TransgenderismAIDNCT06639763
Erectile Aid Use in Post-phalloplasty and Post-metoidioplasty Transgender Patients
An observational study of Transgenderism and Erectile Dysfunction, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This study seeks to explore the various methods used by transgender men for sexual intercourse following phalloplasty or metoidioplasty, focusing on their satisfaction with different erectile aids, as well as the satisfaction of their partners. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Transgenderism, Erectile Dysfunction, Gender Dysphoria
- What is being tested?
- Questionnaire
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Jul 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Transgender male individuals having undergone masculinizing genital gender affirming surgery at least six months ago and who are currently sexually active and are seeking sexual penetration are eligible.
Who may be able to join
- Patient and partner age ≥ 18 years.
- Transgender or gender non-conforming individuals (and their partners).
- Patients have undergone phalloplasty or metoidioplasty as a form of genital gender affirming surgery.
- ≥6 months after phalloplasty or metoidioplasty (any type of flap or technique is allowed).
- Sexually active or has been sexually active since phalloplasty or metoidioplasty with a partner or main sexual partner.
- Voluntarily agreed that the data may be used for an anonymized scientific study.
Who cannot join
- Patient age \< 18 years.
- Cisgender patients treated with phalloplasty or metoidioplasty for various reasons.
- \<6 months after phalloplasty or metoidioplasty.
- Not sexually active since phalloplasty/metoidioplasty.
- Patient and/or partner have no interest in penetrative sexual intercourse.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Department of Urology, University Hospital Ghent
Ghent, East-Flanders, 9000
Wietse Claeys, MD, 003293322276, wietse.claeys@ugent.be
Anne-Françoise Spinoit, MD, PhD, 003293322276, anne-francoise.spinoit@uzgent.be
About this study
Official title: Erectile Aid Use in Post-phalloplasty and Post-metoidioplasty Transgender Patients: an Epidemiological Survey
This study seeks to explore the various methods used by transgender men for sexual intercourse following phalloplasty or metoidioplasty, focusing on their satisfaction with different erectile aids, as well as the satisfaction of their partners. Phalloplasty and metoidioplasty are gender-affirming surgeries that often require additional aids to achieve the desired sexual function, particularly for penetration. While internal erectile prostheses are common after phalloplasty, they come with high complication rates, leading some patients to opt for non-surgical aids. However, the effectiveness and comfort of these aids are not well-documented. This study aims to fill this gap by examining the types of aids transgender men use, how well these aids meet their sexual needs, and how satisfied both they and their partners are with the outcomes, providing much-needed insight for healthcare providers and patients alike.
Read the detailed description
Gender dysphoria (GD) is defined as a \"marked incongruence between an individuals' experienced or expressed gender and the one they were assigned to at birth\". This definition is in accordance with the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Many GD individuals seek medical aid in the form of psychological counseling, hormonal treatment, and, if desired, surgery to align their physical appearance with the perceived gender identity. 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 phalloplasty, anatomically sized external genitalia (penis with or without urethra, scrotum, and perineum) are created using on the one hand a donor skin flap (usually from the forearm, upper leg or inguinal region), and on the other hand tissues from the original genitals. In metoidioplasty, the goal is to create anatomically looking but undersized external genitalia in which the clitoris forms the base of a micro-penis. One study in the United States reported that about 3% of transgender men have undergone a phalloplasty and 19% would like to undergo the procedure in the future. For a metoidioplasty, the numbers are 2% and 25%, respectively. One of the reasons for undergoing masculinizing GGAS is to gain the ability to penetrate a partner during intercourse. As there is no erectile tissue present in the neophallus after phalloplasty, penetration is usually not possible without the use of external or internal erectile aids. In metoidioplasty, the phallus does possess erectile tissue but the eventual size of this microphallus is largely dependent on the individually obtained clitoral hypertrophy after hormonal therapy and the body constitution. Therefore, the ability to penetrate a sexual partner after metoidioplasty cannot be assured.
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. These form the main method of attaining penile rigidity after phalloplasty to date. While a multitude of both malleable and inflatable devices are available, these procedures, just as primary GGAS, carry a high risk of complication. 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. Another study showed that only 62% of patients still had their prosthesis in place after 4 years. More recent publications with a prosthesis specifically designed for phalloplasty patients (ZSI TM 475 FtM, Zephyr Surgical Implants, Switzerland, Europe) have shown explantation rates of 19% and 23% at 9 and 18 months respectively. The lack of reliable, and durable erectile devices leads to the fact that a large proportion of patients 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. 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. In addition to internal devices, external ways of obtaining phallic rigidity have been put forward. The use of one or multiple tight condoms with or without the use of self-adhesive bandages tapering the phallus has been reported, as well as the use of penile sleeves readily available on the market or made to measure. Finally, the use of penile lifters or splints has been evaluated in post-phalloplasty individuals with varying results. However, it is unclear which of these erectile aids are most commonly used and, evenly important, how satisfied patients and their partners are with them.
