TranssexualismProstHEsisNCT03823014
Use of an External Erectile Device in Transgender Man Following Phalloplasty
A study testing Elator in people with Transsexualism and Surgery, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Transsexualism, Surgery, Sex Behavior
- What is being tested?
- Elator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Either subject or partner does not speak English
- Primary subject has an internal erectile prosthesis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Participation in this study is from participants home.
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Transsexualism, Surgery, Sex Behavior, Erectile Dysfunction
- Being tested
- Elator
- Keywords
- transgender, transmasculine, ftm, phalloplasty, penile prosthesis
- Medical subject headings
- Transsexualism, Sexual Behavior, Erectile Dysfunction, Meckel Syndrome, Type 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElatorDevice
Also called Erector
Measurement for device, use of device
| Study group | Role | What they receive |
|---|---|---|
| External Erectile Prosthesis | Experimental | 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. Receives: Device: Elator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Sexual Experience Scale
Brief measure of quality of most recent sexual experience
Measured: Baseline and at study completion (~1.5 months)
Change in Relationship Satisfaction Subscale
Measure of overall relationship satisfaction with romantic partner
Measured: Baseline and at study completion (~1.5 months)
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)
Validated measure of satisfaction with erectile dysfunction treatment
Measured: The intervention period of 4 weeks, assessed at study completion
Secondary outcomes (1)
Qualitative Device Feedback
Interview with men and their partners about the experience of using the device (optional)
Measured: The intervention period of 4 weeks, assessed at study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Jul 2019
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TranssexualismStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Boskey, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823014
- Sponsor's protocol ID
- IRB-P00029965
- Acronym
- ProstHEsis
- Status last verified
- Jul 2022
- First submitted
- 25 Jan 2019
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an External Erectile Device in Transgender Man Following Phalloplasty
- ClinicalTrials.gov ID
- NCT03823014
- Acronym / sponsor ID
- ProstHEsis / IRB-P00029965
- Conditions
- Transsexualism, Surgery, Sex Behavior, Erectile Dysfunction
- Keywords
- transgender, transmasculine, ftm, phalloplasty, penile prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| External Erectile Prosthesis | Experimental | Device: ElatorStudy 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Either subject or partner does not speak English
- Primary subject has an internal erectile prosthesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElatorAlso: ErectorMeasurement for device, use of device | Device | External Erectile Prosthesis |
Primary outcome
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
1 secondary outcome
Qualitative Device Feedback
Time frame: The intervention period of 4 weeks, assessed at study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elator in people with Transsexualism and Surgery, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Sexual Experience Scale (time frame: Baseline and at study completion (~1.5 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.