disease (IPP)Prospective RCT: significant improvement in VAS pain, IIEF-5, and QoL at 12 and 24 weeks (Palmieri et al., Eur Urol, 2009). Pain resolved in 15/17 patients; 15/24 achieved satisfactory intercourse post-treatment (Michel et al., 2003). 2017 systematic review confirms pain elimination (Fojecki et al.).
CPPS — MaleRandomized, double-blind, placebo-controlled study: highly significant improvement in pain, QoL, and urinary conditions (Zimmermann et al., Eur Urol, 2009). Confirmed by Vahdatpour et al. (ISRN Urology, 2013) and a 2016 systematic review (Fojecki et al.).
VulvodyniaProspective RCT: VAS pain reduction >30%, large effect size (0.883). Sustained at 1, 4, and 12 weeks post-treatment (Hurt et al., EJPRM, 2020; N=61).
DyspareuniaProspective RCT: Marinoff Scale reduction >30%, effect size 0.825. Sustained at all follow-up time points (Hurt et al., Annals of Physical and Rehabilitation Medicine, 2021; N=61).
Full bibliographic details (author initials, volume, issue, and page numbers) have not been reproduced here and should be confirmed directly against the Storz Medical Shock Wave Portal (shockwaveportal.com) or the Evoskin clinical resources library before use in any patient- or investor-facing material.
Global Leadership

The Device of Record in Evidence-Based Sexual Medicine

Li-ESWTPlatform of record for peer-reviewed sexual medicine data
FocusedEnergy that converges precisely at depth
Non-InvasiveNo sedation, no downtime
Dual ProtocolValidated male & female pathways
DUOLITH SD1 T-TOP ultra system for regenerative sexual medicine
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Contact Evoskin to schedule a DUOLITH® SD1 T-TOP »ultra« demonstration, discuss financing, or enroll in Evoskin Academy's regenerative sexual medicine training program.