Efficacy of PV-MAX Exosome Therapy with Daily VED Use for Male Sexual Wellness — 3 Participant Series with 12-Week Follow-Up

1. Participant Selection

Inclusion criteria:
- Men aged 35–70 years
- Self-reported mild to moderate erectile dysfunction (IIEF-EF score 11–25)
- Stable relationship or consistent sexual partner
Exclusion criteria:
- Severe ED (IIEF-EF < 11)
- Active genital infection or Peyronie’s disease

- Use of PDE5 inhibitors within 7 days of treatment
- Uncontrolled diabetes mellitus or cardiovascular disease
- Anticoagulant therapy
- Prior penile surgery or implant

2. Pre-Treatment Preparation

- Informed consent obtained
- Penile skin disinfected with chlorhexidine
- Optional topical lidocaine or local penile block offered
- Baseline International Index of Erectile Function (IIEF) assessment and ultrasound

3. Treatment Protocol

- Product: PV-MAX exosomes, 1–2 mL total volume
- Injection technique:
- Intracavernosal injection at 10 and 2 o’clock positions of the corpora cavernosa
- Sterile technique throughout
- Adjunctive protocol:
- Daily VED therapy for 5 minutes, starting 24 hours post-injection, continued for 12 weeks
- No PDE5 inhibitors(Slidenafil, Cialis, Tadalafil ) during first 4 weeks unless otherwise instructed

4. Post-Procedure Care

- 15-minute observation post-injection for immediate adverse reactions
- Aftercare instructions:
- Expect mild soreness or bruising for 24–72 hours
- Avoid sexual activity for 24 hours post-injection
- No NSAIDs for 72 hours

5. Outcome Measures

Primary outcomes:
- Adverse events and tolerability at 12 weeks
- IIEF-EF score improvement from baseline with ultrasound
Secondary outcomes:
- Patient-reported erection quality and satisfaction (Global Assessment Questionnaire, GAQ)

- Frequency of successful intercourse attempts
- Global patient satisfaction at 12 weeks