NCT03823014

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

January 25, 2019

Last Update Submit

July 20, 2022

Conditions

TranssexualismSurgerySex BehaviorErectile Dysfunction

Keywords

transgendertransmasculineftmphalloplastypenile prosthesis

Outcome Measures

Primary Outcomes (3)

  • Change in Quality of Sexual Experience Scale

    Brief measure of quality of most recent sexual experience

    Baseline and at study completion (~1.5 months)

  • Change in Relationship Satisfaction Subscale

    Measure of overall relationship satisfaction with romantic partner

    Baseline and at study completion (~1.5 months)

  • Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)

    Validated measure of satisfaction with erectile dysfunction treatment

    The intervention period of 4 weeks, assessed at study completion

Secondary Outcomes (1)

  • Qualitative Device Feedback

    The intervention period of 4 weeks, assessed at study completion

Study Arms (1)

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.

Device: Elator

Interventions

ElatorDEVICE

Measurement for device, use of device

Also known as: Erector
External Erectile Prosthesis

Eligibility Criteria

Age18 Years - 64 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsTransgender men and their sexual partners (no gender/sex requirement)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Participation in this study is from participants home.

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

TranssexualismSexual BehaviorErectile DysfunctionMeckel Syndrome, Type 5

Condition Hierarchy (Ancestors)

SexualityBehaviorGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 30, 2019

Study Start

July 1, 2019

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)