Clinical Data

 

ROBUST CLINICAL DATA

ALL FDA SUCCESS CRITERIA HAVE BEEN MET

 

Performance

 

Objective Criterion - Time Improvement Rate

Safety study results

Subjective Criterion - Sense of Improvement

feasibility1
 

Safety: 2 minor AE reported (1.08%)

Contraindications

Never use vPATCH if you:

  • have been diagnosed with, or are receiving treatment for, pelvic cancer
  • have an implanted electronic device
  • suffer from perineal dermatological diseases, irritations, or lesions

Warnings and Precautions

  • consult your physician if you:
    • experience any pain in the area
    • require any muscle rehabilitation in the area
  • do not apply the vPATCH to any area other than the male perineum
  • do not use if you have diabetes with peripheral neuropathy
  • do not use if you are receiving medical therapy or treatment for any disease or medical condition
  • do not use if you have had genital or anorectal surgery
  • the vPATCH is a single-patient device (do not transfer between patients)
  • potential adverse reactions include redness, discomfort, and localized pain
  • do not use the patch in water or in a humid environment (such as a jacuzzi, bath, shower, etc.)

Disclaimers

The vPATCH has not been tested on:

  • usage with a pregnant partner
  • users with past occurrences or ejaculation before vaginal penetration