FirmTech User Research Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-02

Study Completion Date

2023-10-20

Brief Summary

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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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Detailed Description

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Conditions

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Erectile Function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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FirmTech Tech Ring

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

Intervention Type OTHER

Giddy Penile Constriction Ring

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No