Surgical Outcomes, Quality of Life and Patient's Satisfactions With Phalloplasty

Study Overview
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Brief Summary
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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.

Official Title
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Surgical and Functional Outcomes, Quality of Life and Patient's Satisfactions Who Have Undergone a Phalloplasty Surgery

Conditions
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Phalloplasty, Surgery

Intervention / Treatment
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* Procedure: Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 73 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transgender patients<br>Transgender patients who carry out sex reassignment surgery. | Procedure: Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplasty<br>* 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<br>|
| Cismale patients<br>Cismale patients who carry out surgery to correct a congenital or acquired lack of penis. | Procedure: Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplasty<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | One year or more after surgery (baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phalloplasty, surgery