FirmTech User Research Trial

NCT05853822 | Completed

• 1 other identifier: Firmtech_RMANJ_01
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Function

Outcome Measures

Primary Outcomes (1)

• Device satisfaction via Leikert scores

  A survey will be completed for each device after utilization

  2 weeks after receiving device

Interventions

FirmTech Tech Ring OTHER

Participants will utilize the FirmTech Tech Ring at least twice during a two-week time period and complete a survey

Giddy Penile Constriction Ring OTHER

Participants will utilize the Giddy Penile Constriction at least twice during a two-week time period and complete a survey

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample from social media recruitment

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reproductive Medicine Associates of New Jersey: lead
• FirmTech, Inc.: collaborator

Study Sites (1)

IVI RMA New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

Related Publications (1)

• Rendon DO, Saffati G, Whitehead C, Zuckerman C, Hom A, Daily R, Khera M, Cheng PJ. Penile constriction devices: a randomized survey study to compare preferences between two medical-grade devices. J Sex Med. 2025 Jan 3;22(1):43-50. doi: 10.1093/jsxmed/qdae151.

  PMID: 39545359 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 11, 2023
• Study Start: May 2, 2023
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2023
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)