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

August 27, 2025 updated by: Hospices Civils de Lyon

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Bénite, France
        • Urology Department, Hospices Civis de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transgender patients
Transgender patients who carry out sex reassignment surgery.
Procedure: Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplasty

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
Cismale patients
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

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

What is the study measuring?

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
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).
One year or more after surgery (baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2020

Primary Completion (Actual)

November 14, 2020

Study Completion (Actual)

November 14, 2020

Study Registration Dates

First Submitted

January 2, 2020

First Submitted That Met QC Criteria

March 18, 2020

First Posted (Actual)

March 19, 2020

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL19_0759

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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