1. To generate initial data on whether a penile epithesis (ElatorTM) is a potential alternative to a penile prosthesis (ZSITM 475 FtM) in post-phalloplasty transgender individuals. 2. To assess participcant and partner expectations and experiences…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Erectiele functie, seksuele functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Percentage of participants choosing either for the prosthesis or the
epithesis at the start of study.
o At baseline, participants 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.
- Capability of vaginal and/or anal penetration of the participant*s partner at
1 and 4 months.
o 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 participant and/or partner, until
the end of the intended sexual intercourse.
o If penetration is not possible, the reasons for this incapacity will be noted
o These measures will be evaluated at 1 and 4 months after start of use and
compared between epithesis and prosthesis groups
Secondary outcome
- Feasibility of epithesis use by the participants.
o Feasibility will be defined as the proportion of participants in the
epithesis arm with interest in and willingness to continue use of the external
penile epithesis after the study period by both participant and partner.
- Quality of sexual experience (QSE) + specific questions added on experience
during diary entry.
o Quality of Sexual Experience questionnaire (15)
o The QSE provides a summative score between 7 and 49. A higher score indicates
a better sexual experience.
o At 1, 2, 3 and 4 months the difference between respectively 1m-, 2m-, 3m- and
4m-scores and the baseline score will be calculated. The changes in QEQ-scores
will be compared between epithesis and prosthesis groups in both participants
and their partners.
- Treatment satisfaction (EDITS) at 1 and 4 months.
o Erectile Dysfunction Inventory of Treatment Satisfaction (16)
o The EDITS provides two summative scores of 0-44 and 0-20 for participant and
partner scores respectively. A higher score indicates a better treatment
satisfaction. Higher scores indicate better outcome.
o At 4 months the differences in QEQ-scores will be compared between epithesis
and prosthesis groups in both participants and their partners.
- Relationship satisfaction, sexual satisfaction, and quality of life (MMQ) at
1 and 4 months.
o The Maudsley Marital Questionnaire (17)
o The MMQ provides three summative scores of 0-80, 0-40 and 0-40 on
relationship satisfaction, sexual satisfaction, and overall quality of life.
Lower scores indicate better outcome.
o At 1 and 4 months the difference between respectively 1m- and 4m-scores and
the baseline score will be calculated. The changes in MMQ-scores will be
compared between epithesis and prosthesis groups in both participants and their
partners.
- Lower urinary tract symptoms (ICIQ-MLUTS) at 1 and 4 months.
o International Consultation on Incontinence Questionnaire - Male Lower Urinary
Tract Symptoms module (18)
o The ICIQ-MLUTS module, consisting of 7 questions, provides a summative score
between 0 (asymptomatic) and 24 (most symptomatic) (question 1 - 6) and a
bother score between 0 (not bothersome) and 3 (very bothersome) (question 7).
o At 4 months, the difference between 4m-scores and the baseline score will be
calculated. The changes in ICIQ-MLUTS-scores will be compared between epithesis
and prothesis groups.
- Maximum flow rate (Qmax) at 1 and 4 months.
o The Qmax may only be interpreted is the voided volume exceeds 150ml. Flow
rated based on smaller volumes will be considered invalid and will the excluded
from further analysis.
o At 1 and 4 months the difference between 1m and 4m Qmax measurements and the
baseline Qmax measurement will be calculated. The changes in Qmax will be
compared between epithesis and prosthesis groups.
- Post-void residue (PVR) at 4 months
o The PVR will be evaluated by a trained physician or nurse using sonography.
The evaluation will be performed within 10 minutes after adequate uroflowmetry.
o At 1 and 4 months the difference between 1m and 4m PVR measurements and the
baseline PVR measurement will be calculated. The changes in PVR will be
compared between epithesis and prosthesis groups.
- Complication rate
o Complications in the epithesis group will be assessed over the study period
using the Common Terminology Criteria for Adverse Events-(CTCAE) criteria (19).
o Complications in the prosthesis group will be assessed using the
Clavien-Dindo (CD) scoring system (20).
o Both CTCAE and CD systems will be dichotomized into non-severe (CTCAE 1-2 or
CD 1-2) and severe (CTCAE 3-5 or CD 3-5) events.
o Complication rate will be compared between epithesis and prosthesis groups at
1 and 4 months.
- Cross over rate
o If a participant is not satisfied with the epithesis during the study period,
he will be free to opt for an erection prosthesis and will then cross over to
the epithesis arm.
o If a participant has had an explantation of the erection prosthesis for any
reason during the study period, he will be free to opt for an epithesis and
will then cross over to the epithesis arm.
Background summary
Gender dysphoria refers to an inner mental unrest resulting from an incongruity
between the assigned biological sex and the mentally experienced sex (1). 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
(GGAS), which 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 men, metoidioplasty or phalloplasty are performed.
