Erectile Dysfunction Clinical Trial
Official title:
ZEPHYR: A Prospective Study Evaluating Surgical Outcome After Implantation of the Zephyr ZSI 475 FTM Inflatable Penile Implant in the Neophallus After Female-to-male Sex Reassignment Surgery
This study will look into the surgical outcome after implantation of the Zephyr ZSI 475 FTM in the neophallus.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2029 |
Est. primary completion date | September 2027 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations. - Age = 18 years. - Female-to-male transsexual patient. - Implantation of Zephyr ZSI 475 FTM erectile device. Exclusion Criteria: - Absence of signed written informed consent. - Age < 18 years. - Biological males. - Patients opting for penile implants other than the Zephyr ZSI 475 FTM. |
Country | Name | City | State |
---|---|---|---|
Belgium | Department of Urology, Ghent University Hospital | Ghent | Oost-Vlaanderen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Explantation-free survival | Interval between implantation date and explantation date (if explanted) | From date of surgery until the date of explantation or date of death from any cause, whichever came first, assessed up to 120 months postoperatively (assessment at 3 months postoperatively, 1 year postoperatively and then yearly) | |
Secondary | Complication rate after implantation of this device | The Clavien-Dindo system (<90d) to report surgical complications will be used | 90 days after implantation | |
Secondary | Type of complications | Complications that will be assessed, involve:
Urinary tract infection (yes or no) Hematuria (yes or no) Wound infection (yes or no) Wound dehiscence (yes or no) Abscess formation (yes or no) Fistula formation (yes or no) Protrusion of the device (yes or no) Malfunction of the device (yes or no) migration of the device (yes or no) Infection of the device (yes or no) |
From date of surgery until the date of explantation or date of death from any cause, whichever came first, assessed up to 120 months postoperatively (assessment at 3 months postoperatively, 1 year postoperatively and then yearly) |
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