PhalloplastyPHALLONCT04314141
Surgical Outcomes, Quality of Life and Patient's Satisfactions With Phalloplasty
An observational study of Phalloplasty and Surgery, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The phalloplasty is a reconstruction technique, consisting of the neophallus creation. It is performed in transgender patients in sex reassignment surgery, or in cismale patients to correct a congenital or acquired lack of penis. There are many surgical techniques, but none is optimal. Read more about this study
- Who is it for?
- Ages 20 to 73 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Phalloplasty, Surgery
- What is being tested?
- Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplasty
- Type of treatment
- Surgery or procedure
- How many people
- 143 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2020to 14 Nov 2020
- 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 20 to 73 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have undergone a phalloplasty surgery in the University Lyon Sud Hospital or Croix Rousse Hospital, between 1 January 2007 and 31 October 2018, with at least one year of back on their surgery procedures. Patients concerned with this surgery are : * transgender patients whose reassignment surgery was validated by a minimum of three members of GRETTIS, including a psychiatrist. * Patients cis males with congenital malformations, or having suffered a total or partial amputation of verge
Who may be able to join
- Major patients
- Patients who have undergone a phalloplasty surgery in the University Lyon Sud Hospital or Croix Rousse Hospital, between 1 January 2007 and 31 October 2018
- Patients with at least one year of back on their surgery procedures
- Transgender patients whose reassignment surgery was validated by a minimum of three members of GRETTIS (Groupe de Recherche, d'Etude et de Traitement des Troubles de l'Identité Sexuelle), including a psychiatrist Or Patients cis males with congenital malformations, or having suffered a total or partial amputation of verge
- Patients who do not oppose orally to participate in the study, after information
- Patients who have given their consent for the audio recording for patients taking part in semi - directive interviews
Who cannot join
- Minor patients or patients under legal protection
- Refusal to participate in the study
- No understanding of the French language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical and Functional Outcomes, Quality of Life and Patient's Satisfactions Who Have Undergone a Phalloplasty Surgery
The phalloplasty is a reconstruction technique, consisting of the neophallus creation.
It is performed in transgender patients in sex reassignment surgery, or in cismale patients to correct a congenital or acquired lack of penis.
Read more
There are many surgical techniques, but none is optimal. Surgical and functional outcomes, quality of life and patient's satisfactions with phalloplasty are missing in the international literature.
Urological center of Lyon is a reference center of this kind of surgery and has the possibility to evaluate that.
In this study, 124 transgender and 19 cismale patients with phalloplasty are eligible.
This study will allow us to adapt our practice to the patient's return and improve the information given to patients before their surgery.
It will also improve our surgical techniques, depending on the results achieved.
- Conditions
- Phalloplasty, Surgery
- Being tested
- Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplasty
- Keywords
- phalloplasty, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplastyProcedure or surgery
Send a questionnaire to patients to collect informations about:
- Sexual quality of life before and after the surgery
- Satisfaction after surgery
Data collection in medical file :
- Surgery outcomes
- Functional outcomes
| Study group | Role | What they receive |
|---|---|---|
| Transgender patients | Transgender patients who carry out sex reassignment surgery. Receives: Procedure: Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplasty | |
| Cismale patients | Cismale patients who carry out surgery to correct a congenital or acquired lack of penis. Receives: Procedure: Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Sexual quality of life of patients with phalloplasty (SEAR questionnaire) from the pre-surgery (Baseline) to one year or more after surgery
Sexual quality of life is evaluated with the SEAR (self esteem and relationship questionnaire), noted in 100.
It explores different fields of sexual life (sexual report, confidence, self esteem, general relationship with the partner).
Measured: One year or more after surgery (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start15 May 2020
- Primary completion14 Nov 2020
- Study completion14 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PhalloplastyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314141
- Sponsor's protocol ID
- 69HCL19_0759
- Acronym
- PHALLO
- Status last verified
- Aug 2025
- First submitted
- 2 Jan 2020
- Last updated
- 4 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paganelli L, Morel-Journel N, Carnicelli D, Ruffion A, Boucher F, Maucort-Boulch D, Paparel P, Terrier M, Neuville P. Determining the outcomes of urethral construction in phalloplasty. BJU Int. 2023 Mar;131(3):357-366. doi: 10.1111/bju.15915. Epub 2022 Oct 26.
PubMed 36221955Pelette R, Morel-Journel N, Carnicelli D, Ruffion A, Paganelli L, Vacheron CH, Terrier M, Madec FX, Neuville P. Functional outcomes after supra-pubic phalloplasty. J Plast Reconstr Aesthet Surg. 2024 Dec;99:263-270. doi: 10.1016/j.bjps.2024.09.065. Epub 2024 Sep 20.
