Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639776
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons a Retrospective Cohort
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Gender dysphoria is defined as a discomfort or dissatisfaction because of a discordance between the individual39s assigned sex and their gender identity A national survey of transgender adults in the United States has shown that 39 of their respondents experience psychological distress which is eight times the rate in the United States population Transition-related treatment contains counseling psychotherapy hormone therapy and gender-affirming surgery depending on what the individual desires Gender-affirming surgery aims to change an individuals physical characteristics concordant with their gender identity and results in a reduction of psychological distress
A part of this population will eventually undergo genital gender affirming surgery GGAS to align the appearance of the external genitalia as well In transgender men GGAS can be performed as metoidioplasty or phalloplasty with or without the removal of the native external genitalia In metoidioplasty the goal is to create anatomically looking but undersized external genitalia in which the clitoris forms the base of a micro-penis In phalloplasty anatomically sized external genitalia phallus with or without urethra scrotum and perineum are created using on the one hand a donor skin flap and on the other hand tissues from the original genitals As there is no erectile tissue present in the neophallus after phalloplasty it is usually not possible to penetrate a sexual partner without the use of external or internal erectile aids In patients having undergone phalloplasty a multitude of methods for obtaining phallic rigidity are available One option can be the implantation of an internal erectile prosthesis
Most types of erectile prostheses used in the transgender community have originally been designed for cisgender men However implanting such a prosthesis in the neophallus presents a number of challenges due to the differences with the anatomy of a native penis As there are no cavernosal bodies with surrounding tunica albuginea that can be used as scaffold for anchoring of the prosthesis to the pubic bone there is an increased risk for distal extrusion malposition and extensive mobility during use Furthermore vascularization of the neophallus is largely dependent on the one or two vessels supplying the flaps resulting in relative hypovascularization delayed healing and an increased risk of infection Finally these types of prosthesis were originally made for an older population with erectile dysfunction Most transgender patients are younger and sexually more active which could lead to mechanical failure of the erectile prosthesis hence the life expectancy of implants is significantly reduced in this population Consequently penile implant surgery is associated with higher complications in a transgender population than in a cisgender population The revision rate or explantation rate within 4 years follow-up ranges from 376 to 44 in several studies Falcone et al reported that up to 22 of the prostheses was explanted within 20 months Within this study the patient and partner satisfaction were surveyed with a non-validated questionnaire Up to 88 of patients were completely satisfied with the outcome of the phalloplasty and the erectile prosthesis despite a significant complication rate However the partner satisfaction rate is significantly lower and rated at 60 Without further discussion Falcone et al stated that his result should be explored in the future
Recently the Swiss company Zephyr Surgical Implants created the ZSITM 475 female-to-male FTM Switzerland Europe the first erectile prosthesis specifically designed for transgender men after phalloplasty surgery It contains several functions such as a large base plate for pubic bone fixation a glans shaped tip and a testicle-shaped pump that have been conceived to answer several of the difficulties of prosthesis implantation Recent publications on this prosthesis continue to report high complication rates Verla et al reported postoperative complications in 32 of the patients Moreover 23 of the devices were explanted within 18 months follow-up due to distal cylinder protrusion infection malpositioning mechanical failure and urinary retention In the paper of Neuville et al the overall revision rate was 19 with a mean follow-up of 89 months resulting from infection mechanical failure and malpositioning However 928 of patients reported to be either satisfied or very satisfied with the erectile prosthesis and a mean EDITS score of 82 of 100
To date it is not possible to state which prosthesis is performing better in terms of complications and sexual satisfaction A more comprehensive questionnaire is needed to understand the reported satisfaction of the patient according to the different types of prosthesis As observed in the publication of Falcone et al the low partner satisfaction rate should be explored further as this may impact patients and partners relational functioning The current study aims to explore in more detail the sexual satisfaction in both transgender patients and their partners regarding erectile prosthesis placement using validated and non-validated questionnaires 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
A part of this population will eventually undergo genital gender affirming surgery GGAS to align the appearance of the external genitalia as well In transgender men GGAS can be performed as metoidioplasty or phalloplasty with or without the removal of the native external genitalia In metoidioplasty the goal is to create anatomically looking but undersized external genitalia in which the clitoris forms the base of a micro-penis In phalloplasty anatomically sized external genitalia phallus with or without urethra scrotum and perineum are created using on the one hand a donor skin flap and on the other hand tissues from the original genitals As there is no erectile tissue present in the neophallus after phalloplasty it is usually not possible to penetrate a sexual partner without the use of external or internal erectile aids In patients having undergone phalloplasty a multitude of methods for obtaining phallic rigidity are available One option can be the implantation of an internal erectile prosthesis
Most types of erectile prostheses used in the transgender community have originally been designed for cisgender men However implanting such a prosthesis in the neophallus presents a number of challenges due to the differences with the anatomy of a native penis As there are no cavernosal bodies with surrounding tunica albuginea that can be used as scaffold for anchoring of the prosthesis to the pubic bone there is an increased risk for distal extrusion malposition and extensive mobility during use Furthermore vascularization of the neophallus is largely dependent on the one or two vessels supplying the flaps resulting in relative hypovascularization delayed healing and an increased risk of infection Finally these types of prosthesis were originally made for an older population with erectile dysfunction Most transgender patients are younger and sexually more active which could lead to mechanical failure of the erectile prosthesis hence the life expectancy of implants is significantly reduced in this population Consequently penile implant surgery is associated with higher complications in a transgender population than in a cisgender population The revision rate or explantation rate within 4 years follow-up ranges from 376 to 44 in several studies Falcone et al reported that up to 22 of the prostheses was explanted within 20 months Within this study the patient and partner satisfaction were surveyed with a non-validated questionnaire Up to 88 of patients were completely satisfied with the outcome of the phalloplasty and the erectile prosthesis despite a significant complication rate However the partner satisfaction rate is significantly lower and rated at 60 Without further discussion Falcone et al stated that his result should be explored in the future
Recently the Swiss company Zephyr Surgical Implants created the ZSITM 475 female-to-male FTM Switzerland Europe the first erectile prosthesis specifically designed for transgender men after phalloplasty surgery It contains several functions such as a large base plate for pubic bone fixation a glans shaped tip and a testicle-shaped pump that have been conceived to answer several of the difficulties of prosthesis implantation Recent publications on this prosthesis continue to report high complication rates Verla et al reported postoperative complications in 32 of the patients Moreover 23 of the devices were explanted within 18 months follow-up due to distal cylinder protrusion infection malpositioning mechanical failure and urinary retention In the paper of Neuville et al the overall revision rate was 19 with a mean follow-up of 89 months resulting from infection mechanical failure and malpositioning However 928 of patients reported to be either satisfied or very satisfied with the erectile prosthesis and a mean EDITS score of 82 of 100
To date it is not possible to state which prosthesis is performing better in terms of complications and sexual satisfaction A more comprehensive questionnaire is needed to understand the reported satisfaction of the patient according to the different types of prosthesis As observed in the publication of Falcone et al the low partner satisfaction rate should be explored further as this may impact patients and partners relational functioning The current study aims to explore in more detail the sexual satisfaction in both transgender patients and their partners regarding erectile prosthesis placement using validated and non-validated questionnaires 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None