Use of an External Erectile Device in Transgender Man Following Phalloplasty (ProstHEsis)
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|ClinicalTrials.gov Identifier: NCT03823014|
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : July 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Transsexualism Surgery Sex Behavior Erectile Dysfunction||Device: Elator||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||July 2021|
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.
Measurement for device, use of device
Other Name: Erector
- 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
- Change in Relationship Satisfaction Subscale [ Time Frame: Baseline and at study completion (~1.5 months) ]Measure of overall relationship satisfaction with romantic partner
- 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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823014
|Contact: Elizabeth Boskey, Ph.D.||email@example.com|
|Contact: Divya Jolly, MAfirstname.lastname@example.org|
|United States, Massachusetts|
|Participation in this study is from participants home.||Recruiting|
|Somerville, Massachusetts, United States, 02145|
|Contact: Elizabeth R Boskey 617-919-6525 email@example.com|