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

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.

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Key information

Conditions

Phalloplasty Surgery

Age range

20 year–73 year

Sex eligibility

Male

Study type

Observational

Primary location

Urology Department, Hospices Civis de Lyon

Pierre-Bénite, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplasty

Procedure

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

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PHALLO

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Mar 19, 2020
Registry last updated: Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Enrolling by Invitation