Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.

NCT05883553 | Recruiting

• 1 other identifier: ONZ-2023-0121
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

Brief Summary

Transgender and gender diverse (TGD) individuals most often choose for phalloplasty as a means to create masculine external genitalia. The neophallus created in phalloplasty is usually insufficient for penetrative sexual intercourse due to the lack of erectile structures. Therefore, implantation of an internal erectile prosthesis or use of an external device or epithesis is required. Internal prostheses are the main method for attaining penile rigidity after phalloplasty, but they carry a high risk of complications. Previous research has shown that up to 22% of prostheses for cisgender men were explanted due to various reasons, including infection, erosion, and malfunction within 20 months. The lack of reliable and durable erectile devices leads to a large proportion of patients either choosing phalloplasty but never going for the placement of an erectile prosthesis or completely abandoning the idea of GGAS under the form of phalloplasty. Secondarily, TGD individuals may be concerned about complication rates and likely need for additional surgeries associated with penile implant surgery. Therefore, alternative options for transgender and gender non-conforming patients after phalloplasty are needed. These alternatives may be surgical or non-surgical. External penile epitheses or penile splints were originally designed for cisgender men with erectile dysfunction but have been used experimentally by post-phalloplasty transgender men. While there is no data on the usability and durability of penile epitheses in a TGD population, they may be a viable alternative to an internal penile prosthesis after phalloplasty. Penile lifters or splints, marketed as ElatorTM or ErektorTM, are commercially available and consist of two rigid rings connected by rigid metal rods. The biggest of two rings is placed around the base of the phallus, and the second ring is placed behind the coronal ridge. By connecting the rods to the ring at the base of the penis, tension and rigidity between the two rings is created, allowing the user to penetrate their partner and remove the device after intercourse. The current study aims to extend the knowledge on these external devices by comparing them to the implantation of an internal penile prosthesis in post-phalloplasty transgender patients.

Conditions

Transgenderism; Erectile Dysfunction; Prosthesis Durability; Gender Dysphoria; Sexual Dysfunction

Keywords

Gender dysphoria; Transgender; Phalloplasty; Erectile dysfunction; Sexual function; Erection prosthesis; Penile epithesis; Medical device; Penile splint; Patient Reported Outcome Measures (PROMs); Genital reconstruction; Reconstructive urology

Outcome Measures

Primary Outcomes (2)

• Percentage of patients choosing either for the prosthesis or the epithesis at the start of study

  At baseline, patients will get information on both the prosthesis and the epithesis and will be free to choose between them. This difference in percentage and the reasons for choosing between either will be noted.

  Baseline assessment

• Difference in capability rate of vaginal and/or anal penetration of the participant's partner

  * Capability will be defined as full repetitive anal and/or vaginal penetration of the partner while using the epithesis or prosthesis, which was not possible before use or implantation, without pain to patient and/or partner, until the end of the intended sexual intercourse. * If penetration is not possible, the reasons for this incapacity will be noted

  Baseline questionnaire, followed by reassessment at 1 and 4 months after study start

Secondary Outcomes (8)

• Interest in continued use of epithesis by both patient and partner

  Assessment at 4 months after study start

• Difference in quality of sexual experience

  Baseline questionnaire, followed by reassessment shortly after sexual activity. To be filled out by patient and partner at least once per month during the 4 months of the study period

• Difference in treatment satisfaction

  Assessment at 1 and 4 months after study start

• Difference in relationship satisfaction

  Baseline questionnaire, followed by reassessment at 1 and 4 months after study start

• Difference in lower urinary tract symptoms

  Baseline questionnaire, followed by reassessment at 1 and 4 months after study start

Study Arms (2)

Epithesis group

EXPERIMENTAL

Participants receive an Elator device which was measured to the size of their phallus.

Device: Usability and added value of device within sexual activity

Prosthesis group

ACTIVE COMPARATOR

Participants receive a Zephyr ZSI 475 FTM internal erection prosthesis device as the current standard of care in our hospital. A healing phase of at least six weeks is respected.

Device: Usability and added value of device within sexual activity

Interventions

Usability and added value of device within sexual activity DEVICE

Participants and there partners will be asked to use the device over the course of 4 months, during which both will provide answers to questionnaires on quality of relation and sexual life, and detailed questions on the usability and the added value of the used device during sexual activity along with overall satisfaction with the device.

Epithesis group; Prosthesis group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Transgender or gender non-conforming individuals diagnosed according to the DSM-5 diagnostic criteria for gender dysphoria.
• Patients have undergone phalloplasty as a form of genital gender affirming surgery.
• ≥ 1 year after phalloplasty (any type of flap combination is allowed), performed at the Ghent University Hospital or Amsterdam UMC.
• ≥ 3 months after coronaplasty and having reasonably pronounced coronal ridge, as defined by the surgeons' expert opinion (This criterion is only obligatory in the eptithesis group, not in the prosthesis group).
• Anatomic penile length and girth as defined by the surgeons' expert opinion.
• Absence of urethral stricture or other structural problem resulting in voiding dysfunction.
• Normal uroflowmetry and post-void residue
• Regain of at least minimal protective sensation up to the tip of the phallus as defined by Semmes-Weinstein monofilament testing.
• Established (primary) sexual relationship with partner who is willing to take part in the study.
• Both patient and partner have interest in penetrative sexual intercourse.
• Patient is unable to penetrate the partner (anal or vaginal) adequately sexually without the aid of supportive measures (condom, taping, penile sleeve, penile epithesis or any other measure defined as supportive by the investigators).
• Fit and eligible for erection prosthesis surgery, based on the surgeons' expert opinion.
• No history of erection prosthesis surgery.
• No interest in or fear of prosthesis surgery making this option obsolete (This criterion is only obligatory in the eptithesis group, not in the prosthesis group)
• Treatment naïve in the use of the Elatortm or Erektortm epithesis.

You may not qualify if:

• Cisgender patients treated with phalloplasty various reasons.
• Post-metoidioplasty patients (metoidioplasty as step-up to performed phalloplasty is allowed).
• Absence of coronaplasty or coronaplasty performed \< 3 months ago or coronaplasty did not leave sufficiently pronounced coronal ridge as defined by the surgeons' expert opinion (This criterion is only obligatory in the epithesis group, not in the prosthesis group)
• Penile dimensions are not anatomic (e.g. too small or too large).
• Underlying LUTDs requiring further investigation and/or treatment.
• Inadequate protective sensation in the penis.
• No established (sexual) partner and/or partner is not willing to take part in the study.
• Patient and/or partner have no interest in penetrative sexual intercourse.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• ELATOR/EREKTOR: collaborator

Study Sites (2)

Department of Urology, University Hospital Ghent

Ghent, East-Flanders, 9000, Belgium

RECRUITING

Department of Urology, Amsterdam University Medical Center

Amsterdam, North Holland, 1081, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Transsexualism; Erectile Dysfunction; Prosthesis Failure; Gender Dysphoria; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolaas Lumen, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolaas Lumen, MD, PhD

CONTACT

003293322276; Nicolaas.Lumen@UZGent.be

Wietse Claeys, MD

CONTACT

003293322276; Wietse.Claeys@UGent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-inferiority parallel cohort study

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: June 1, 2023
• Study Start: May 17, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); NL (1)