In order to be able to proceed to penetrative sexual intercourse, one option
can be the implantation an internal erectile prosthesis or the use of an
external device or epithesis. Internal protheses form at this point the main
method of attaining penile rigidity after phalloplasty. Both malleable and
inflatable options are available today. However, these devices, just as the
primary GGAS procedures, carry a high risk of complications. Previous research
with prostheses originally designed for cisgender men has shown that up to 22%
of prostheses was explanted for various reasons including infection, erosion
and malfunction within 20 months (5). Another study showed that only 62% of
people still had their prosthesis in place after 4 years (6). More recent
publications with a prosthesis specifically designed for phalloplasty people
(ZSITM 475 FtM, Zephyr Surgical Implants, Switzerland, Europe) have shown
explantation rates of 19% and 23% at 9 and 18 months respectively (7,8). The
lack of reliable, and durable erectile devices leads to the fact that a large
proportion of people either chooses for phalloplasty but never goes on the
placement of an erectile prothesis or completely abandons the idea of GGAS
under the form of phalloplasty at this point in time (9). As underlined in a
recent qualitative study, transgender men may very well be concerned about the
complication rates and likely need for additional surgeries associated with the
surgical treatments they seek to diminish their gender dysphoria, specifically
in penile implant surgery (10). This is further aggravated by the fact that
penile implant surgery is associated with higher complication in a transgender
population than in a cisgender population (11). Penile prostheses were
originally designed for an older cisgender male population with treatment
resistant erectile disfunction wishing to regain the capacity of penetrative
sexual intercourse. No data exists on what the durability of penile implants
are in a younger and more sexually active population. Furthermore, the
placement of a prosthesis is particularly more difficult after phalloplasty 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 and
preventing it from erosion through the skin. Therefore, alternative options for
transgender and gender non-conforming people after phalloplasty are needed.
Although some may be surgical, it may be interesting for some individuals to
have non-surgical options as well (12).
When considering penile epitheses, multiple types are commercially available.
One of such devices is a penile lifter or splint and is marketed as the
ElatorTM or the ErektorTM for cisgender people with erectile dysfunction after
prostate cancer. These devices consist of two rigid rings connected by rigid
metal rods. The biggest of two rings is placed around the base of the phallus.
The second ring is connected to the metal rods and is placed behind the coronal
ridge. By connecting the rods to the ring at the base of the penis, tension and
therefore rigidity between the two rings is created. With the device in place,
men can then penetrate their partner and remove it again after intercourse.
Penile splints were originally designed in the beginning of the 20th century
for various reasons of erectile disfunction. Loewenstein was the first to
produce a study on his personal re-interpretation of this device in 1941 (13).
Originally, these devices have been designed for cisgender men with erectile
dysfunction, but social media and patient conversations suggest that
post-phalloplasty people have been experimenting with them. Feedback from
transgender people using this device can be found on the website of the product
manufacturers, but also on social media sites sucht as Tumblr, Youtube, and
private Facebook channels. They may form a potential alternative to internal
prostheses in transgender people not wishing to undergo further surgery after
phalloplasty or in people that have experienced problems after implantation.
Study objective
1. To generate initial data on whether a penile epithesis (ElatorTM) is a
potential alternative to a penile prosthesis (ZSITM 475 FtM) in
post-phalloplasty transgender individuals.
2. To assess participcant and partner expectations and experiences with the
usability of the penile epithesis compared to the penile prosthesis.
3. To assess participant and partner quality of life and before, during and
after penile epithesis compared to penile prosthesis use.
4. To assess participant and partner sexual and relationship satisfaction
before, during and after penile epithesis compared to penile prosthesis use.
Study design
All post-phalloplasty transgender patients in follow-up at the participating
centers who indicate a desire to pursue penetrative sexual contact will be
informed of the existence of the study. Furthermore, the study will be
announced on the Ghent University Hospital as well as the Amsterdam University
Medical Center website. The investigators will reach out to the transgender
health psychologists all over Belgium and the Netherlands to inform them of the
existence of the study, and the study recruitment information will be made
publicly available on the national transgender information website
(Transgenderinfo.be) and their social media channels. Interested participants
can contact the researchers in they are willing to participate and will be
invited for a study consultation. Recruitment will be done by all principal and
sub-investigators of the study in each of the participating centers. Central
screening for eligibility will be done by the sub-investigator of the principal
center (WiCl) who is a urologic resident experienced in transgender health. All
eligible participants will be included upon written and signed informed consent
form of both the main participant and their partner.
Upon inclusion, participants and their partners will receive an initial pre-use
assessment. Herein, a thorough history taking, and medical file evaluation will
take place (See further). Furthermore, both participant and partner will be
asked to complete an MMQ and a QSE questionnaire. They will also receive
specific questions on the device or prosthesis and sexual experience
expectations and concerns. Specific questions on previous sexual experience and
interest in penetrative sexual intercourse will be asked.
Study Cohort
After completion of the initial assessment the couples will be invited to
perform a penile measurement themselves using the company provided tools and
information first. These sizes will be recorded, and a second measurement is
performed together with the investigators using the same tools. With the
combination of these two, an actual device will be fitted. Only in case of
correct fit according to the investigators, the participant can use this device
for the rest of the study. In case of a discordant fit, further measurement
will take place using devices until the fit is deemed appropriate.
