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External Erectile Device

External Erectile Prosthesis for Transgender (ProstHEsis Trial)

N/A
Waitlist Available
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at study completion (~1.5 months)
Awards & highlights

Summary

This trial tests if The Elator™, a device with silicone rings and rigid rods, can help transgender men who have had phalloplasty use their new penis for sex. The device supports the penis to keep it firm, offering a non-surgical alternative to internal erectile devices. The Elator is being tested as an external erectile prosthesis for transgender men who have undergone phalloplasty.

Eligible Conditions
  • Transgender
  • Surgery
  • Sexual Activity
  • Erectile Dysfunction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at study completion (~1.5 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at study completion (~1.5 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Quality of Sexual Experience Scale
Change in Relationship Satisfaction Subscale
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)
Secondary outcome measures
Qualitative Device Feedback

Trial Design

1Treatment groups
Experimental Treatment
Group I: External Erectile ProsthesisExperimental Treatment1 Intervention
Study participants will be recruited as couples (transgender man + sexual partner.) Couples will use an external erectile prosthesis (Elator) over the course of 1 month and keep track of their experiences. 20 men and their partners will be enrolled.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elator
2019
N/A
~20

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Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
773 Previous Clinical Trials
5,580,936 Total Patients Enrolled
~2 spots leftby Sep 2025
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