This study aims to be the first to visualise changes in both clitoris and pelvic floor musculature following testosterone administration and to explore how these changes relate to sexual function. The primary objective of this observational study is…
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are clitoral and pelvic floor musculature volume
(expressed in mm3) and the percentage changes in volume (expressed in %)
between measurements prior to starting testosterone administration and after
nine months of treatment in transmasculine and gender-diverse persons.
Secondary outcome
Secondary endpoints are pelvic floor musculature volume and clitoral volume
(expressed in mm3) and percentage changes in clitoral volume (expressed in %)
during audiovisual sexual stimulation, self-reported feelings of sexual arousal
during audiovisual sexual stimulation, and sexual function assessed by an
adapted sexual function questionnaire.
Background summary
Gender-affirming hormone therapy for transmasculine and gender-diverse (TMGD)
persons assigned female at birth typically involves testosterone administration
to align physical traits with gender identity. Testosterone induces notable
changes in the pelvic and genital area, causing alterations in genital
microvasculature and sexual response. Clitoral hypertrophy is a
frequently-mentioned effect, but while external growth of the clitoris is
reported, no studies have quantified internal clitoral growth or its
relationship with androgens and sexual function. In addition to changes in the
clitoris, recent literature indicates that over 60% of TMGD persons experience
pelvic pain during sexual activity, with another study exploring a possible
link with changes in the pelvic floor musculature, which is known to be
androgen-sensitive. Again, the relation with sexual functioning is unclear.
Study objective
This study aims to be the first to visualise changes in both clitoris and
pelvic floor musculature following testosterone administration and to explore
how these changes relate to sexual function. The primary objective of this
observational study is to examine clitoral and pelvic floor musculature volume
and percentage changes in volume in transmasculine and gender-diverse persons
prior to start of testosterone administration and after nine months of
treatment. The secondary objectives are to examine pelvic floor musculature and
clitoral volume and percentage changes in clitoral volume during audiovisual
sexual stimulus and to explore the association between self-reported sexual
function and changes in clitoral and pelvic floor musculature volume.
Study design
This is an observational cohort pre-post study with non-invasive measurements.
Participants will complete questionnaires and undergo magnetic resonance
imaging (MRI) during two visits to Amsterdam UMC, location AMC. During these
visits, they will view a neutral and an erotic film segment while the MRI
measurements are taken.
Study burden and risks
As this study will provide important insights into the anatomical and
functional changes experienced by TMGD individuals initiating testosterone
therapy, successful completion will definitely have an impact within the fields
of sexual medicine and gender-diverse healthcare. Specifically, it will give
information on how testosterone affects both external and internal clitoral
structures, as well as the pelvic floor musculature. By using dynamic MRI to
visualize these changes (in response to sexual stimuli), we aim to fill gaps in
the knowledge on physiological changes associated with testosterone. The risks
associated with this study are small: they are related to possible intruding
questions and discomfort associated with genital MRI testing; through extensive
selection and preparation beforehand, chances of this research triggering
feelings of dysphoria will be kept at a minimal.
MRI itself is a non-invasive imaging modality. All participants will receive
extensive information about the MRI procedures and will be screened on
contra-indications beforehand. There will be minor discomfort caused by having
to lie still for several minutes and being fixed in a small space. Subjects
suffering from claustrophobia are therefore excluded from participation.
Considering the coaching and preparation beforehand, we consider the burden of
this procedure to be minimal. Since MR imaging is considered a safe standard
medical procedure, we evaluate the risks associated with MR scanning to be
negligible.
Altogether, this pilot study can offer data to healthcare providers that can
help them manage expectations and addressing sexual dysfunction in TMGD
individuals. As improved understanding of pelvic anatomical changes will lead
to more personalized care and more successful targeted interventions, it can
improve patient outcomes. Moreover, the study can serve as the foundation for
future research on sexual wellbeing in TMGD individuals. This is all the more
important within a minority community where existing data is sparse, while the
need for more knowledge is highly present in clinicians and patients alike.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a participant must meet
all of the following criteria:
• Transmasculine or gender-diverse persons assigned female at birth diagnosed
with gender dysphoria;
• Age >18 years;
• Scheduled to begin testosterone treatment within one to three months;
• Ability to provide written consent.
Exclusion criteria
A potential participant who meets any of the following criteria will be
excluded from participation in this study:
• Medical or mental conditions (acute or chronic) affecting genital response;
• History of hysterectomy, vaginal surgery, gynaecologic disease or malignancy,
pelvic inflammatory disease, vaginal infection, or anatomical variations such
as intersex conditions;
• Current pregnancy or recent delivery within the last 12 months;
• Self-reported genital dysphoria to the extent that participation is
undesirable.
• Contraindications to MRI, including pacemakers, metal implants, or severe
claustrophobia.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL88599.018.24 |