In metoidioplasty, the neophallus does contain cavernosal bodies. However, according to a study in Belgrade in which 813 metoidioplasties were performed, penetration is not possible due to the small size of the neophallus for those who reported sexual intercourse. Other studies report patients who were able to penetrate after metoidioplasty. According to a review by Frey et al. 51% were able to penetrate. Cohanzad et al. reported a technique, extensive metoidioplasty which they performed on 10 people after which 70% were able to obtain an erection rigid enough for penetration. In another study, they used a penile traction device in 10 transgender and 4 cisgender men to increase the length of the phallus after extensive metoidioplasty. The result was a mean penile length increase of 28.42 mm (21-47 ± 6.86). 9 of 11 participants were eventually able to penetrate during sexual intercourse (1 child and 2 virgin singles who had never had sexual contact were excluded). However, it is not stated whether the participants were already capable of penetration before they started using the device. As in cisgender men with erectile dysfunction, some individuals have reported the use of phospho-diesterase 5 inhibitors (PDE5i's) such as Sildenafil or Tadalafil to increase their natural erection. These PDE5i's increase the inflow of blood into the phallus by relaxing the smooth muscle cells in the cavernosal tissue. Another option is intracavernosal injections (ICI's) with Alprostadil. However, knowledge about these two options in post-metoidioplasty individuals is limited. A study by Khorrami et al. examined sexual aspects that are deemed important to those who underwent metoidioplasty. They found that being able to get and maintain an erection was very important in up to 93% of studied individuals, but only 40% valued the ability to have penetrative intercourse equally. An explanation would be because patients do not expect to get a phallus large enough for penetration after metoidioplasty. Thus, the reason they use PDE5i or ICI to improve erection is not only to penetrate the partner, but also because a better erection allegedly also makes for a better orgasm. Another study by Neuville et al. describes the possibility of a semi-rigid prosthesis for metoidioplasty. This technique seems to be successful in terms of post-operative satisfaction, regrets about the surgery and urinary position. However, it is not examined whether penetration during sexual activity with this semi-rigid prosthesis has improved. Other erectile aids used in metoidioplasty apart from PDE5i and ICI are rarely studied.
Apart from the study of Boskey et al., the success and satisfaction rates of these non- surgical erectile aids are unknown or limited to anecdotal reports of individual patients. The erectile aid examined in this study is the Elator. This device seems to be a good option for penetrative sex in trans men who do not (yet) want an internal prosthesis. However, the results showed that only a few couples were able to use the device effectively to have intercourse in the way they envisioned beforehand. For the majority of the studied population, the Elator proved uncomfortable during use, or did not appear to have the right fit since the device was originally designed for cis-men and the phallus of transmen has a different anatomy. A limitation of this study, however, is the small study population.
Given that no prescription or medical intervention is required to obtain these non-surgical aids, only a small portion of the population that does not opt for an internal prosthesis is still on the physician\'s radar. The limited knowledge on erectile aids in scientific literature makes it difficult for health care providers to offer supported advice to post-surgical transgender individuals in search of alternatives to surgically implanted erection prostheses.
The purpose of this study is to investigate what methods are used for sexual intercourse by transgender men who have undergone phalloplasty or metoidioplasty and how satisfied they and their partners are with these erectile aids. All patients who are sexually active and at least 6 months after primary genital gender-affirming surgery are eligible.
- Being tested
- Questionnaire
- Keywords
- Gender dysphoria, Transgender, Phalloplasty, Metoidioplasty, Erectile dysfunction, Sexual function, Genital reconstruction, Reconstructive urology, Erectile aid, Patient Reported Outcome Measures (PROMs), Erection prosthesis, Penile epithesis
- Medical subject headings
- Transsexualism, Erectile Dysfunction, Gender Dysphoria, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireDiagnostic test
Questionnaire containing a combination of basic epidemiological questions, questions regarding recent sexual activity, questions regarding sexual preference and sexual activity, questions regarding the use of different types of erectile aids, questions regarding satisfaction with the use of these different erectile aid and questions regarding the satisfaction with sexual functioning and the partner relation. Al patients at least 6 months after primary genital gender-affirming surgery and who are sexually active are eligible.
What is being measured
The primary outcome is the main question the study is designed to answer.
Types of erectile aids used
A series of closed and open-ended questions are asked meant to uncover what erectile aids are used by post-phalloplasty and post-metoidioplasty individuals and their partners.
Measured: One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplasty
Treatment satisfaction
Assessed using Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire (EDITS).
The EDITS questionnaire 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.
