Surgical Outcomes, Quality of Life and Patient's Satisfactions With Phalloplasty (NCT04314141) | Clinical Trial Compass
CompletedNot Applicable
Surgical Outcomes, Quality of Life and Patient's Satisfactions With Phalloplasty
France143 participantsStarted 2020-05-15
Plain-language 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. 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.
Who can participate
Age range
20 Years – 73 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Minor patients or patients under legal protection
* Refusal to participate in the study
* No understanding of the French language
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of Sexual quality of life of patients with phalloplasty (SEAR questionnaire) from the pre-surgery (Baseline) to one year or more after surgery
Timeframe: One year or more after surgery (baseline)