FirmTech User Research Trial

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.

Study Overview

• Status: Completed
• Conditions: Erectile Function
• Intervention / Treatment: Other: FirmTech Tech Ring; Other: Giddy Penile Constriction Ring

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • IVI RMA New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Community sample from social media recruitment

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device satisfaction via Leikert scores	A survey will be completed for each device after utilization	2 weeks after receiving device

Collaborators and Investigators

• Sponsor: Reproductive Medicine Associates of New Jersey
• Collaborators: FirmTech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Actual): October 20, 2023
• Study Completion (Actual): October 20, 2023

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Firmtech_RMANJ_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No