FirmTech User Research Trial

Completed

• Conditions: Erectile Function

• Registration Number: NCT05853822
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-02
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-11
• Primary Completion: 2023-10-20
• Study Completion: 2023-10-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 51

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device satisfaction via Leikert scores	2 weeks after receiving device	A survey will be completed for each device after utilization

Trial Locations

Locations (1)

IVI RMA New Jersey; 🇺🇸 Basking Ridge, New Jersey, United States