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Completed

NCT Number: NCT05853822

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.

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Key information

Conditions

Erectile Function

Age range

18 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

IVI RMA New Jersey

Basking Ridge, New Jersey, 07920, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Device satisfaction via Leikert scores

    Time frame: 2 weeks after receiving device

    A survey will be completed for each device after utilization

Sponsors and collaborators

Lead sponsor

Reproductive Medicine Associates of New Jersey

Other

Collaborators

  • FirmTech, Inc.

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 11, 2023
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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