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

Completed

• Conditions: Phalloplasty; Surgery
• Interventions: Procedure: Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplasty

• Registration Number: NCT04314141
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-02
• Study First Submitted QC: 2020-03-18
• Study First Posted: 2020-03-19
• Study Start: 2020-05-15
• Primary Completion: 2020-11-14
• Study Completion: 2020-11-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 143

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

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Exclusion Criteria

• Minor patients or patients under legal protection
• Refusal to participate in the study
• No understanding of the French language

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cismale patients	Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplasty	Cismale patients who carry out surgery to correct a congenital or acquired lack of penis.
Transgender patients	Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplasty	Transgender patients who carry out sex reassignment surgery.

Primary Outcome Measures

Name	Time	Method
Change of Sexual quality of life of patients with phalloplasty (SEAR questionnaire) from the pre-surgery (Baseline) to one year or more after surgery	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).

Trial Locations

Locations (1)

Urology Department, Hospices Civis de Lyon; 🇫🇷 Pierre-Bénite, France