Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT04993469
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2021-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient Reported Outcome on Genital Sensitivity and Sexual Function After Genital Gender Affirming Surgery
Sponsor:
University Hospital, Ghent
Organization:
Study Overview
Official Title:
Patient Reported Outcome on Genital Sensitivity and Sexual Function After Genital Gender Affirming Surgery
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROGAS
Brief Summary:
For genital gender affirming surgery, it remains unclear to what extent genital sensitivity might be expected and what the impact of this might be on sexual functioning.
Detailed Description:
Gender dysphoria refers to an inner mental unrest resulting from an incongruity between the assigned biological sex and the mentally experienced sex. The generally accepted treatment for gender dysphoria aims to bring a person's physical characteristics in line with his or her perceived gender identity. This gender-affirming treatment consists of a combination of psychological counselling, hormonal therapy and, if desired, genital gender-affirming surgery. This involves the removal of the biological reproductive organs and in some cases (part of) the biological sex organs. These can be replaced by surrogate sex organs of the desired sex while maintaining urological and sexual function. In transgender women, this is achieved with vulvoplasty or vaginoplasty, while in transgender men, metoidioplasty or phalloplasty is performed.
While urological functioning is an extensively studied topic in transgender patients after genital gender confirmation surgery, sexual functioning is often considered of secondary importance, even though it is one of the goals of gender confirmation surgery. In the transgender man, a phalloplasty is performed using microsurgical techniques that allow the nerves of the donor flap (usually from the forearm or upper leg) to be connected to the genital and inguinal nerves. In metoidioplasty, the clitoris is preserved and forms the base of a micro-penis. In the transgender woman, the glans penis is partially preserved to create a clitoris. The purpose of this is to achieve maximum sensitivity of the genital area.
There are few reports in the literature demonstrating sensory recovery in these extensively operated body parts, let alone what the added value on sexual functioning might be as a result of this recovery of genital sensitivity. At Ghent University Hospital, we now have more than 30 years' experience with such operations and have shared this experience in an almost entirely retrospective manner in various publications to date. However, in order to address the bias associated with retrospective research, this study aims to prospectively and observationally collect data on these patients who are counseled in a pathway for gender dysphoria. This study will include all patients - after informed consent - and will collect specific data on surgical outcome (complications after surgery, duration of surgery, type of surgery) and functional outcome (tailored questionnaires for patients undergoing such a treatment with questions on urination, erections, sexual experience, quality of life, patient satisfaction and genital sensitivity) for each of these various surgical options. These outcomes will be verified at follow-up moments (after 3 months, 6 months, 12 months and 24 months). Specifically for the component on genital sensitivity, we plan to follow up patients 3-monthly by means of a Semmes-Weinstein monofilament test of the genital region up to 24 months postoperatively. The aim of this study is therefore to use this prospectively collected data to truthfully map our experience, to be critical, to reflect and optimize our daily clinical practice in the interest of the patient.
While urological functioning is an extensively studied topic in transgender patients after genital gender confirmation surgery, sexual functioning is often considered of secondary importance, even though it is one of the goals of gender confirmation surgery. In the transgender man, a phalloplasty is performed using microsurgical techniques that allow the nerves of the donor flap (usually from the forearm or upper leg) to be connected to the genital and inguinal nerves. In metoidioplasty, the clitoris is preserved and forms the base of a micro-penis. In the transgender woman, the glans penis is partially preserved to create a clitoris. The purpose of this is to achieve maximum sensitivity of the genital area.
There are few reports in the literature demonstrating sensory recovery in these extensively operated body parts, let alone what the added value on sexual functioning might be as a result of this recovery of genital sensitivity. At Ghent University Hospital, we now have more than 30 years' experience with such operations and have shared this experience in an almost entirely retrospective manner in various publications to date. However, in order to address the bias associated with retrospective research, this study aims to prospectively and observationally collect data on these patients who are counseled in a pathway for gender dysphoria. This study will include all patients - after informed consent - and will collect specific data on surgical outcome (complications after surgery, duration of surgery, type of surgery) and functional outcome (tailored questionnaires for patients undergoing such a treatment with questions on urination, erections, sexual experience, quality of life, patient satisfaction and genital sensitivity) for each of these various surgical options. These outcomes will be verified at follow-up moments (after 3 months, 6 months, 12 months and 24 months). Specifically for the component on genital sensitivity, we plan to follow up patients 3-monthly by means of a Semmes-Weinstein monofilament test of the genital region up to 24 months postoperatively. The aim of this study is therefore to use this prospectively collected data to truthfully map our experience, to be critical, to reflect and optimize our daily clinical practice in the interest of the patient.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: