External Erectile Prosthesis for Surgery (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)

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

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

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