Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons

NCT06639776 | Recruiting FDA Device

• 1 other identifier: ONZ-2023-0605
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore sexual satisfaction among transgender men and their partners following the placement of erectile prostheses after phalloplasty. While phalloplasty can create a neophallus, the lack of natural erectile tissue often necessitates the use of erectile aids, including internal prostheses. However, these prostheses, originally designed for cisgender men, face challenges when used in transgender patients, such as higher risks of complications, infections, and mechanical failures. Despite these issues, some studies report high patient satisfaction, though partner satisfaction rates are significantly lower. The study will use validated and non-validated questionnaires to assess satisfaction with various types of erectile prostheses, addressing the gap in understanding how these devices impact the sexual and relational functioning of both transgender men and their partners. These questionnaires will be provided to all included patients that are minimum 6 months after placement of an internal erection prosthesis and have a functional erection prosthesis in place

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; Genital reconstruction; Patient Reported Outcome Measures (PROMs)

Outcome Measures

Primary Outcomes (2)

• Treatment satisfaction

  Assessed using the Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire (EDITS) The EDITS provides two summative scores of 0-44 and 0-20 for patient and partner scores respectively. A higher score indicates a better treatment satisfaction. Higher scores indicate better outcome. With this questionnaire a number of subgroup analyses will be conducted. The obtained scores for treatment satisfaction for different types of erectile prostheses will be compared. Besides that, the difference in scores between patients and their partners will be explored. Another possible subgroup analysis will compare patients with different number of erectile prostheses placed. It was decided not to use a specific question from the EDITS patient questionnaire. It applies to the participant\'s erectile dysfunction which is not relevant to this study. The maximum score will therefore be 40.

  One-time questionnaire at least 6 months after erection prosthesis placement

• Capability of vaginal and/or anal penetration of the participant and sexual functioning

  Separate questions regarding penetration, sexual functioning and the experience of the patient and their optional partner are listed in the appendix for patient and their optional partner. Capability will be defined as full repetitive anal and/or vaginal penetration of the partner while using the prosthesis, which was not possible before 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. Patient and their optional partner indicate how desirable and/ or painful penetration was using a Likert slider question on a scale of 1 to 5.

  One-time questionnaire at least 6 months after erection prosthesis placement

Secondary Outcomes (5)

• Relationship satisfaction, sexual satisfaction, and quality of life

  One-time questionnaire at least 6 months after erection prosthesis placement

• Patient willing to undergo redo surgery and recommendation to other patients

  One-time questionnaire at least 6 months after erection prosthesis placement

• • Use of previous external devices or aids before placement of an erectile prosthesis

  One-time questionnaire at least 6 months after erection prosthesis placement

• Lower urinary tract symptoms (LUTS) and their impact on quality of life.

  One-time questionnaire at least 6 months after erection prosthesis placement

• Prosthesis related complications.

  One-time questionnaire at least 6 months after erection prosthesis placement

Interventions

Questionnaire DIAGNOSTIC_TEST

All erection prosthesis placements in post-phalloplasty transgender and gender non-conforming individuals at Ghent University Hospital from start of the gender clinic until June 2023 will be evaluated. All patients that are at least 6 months after erection prosthesis placement and currently have a functioning prosthesis in place are eligible and will be contacted. Upon inclusion and informed consent, the patient's medical files will be used to gather all necessary underlying medical information that is relevant to this study. will receive an email asking them to complete a questionnaire for themselves. At the end of this questionnaire the patient will be asked if they have a sexual partner and if this partner is willing to participate as well. After affirmation, the partner will be contacted in the same way. Patients will receive a series of questionnaires reviewing recent sexual activity, sexual preference, satisfaction with the erectile prosthesis and quality partner relationship.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post-phalloplasty transgender patients that have undergone erectile prosthesis placement at the Ghent University Hospital at least six months ago and in whom the erection prosthesis in place in functioning.

You may qualify if:

• Patient and partner age ≥ 18 years.
• 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 (any type of flap combination or technique is allowed).
• Erection prosthesis placement ≥ 6 months after phalloplasty, performed at the Ghent University Hospital. Any type of prosthesis is allowed.
• Patient is Dutch, English or French speaking.
• Voluntary signed and written consent by patient and their optional partner.

You may not qualify if:

• Patient age \< 18 years.
• Cisgender patients treated with phalloplasty and/or erection prosthesis for various reasons.
• The erection prosthesis has been explanted or the current prosthesis is nonfunctional at time of data assessment.
• Erection prosthesis placement \< 6 months before study start will be excluded.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Department of Urology, University Hospital Ghent

Ghent, East-Flanders, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

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

Interventions

Pain Measurement

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

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Anne-Françoise Spinoit, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wietse Claeys, MD

CONTACT

003293322276; wietse.claeys@ugent.be

Anne-Françoise Spinoit, MD, PhD

CONTACT

003293322276; anne-francoise.spinoit@uzgent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: October 15, 2024
• Study Start: July 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: July 31, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)