PubMed 39393169
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical and Functional Outcomes, Quality of Life and Patient's Satisfactions Who Have Undergone a Phalloplasty Surgery
- ClinicalTrials.gov ID
- NCT04314141
- Acronym / sponsor ID
- PHALLO / 69HCL19_0759
- Conditions
- Phalloplasty, Surgery
- Keywords
- phalloplasty, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 14 Nov 2020 (actual)
- Study completion
- 14 Nov 2020 (actual)
- First posted
- 19 Mar 2020 (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.
The phalloplasty is a reconstruction technique, consisting of the neophallus creation.
It is performed in transgender patients in sex reassignment surgery, or in cismale patients to correct a congenital or acquired lack of penis.
There are many surgical techniques, but none is optimal. Surgical and functional outcomes, quality of life and patient's satisfactions with phalloplasty are missing in the international literature.
Urological center of Lyon is a reference center of this kind of surgery and has the possibility to evaluate that.
In this study, 124 transgender and 19 cismale patients with phalloplasty are eligible.
This study will allow us to adapt our practice to the patient's return and improve the information given to patients before their surgery.
It will also improve our surgical techniques, depending on the results achieved.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transgender patients | – | Procedure: Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplastyTransgender patients who carry out sex reassignment surgery. |
| Cismale patients | – | Procedure: Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplastyCismale patients who carry out surgery to correct a congenital or acquired lack of penis. |
Who may qualify
- Ages
- 20 to 73 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone a phalloplasty surgery in the University Lyon Sud Hospital or Croix Rousse Hospital, between 1 January 2007 and 31 October 2018, with at least one year of back on their surgery procedures. Patients concerned with this surgery are : * transgender patients whose reassignment surgery was validated by a minimum of three members of GRETTIS, including a psychiatrist. * Patients cis males with congenital malformations, or having suffered a total or partial amputation of verge
Key inclusion criteria (6 listed)
- Major patients
- Patients who have undergone a phalloplasty surgery in the University Lyon Sud Hospital or Croix Rousse Hospital, between 1 January 2007 and 31 October 2018
- Patients with at least one year of back on their surgery procedures
- Transgender patients whose reassignment surgery was validated by a minimum of three members of GRETTIS (Groupe de Recherche, d'Etude et de Traitement des Troubles de l'Identité Sexuelle), including a psychiatrist Or Patients cis males with congenital malformations, or having suffered a total or partial amputation of verge
- Patients who do not oppose orally to participate in the study, after information
Key exclusion criteria (3 listed)
- Minor patients or patients under legal protection
- Refusal to participate in the study
- No understanding of the French language
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 |
|---|---|---|
| Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplastySend a questionnaire to patients to collect informations about: * Sexual quality of life before and after the surgery * Satisfaction after surgery Data collection in medical file : * Surgery outcomes * Functional outcomes | Procedure or surgery | Cismale patients, Transgender patients |
Primary outcome
Change of Sexual quality of life of patients with phalloplasty (SEAR questionnaire) from the pre-surgery (Baseline) to one year or more after surgery
Time frame: One year or more after surgery (baseline)
Sexual quality of life is evaluated with the SEAR (self esteem and relationship questionnaire), noted in 100. It explores different fields of sexual life (sexual report, confidence, self esteem, general relationship with the partner).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 36221955Paganelli L, Morel-Journel N, Carnicelli D, Ruffion A, Boucher F, Maucort-Boulch D, Paparel P, Terrier M, Neuville P. Determining the outcomes of urethral construction in phalloplasty. BJU Int. 2023 Mar;131(3):357-366. doi: 10.1111/bju.15915. Epub 2022 Oct 26.
- Derived from this study: PubMed 39393169Pelette R, Morel-Journel N, Carnicelli D, Ruffion A, Paganelli L, Vacheron CH, Terrier M, Madec FX, Neuville P. Functional outcomes after supra-pubic phalloplasty. J Plast Reconstr Aesthet Surg. 2024 Dec;99:263-270. doi: 10.1016/j.bjps.2024.09.065. Epub 2024 Sep 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Phalloplasty and Surgery, run by Hospices Civils de Lyon at 1 site in France.
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 3 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: finished, as of the sponsor's last update on 4 Sep 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Sexual quality of life of patients with phalloplasty (SEAR questionnaire) from the pre-surgery (Baseline) to one year or more after surgery (time frame: One year or more after surgery (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04314141, which also lists 2 linked publications.
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 4 Sep 2025.