Measured: One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplasty
Secondary outcomes (2)
Epidemiology
Baseline questions regarding speaking language, gender and current anatomy
Measured: One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplasty
Quality of sexual experience
Assessed using Quality of Sexual Experience questionnaire (QSE). The QSE questionnaire provides a summative score between 7 and 49. A higher score indicates a better sexual experience.
Measured: One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start6 Jul 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderismStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Françoise Spinoit, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639763
- Sponsor's protocol ID
- ONZ-2023-0606
- Acronym
- AID
- Status last verified
- Oct 2024
- First submitted
- 19 Aug 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erectile Aid Use in Post-phalloplasty and Post-metoidioplasty Transgender Patients: an Epidemiological Survey
- ClinicalTrials.gov ID
- NCT06639763
- Acronym / sponsor ID
- AID / ONZ-2023-0606
- Keywords
- Gender dysphoria, Transgender, Phalloplasty, Metoidioplasty, Erectile dysfunction, Sexual function, Genital reconstruction, Reconstructive urology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 6 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to explore the various methods used by transgender men for sexual intercourse following phalloplasty or metoidioplasty, focusing on their satisfaction with different erectile aids, as well as the satisfaction of their partners. Phalloplasty and metoidioplasty are gender-affirming surgeries that often require additional aids to achieve the desired sexual function, particularly for penetration. While internal erectile prostheses are common after phalloplasty, they come with high complication rates, leading some patients to opt for non-surgical aids. However, the effectiveness and comfort of these aids are not well-documented. This study aims to fill this gap by examining the types of aids transgender men use, how well these aids meet their sexual needs, and how satisfied both they and their partners are with the outcomes, providing much-needed insight for healthcare providers and patients alike.
Detailed description
Gender dysphoria (GD) is defined as a \"marked incongruence between an individuals' experienced or expressed gender and the one they were assigned to at birth\". This definition is in accordance with the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Many GD individuals seek medical aid in the form of psychological counseling, hormonal treatment, and, if desired, surgery to align their physical appearance with the perceived gender identity. 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 phalloplasty, anatomically sized external genitalia (penis with or without urethra, scrotum, and perineum) are created using on the one hand a donor skin flap (usually from the forearm, upper leg or inguinal region), and on the other hand tissues from the original genitals. In metoidioplasty, the goal is to create anatomically looking but undersized external genitalia in which the clitoris forms the base of a micro-penis. One study in the United States reported that about 3% of transgender men have undergone a phalloplasty and 19% would like to undergo the procedure in the future. For a metoidioplasty, the numbers are 2% and 25%, respectively. One of the reasons for undergoing masculinizing GGAS is to gain the ability to penetrate a partner during intercourse. As there is no erectile tissue present in the neophallus after phalloplasty, penetration is usually not possible without the use of external or internal erectile aids. In metoidioplasty, the phallus does possess erectile tissue but the eventual size of this microphallus is largely dependent on the individually obtained clitoral hypertrophy after hormonal therapy and the body constitution. Therefore, the ability to penetrate a sexual partner after metoidioplasty cannot be assured.
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. These form the main method of attaining penile rigidity after phalloplasty to date. While a multitude of both malleable and inflatable devices are available, these procedures, just as primary GGAS, carry a high risk of complication. 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. Another study showed that only 62% of patients still had their prosthesis in place after 4 years. More recent publications with a prosthesis specifically designed for phalloplasty patients (ZSI TM 475 FtM, Zephyr Surgical Implants, Switzerland, Europe) have shown explantation rates of 19% and 23% at 9 and 18 months respectively. The lack of reliable, and durable erectile devices leads to the fact that a large proportion of patients 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. 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. In addition to internal devices, external ways of obtaining phallic rigidity have been put forward. The use of one or multiple tight condoms with or without the use of self-adhesive bandages tapering the phallus has been reported, as well as the use of penile sleeves readily available on the market or made to measure. Finally, the use of penile lifters or splints has been evaluated in post-phalloplasty individuals with varying results. However, it is unclear which of these erectile aids are most commonly used and, evenly important, how satisfied patients and their partners are with them.