Comparison cohort
Participants will then undergo penile prosthesis implantation of the ZSITM 475
FTM prosthesis with a technique at the discretion of the performing surgeon. In
case prosthesis implantation is for any reason deemed impossible to perform,
those people will be excluded from the study. The participants are free to have
testicular prostheses placed at the same time of surgery if they wish so as
this is the general turn of events. After implantation. The participants must
refrain at least six weeks from using the prosthesis of having any sexual
intercourse using their own genitals so that the implantation site can properly
heal. After this healing period, the participants are seen in the urology
clinic. Upon discretion of the treating surgeon, the participants will be
deemed healed enough for prosthesis use and will receive practical information
on how to handle the mechanics of the prosthesis.
Participants and their partners in both groups will be asked to use the
epithesis or prosthesis over the course of one month hereafter and record usage
in an online diary for every attempt on intercourse. This diary will contain a
QSE questionnaire and open-ended questions on device experience for every
sexual encounter. During the study period, participants will be free to use a
single layer of condom during penetrative sexual intercourse as this may also
be used to prevent sexually transmitted diseases.
At the end of this first month, participants and partners will receive an MMQ
questionnaire and EDITS questionnaire to fill out. The participant only will be
asked to fill out an ICIQ-MLUTS questionnaire. The couple will also be
contacted and invited for study consultation for voiding function evaluation,
medical assessment and overall experience. If possible, tips on usage will be
provided. Then, participants and partners will be asked to continue usage for
another 3 months, during which at least 1 diary completion of both participant
and partner (of the same sexual encounter) per month is aimed for.
At the end of these additional 3 months, an overall evaluation will be made by
MMQ questionnaire, EDITS questionnaire, accompanied by specific questions on
penetrative intercourse and open-ended questions on overall sexual experience
and specific device or prosthesis experience. These measures will be taken in
both participants and their partners. The participant only will be asked to
fill out an ICIQ-MLUTS questionnaire. The couple will also be contacted and
invited for study consultation for voiding function evaluation. After the
study, the couples in the epithesis group will be free to keep using the
epithesis they received.
If a participant is not satisfied with the epithesis during the study period,
he will be free to opt for an erection prosthesis and will then cross over to
the epithesis arm. The same accounts for prosthesis arm participants. If, for
any reason, an explantation of the erection prosthesis was performed during the
study period, he will be free to opt for an epithesis and will then cross over
to the epithesis arm.
All study data will be collected and stored in REDCap for the duration of the
study and stored on a secured hospital-owned server after (24).
Intervention
The intervention group in this study will recieve a penile epithesis (penile
attachment) to enable penetration during sexual intercourse instead of an
internal erection prosthesis.
Study burden and risks
The main burden to participants receiving treatment within the context of the
study compared to those receiving the same treatment outside of it lies mainly
in the questionnaires that are required to be filled in at three different
moments. This could be considered time consuming.
Furthermore there are no additional risks or burdens associated with
participation in the study. Participants are freely able to choose which
treatment arm they would like to enter and are therefore not subject to
randomization.
Sint-Pietersnieuwstraat 25
Gent 9000
BE
Sint-Pietersnieuwstraat 25
Gent 9000
BE
Listed location countries
Age
Inclusion criteria
- Participant and partner age >= 18 years.
- Transgender or gender non-conforming individuals diagnosed according to the
DSM-5 diagnostic criteria for gender dysphoria.
- Participants 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).
- Absence of urethral stricture or other structural problem resulting in
voiding dysfunction.
- Established (primary) sexual relationship with partner who is willing to take
part in the study.
- Participant 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.
- Treatment naïve in the use of the Elatortm or Erektortm epithesis.
Exclusion criteria
- Participant age < 18 years. - 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. - Participant does not have
sufficent sensations in the phallus - No established (sexual) partner and/or
partner is not willing to take part in the study. - Participant and/or partner
have no interest in penetrative sexual intercourse.
Warnings as provided by the manufacturer, adjust and summarised according to
the needs of the target study population:
1. Always apply a water or silicone based lubricant to all areas of the phallus
in contact with the epithesis.
2. To make penetration easier at the beginning of intercourse, always prepare
with adequate foreplay.
3. Should any painful or uncomfortable physical sensations arise during
intercourse cease the activity. Apply more lubricant or change positions if
needed. If this does not alleviate the discomfort then stop use of the
epithesis immediately to prevent injury.
4. Do not use the epithesis while you or your partner are under the influence
of alcohol or drugs that may impair judgement or alter skin sensations or
awareness.
5. Do not fall asleep while wearing the epithesis, since prolonged inactivity
while wearing the epithesis may cause permanent injury to the phallus.
6. Use of the eptithesis does not prevent transmittion of sexually
transmissible diseases. Always wear a condom over the phallus and epithesis in
order to prevent this.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| Other | B6702023000188 |
| CCMO | NL84339.018.23 |