NCT05853822CompletedNot Applicable
FirmTech User Research Trial
Reproductive Medicine Associates of New Jersey1 site in 1 country51 target enrollmentStarted: May 2, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Device satisfaction via Leikert scores
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Device satisfaction via Leikert scores
Time Frame: 2 weeks after receiving device
A survey will be completed for each device after utilization
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Remote Participation (Within USA) Trial of Sana Pain RelieverNeuropathic PainChronic PainPainNCT04280562Icahn School of Medicine at Mount Sinai75
Completed
Not Applicable
Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley CatheterUrinary Tract InfectionsNCT00203515Tyco Healthcare Group1,000
Terminated
Not Applicable
Evaluation of an Incontinence ProductIncontinenceNCT03023072Hill-Rom9
Completed
Not Applicable
Strength for U in Relationship EmpowermentIPVPerinatalMental HealthNCT04218864Women and Infants Hospital of Rhode Island122
Withdrawn
Not Applicable
Urethral Catheter Immobilization Device to Reduce Catheter-Related DiscomfortUrinary Catheter-Related DiscomfortNCT03341468Massachusetts General Hospital