In metoidioplasty, the neophallus does contain cavernosal bodies. However, according to a study in Belgrade in which 813 metoidioplasties were performed, penetration is not possible due to the small size of the neophallus for those who reported sexual intercourse. Other studies report patients who were able to penetrate after metoidioplasty. According to a review by Frey et al. 51% were able to penetrate. Cohanzad et al. reported a technique, extensive metoidioplasty which they performed on 10 people after which 70% were able to obtain an erection rigid enough for penetration. In another study, they used a penile traction device in 10 transgender and 4 cisgender men to increase the length of the phallus after extensive metoidioplasty. The result was a mean penile length increase of 28.42 mm (21-47 ± 6.86). 9 of 11 participants were eventually able to penetrate during sexual intercourse (1 child and 2 virgin singles who had never had sexual contact were excluded). However, it is not stated whether the participants were already capable of penetration before they started using the device. As in cisgender men with erectile dysfunction, some individuals have reported the use of phospho-diesterase 5 inhibitors (PDE5i's) such as Sildenafil or Tadalafil to increase their natural erection. These PDE5i's increase the inflow of blood into the phallus by relaxing the smooth muscle cells in the cavernosal tissue. Another option is intracavernosal injections (ICI's) with Alprostadil. However, knowledge about these two options in post-metoidioplasty individuals is limited. A study by Khorrami et al. examined sexual aspects that are deemed important to those who underwent metoidioplasty. They found that being able to get and maintain an erection was very important in up to 93% of studied individuals, but only 40% valued the ability to have penetrative intercourse equally. An explanation would be because patients do not expect to get a phallus large enough for penetration after metoidioplasty. Thus, the reason they use PDE5i or ICI to improve erection is not only to penetrate the partner, but also because a better erection allegedly also makes for a better orgasm. Another study by Neuville et al. describes the possibility of a semi-rigid prosthesis for metoidioplasty. This technique seems to be successful in terms of post-operative satisfaction, regrets about the surgery and urinary position. However, it is not examined whether penetration during sexual activity with this semi-rigid prosthesis has improved. Other erectile aids used in metoidioplasty apart from PDE5i and ICI are rarely studied.
Apart from the study of Boskey et al., the success and satisfaction rates of these non- surgical erectile aids are unknown or limited to anecdotal reports of individual patients. The erectile aid examined in this study is the Elator. This device seems to be a good option for penetrative sex in trans men who do not (yet) want an internal prosthesis. However, the results showed that only a few couples were able to use the device effectively to have intercourse in the way they envisioned beforehand. For the majority of the studied population, the Elator proved uncomfortable during use, or did not appear to have the right fit since the device was originally designed for cis-men and the phallus of transmen has a different anatomy. A limitation of this study, however, is the small study population.
Given that no prescription or medical intervention is required to obtain these non-surgical aids, only a small portion of the population that does not opt for an internal prosthesis is still on the physician\'s radar. The limited knowledge on erectile aids in scientific literature makes it difficult for health care providers to offer supported advice to post-surgical transgender individuals in search of alternatives to surgically implanted erection prostheses.
The purpose of this study is to investigate what methods are used for sexual intercourse by transgender men who have undergone phalloplasty or metoidioplasty and how satisfied they and their partners are with these erectile aids. All patients who are sexually active and at least 6 months after primary genital gender-affirming surgery are eligible.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Transgender male individuals having undergone masculinizing genital gender affirming surgery at least six months ago and who are currently sexually active and are seeking sexual penetration are eligible.
Key inclusion criteria (6 listed)
- Patient and partner age ≥ 18 years.
- Transgender or gender non-conforming individuals (and their partners).
- Patients have undergone phalloplasty or metoidioplasty as a form of genital gender affirming surgery.
- ≥6 months after phalloplasty or metoidioplasty (any type of flap or technique is allowed).
- Sexually active or has been sexually active since phalloplasty or metoidioplasty with a partner or main sexual partner.
Key exclusion criteria (5 listed)
- Patient age \< 18 years.
- Cisgender patients treated with phalloplasty or metoidioplasty for various reasons.
- \<6 months after phalloplasty or metoidioplasty.
- Not sexually active since phalloplasty/metoidioplasty.
- Patient and/or partner have no interest in penetrative sexual intercourse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire containing a combination of basic epidemiological questions, questions regarding recent sexual activity, questions regarding sexual preference and sexual activity, questions regarding the use of different types of erectile aids, questions regarding satisfaction with the use of these different erectile aid and questions regarding the satisfaction with sexual functioning and the partner relation. Al patients at least 6 months after primary genital gender-affirming surgery and who are sexually active are eligible. | Diagnostic test | – |
Primary outcome
Types of erectile aids used
Time frame: One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplasty
A series of closed and open-ended questions are asked meant to uncover what erectile aids are used by post-phalloplasty and post-metoidioplasty individuals and their partners.
Treatment satisfaction
Time frame: One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplasty
Assessed using Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire (EDITS). The EDITS questionnaire 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.
2 secondary outcomes
Epidemiology
Time frame: One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplasty
Quality of sexual experience
Time frame: One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplasty
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Françoise Spinoit, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgenderism and Erectile Dysfunction, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wietse Claeys, MD (003293322276, wietse.claeys@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Types of erectile aids used (time frame: One time questionnaire at least six months after primary genital gender affirming phalloplasty or metoidioplasty). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.