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

NCT04314141 | Completed

• 1 other identifier: 69HCL19_0759
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Phalloplasty; Surgery

Keywords

phalloplasty; surgery

Outcome Measures

Primary Outcomes (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

  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)

Study Arms (2)

Transgender patients

Transgender patients who carry out sex reassignment surgery.

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

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

Interventions

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

Cismale patients; Transgender patients

Eligibility Criteria

• Age: 20 Years - 73 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Urology Department, Hospices Civis de Lyon

Pierre-Bénite, France

Location

Related Publications (2)

• Paganelli L, Morel-Journel N, Carnicelli D, Ruffion A, Boucher F, Maucort-Boulch D, Paparel P, Terrier M, Neuville P. Determining the outcomes of urethral construction in phalloplasty. BJU Int. 2023 Mar;131(3):357-366. doi: 10.1111/bju.15915. Epub 2022 Oct 26.

  PMID: 36221955 BACKGROUND

• Pelette R, Morel-Journel N, Carnicelli D, Ruffion A, Paganelli L, Vacheron CH, Terrier M, Madec FX, Neuville P. Functional outcomes after supra-pubic phalloplasty. J Plast Reconstr Aesthet Surg. 2024 Dec;99:263-270. doi: 10.1016/j.bjps.2024.09.065. Epub 2024 Sep 20.

  PMID: 39393169 DERIVED

MeSH Terms

Interventions

Quality of Life; Phalloplasty

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: March 19, 2020
• Study Start: May 15, 2020
• Primary Completion: November 14, 2020
• Study Completion: November 14, 2020
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

FR (1)