Use of an External Erectile Device in Transgender Man Following Phalloplasty (ProstHEsis)

• ClinicalTrials.gov Identifier: NCT03823014
• Recruitment Status: Completed
• First Posted: January 30, 2019
• Last Update Posted: July 21, 2022
• Sponsor: Boston Children's Hospital
• Information provided by (Responsible Party): Elizabeth Boskey, Boston Children's Hospital

Study Description

Brief Summary:

The purpose of this study is to test whether an external erectile prosthesis (The Elator™) is a feasible alternative to internal erectile prostheses for transgender men who have undergone a phalloplasty with glansplasty and wish to use their neophallus for sexual penetration. The Elator™ was initially developed for men experiencing erectile dysfunction after prostate cancer. The device consists of two silicone rings connected by a pair of plastic coated rigid metal rods. One ring goes at the base of the penis. The other ring is connected to the rods. This ring is placed behind the glans, and then the rods are connected to the base ring to stretch and provide rigidity to the phallus.

Condition or disease	Intervention/treatment	Phase
Transsexualism; Surgery; Sex Behavior; Erectile Dysfunction	Device: Elator	Not Applicable

Detailed Description:

There are approximately 1.4 million transgender adults in the United States. Approximately half are transgender men, individuals who have a male gender identity but were assigned female at birth. A national survey of transgender adults found more than half of transgender men have had, or may want, gender affirmation surgery in the form of phalloplasty - the surgical creation of a penis and scrotum. The neophallus created in this manner can be used for standing urination but not for penetrative sex, due to the lack of erectile structures.

Research suggests that one factor limiting interest in phalloplasty is the lack of reliable, durable, and desirable erectile devices. Internal prostheses are the primary method used to attain penile rigidity after phalloplasty. However, these devices carry a significant risk of mechanical failure and other adverse events. The high failure and complication rates associated with internal erectile prostheses demonstrate a need for alternative options for transgender men after phalloplasty. One such option consists of an external erectile prosthesis or support. The Elator™ consists of two silicone rings connected by a pair of plastic coated rigid metal rods. Use of such an external device may be preferable for men who do not wish to undergo additional surgery after phalloplasty, and/or those who have had problems with internal prostheses.

Word of mouth suggests that a number of transgender men have experimented with these devices after phalloplasty, but to date no study has tested the safety and function of external erectile prostheses in this population. Currently, the FDA exempts most external penile rigidity devices from pre-market notification and review. As such, safety and efficacy testing is not required prior to public marketing. However, before medical professionals can feel comfortable recommending these devices to their patients, such testing is clearly indicated.

The proposed pilot study will test whether an external erectile prosthesis (The Elator™) is a feasible alternative to internal erectile prostheses for transgender men after phalloplasty. This study will recruit twenty men who have had a phalloplasty greater than one year prior to the study date, have protective sensation to the tip of their phallus, have a current sexual partner with whom they would like to explore sexual penetration using the neophallus, and who do not currently have an internal erectile prosthesis.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Pilot study to determine feasibility of device use for supportive care of transgender patients with erectile concerns post phalloplasty. Device is currently available in market.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Use of an External Erectile Device in Transgender Man Following Phalloplasty
• Actual Study Start Date: July 1, 2019
• Actual Primary Completion Date: July 1, 2022
• Actual Study Completion Date: July 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: External Erectile Prosthesis; 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.	Device: Elator; Measurement for device, use of device; Other Name: Erector

Outcome Measures

Primary Outcome Measures :

1. Change in Quality of Sexual Experience Scale [ Time Frame: Baseline and at study completion (~1.5 months) ]
   Brief measure of quality of most recent sexual experience
2. Change in Relationship Satisfaction Subscale [ Time Frame: Baseline and at study completion (~1.5 months) ]
   Measure of overall relationship satisfaction with romantic partner
3. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) [ Time Frame: The intervention period of 4 weeks, assessed at study completion ]
   Validated measure of satisfaction with erectile dysfunction treatment

Secondary Outcome Measures :

1. Qualitative Device Feedback [ Time Frame: The intervention period of 4 weeks, assessed at study completion ]
   Interview with men and their partners about the experience of using the device (optional)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Transgender men and their sexual partners (no gender/sex requirement)
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Primary study subject must have had a phalloplasty with glansplasty a minimum of 1 year before enrollment and must have protective sensation to the tip of the phallus
• Primary study subject must be in a relationship in which they are having, or would like to have, penetrative sex with their partner. Partner must also be interested in having penetrative sex with primary subject.
• Both primary study subject and partner must have (individual) e-mail addresses and access to the Internet to complete surveys
• Primary study subject must be willing to be contacted by postal mail, in order to receive the device
• Both subjects must be willing to receive e-mails

Exclusion Criteria:

• Either subject or partner does not speak English
• Primary subject has an internal erectile prosthesis.

Contacts and Locations

Locations

United States, Massachusetts

Participation in this study is from participants home.

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Boston Children's Hospital

More Information

• Responsible Party: Elizabeth Boskey, Researcher, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT03823014
• Other Study ID Numbers: IRB-P00029965
• First Posted: January 30, 2019
• Last Update Posted: July 21, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elizabeth Boskey, Boston Children's Hospital:

transgender; transmasculine; ftm; phalloplasty; penile prosthesis

Additional relevant MeSH terms:

Erectile Dysfunction; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders