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External Erectile Device
Use of an External Erectile Device in Transgender Man Following Phalloplasty (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
No Placebo-Only Group
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
- Surgery
- Transgender
- Sexual Activity
- Erectile Dysfunction
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and at study completion (~1.5 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at study completion (~1.5 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Quality of Sexual Experience Scale
Change in Relationship Satisfaction Subscale
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)
Secondary study objectives
Qualitative Device Feedback
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
789 Previous Clinical Trials
5,582,891 Total Patients Enrolled
2 Trials studying Surgery
5,000,100 Patients Enrolled for Surgery