FirmTech User Research Trial

Reproductive Medicine Associates of New Jersey

Status: Completed

Conditions: Erectile Function

Treatments: Other: FirmTech Tech Ring; Other: Giddy Penile Constriction Ring

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05853822

Firmtech_RMANJ_01

Details and patient eligibility

About

The objective of this study is to see whether a home-use penile constriction device, Firmtech Tech Ring, can be determined to be superior to the Giddy device through evaluation of Leikert scale scores to assess ease of use and participant comfort and satisfaction with erectile quality with these devices. The primary outcome will be the satisfaction with use of the device as assessed through the Leikert scores. The other outcomes will be secondary.

Enrollment: 51 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All English-speaking participants > 18 years old recruited through social media.
• Physically and emotionally capable of engaging in sexual activity with at least one attempt per week of masturbation or sexual intercourse

Exclusion criteria

• Men who cannot understand English.
• Men with a prior or current penile implant.
• Transgender or non-binary individuals
• Men diagnosed with a hidden or buried penis.
• Investigator's impression of expected poor participant compliance or anatomic inadequacy (penile size/girth)
• Any psychiatric disorder, which, in the opinion of the investigator, would prohibit participation.
• Coagulopathy or other blood disorder which the investigator determines would affect the participant's participation in the trial.
• Any tumor in the pelvic or penile region within the last 3 years
• Men with an active caregiver who are unable to live independently.
• Men who the provider is concerned would be at high risk for non-healing wounds of the penis.
• Participants with sensory disorders like sensory processing disorder, sensory integration dysfunction disorder, neuropathies, etc.