Clinical Research & Evidence

Every treatment offered at Charlotte Men's Clinic is supported by published clinical research. This page provides plain-language summaries of the key studies behind our protocols — cited directly from peer-reviewed medical journals. All content is reviewed by Dr. David Croland.

Shockwave Therapy (Li-SWT)

Low-intensity shockwave therapy is one of the most extensively studied advanced treatments for erectile dysfunction. It stimulates neovascularization — the growth of new blood vessels — addressing the root vascular cause of ED.

Systematic Review & Meta-Analysis of 15 RCTs (2025) — Basic and Clinical Andrology

A meta-analysis of 15 RCTs found shockwave therapy produced a significant IIEF increase of 2.96 points (95% CI: 1.93–4.61, P < 0.001). Efficacy was greatest with two weekly sessions and at least 6,000 pulses per session.

Bayesian Network Meta-Analysis (2024) — International Journal of Impotence Research

This analysis evaluated optimal treatment parameters across multiple RCTs. Higher-energy protocols showed superior IIEF improvement, supporting individualized protocols.

Stratified Efficacy Analysis by ED Severity (2025) — African Journal of Urology

Shockwave therapy was effective across mild, moderate, and severe ED, with the strongest response in vasculogenic cases.

Platelet-Rich Plasma (The P-Shot®)

PRP therapy uses concentrated growth factors from the patient's own blood to stimulate tissue regeneration. The strongest results emerge from combination protocols pairing PRP with shockwave therapy.

Prospective RCT (2024) — Basic and Clinical Andrology

A prospective RCT demonstrated significant improvements in erectile function scores with intracavernosal PRP injections and confirmed an excellent safety profile.

Meta-Analysis of PRP Alone and Combined with Li-SWT — 7 RCTs (2025) — The Aging Male

The first meta-analysis to evaluate PRP both standalone and combined with shockwave therapy. Combination therapy showed enhanced efficacy over either treatment alone.

Prospective Combination Study (2025) — ICS-EUS / University of Miami

A prospective study evaluating shockwave therapy combined with leukocyte-poor PRP, contributing to the growing evidence for multi-modal regenerative protocols.

Botulinum Toxin for ED

Intracavernosal botulinum toxin relaxes penile smooth muscle to improve blood flow — particularly promising for men who have not responded to PDE5 inhibitors.

RCT — BoNT-A for PDE5i-Refractory ED (Ghanem et al., 2021) — Andrology

70 men with PDE5i-refractory ED. At 6 weeks, 53% of treated patients achieved erections sufficient for penetration vs. 3% placebo. 5-point SHIM improvement. No serious adverse events.

Phase 2 RCT — IncobotulinumtoxinA + Sildenafil (2025) — Journal of Sexual Medicine

165-patient multicenter trial. Excellent safety profile confirmed. Adjusted analysis of adherent patients showed significant IIEF improvement (P = 0.032).

Comprehensive Systematic Review (2024) — Life (MDPI)

Review of all published intracavernosal botulinum toxin studies confirmed consistent mechanism of action and favorable safety across all studies.

Testosterone Replacement Therapy (TRT)

Landmark clinical trials including the TRAVERSE trial (NEJM, 2023) have fundamentally shifted understanding of TRT safety and efficacy.

TRAVERSE Trial (2023) — New England Journal of Medicine

5,246 men followed for 33 months. No increase in major adverse cardiac events (HR 0.96).

TRAVERSE Prostate Substudy (2024) — JAMA Network Open

5,204 men over 14,304 person-years. No significant difference in prostate cancer between TRT and placebo.

Meta-Analysis of 28 RCTs (2024) — Frontiers in Endocrinology

TRT significantly improved IIEF erectile function scores by 3.26 points (P < 0.0001).

For a comprehensive, myth-by-myth analysis: TRT Myths vs. Facts

Contact Charlotte Men's Clinic: (704) 850-6030