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NCT03149692

Penile Transplant Study

Completed NA Last updated 6 October 2021
What this trial tests

NA trial testing Penile allograft transplantation in Penile Amputation in 2 participants. Completed in 11 December 2020.

Timeline
11 November 2011
Primary endpoint
11 December 2019
11 December 2020

Quick facts

Lead sponsorUniversity of Stellenbosch
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment2
Start date11 November 2011
Primary completion11 December 2019
Estimated completion11 December 2020
Sites1 location across South Africa

Drugs / interventions tested

Conditions studied

Sponsor

University of Stellenbosch

Who can join

Adults 18 to 40, male only, with Penile Amputation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

One case of unsuccessful penile transplantation has been reported from China. The patient had suffered an industrial machine accident and lost his penis to the level of the pubic skin. Unfortunately the patient's wife insisted at about two weeks post-operatively that the organ be removed. At the time of surgical removal the penis was viable, except for a degree of superficial skin necrolysis. This has sparked debate on ethical issues regarding penile transplantation. South Africa is uniquely positioned in Sub-Saharan Africa and worldwide with relatively advanced medical services and a high prevalence of ritual circumcision practice with reports of high morbidity and mortality in the last 20 years. The substantial number of young men left with a severe penile defect or complete loss of the penis \[9\] creates a possible place for penile allograft transplantation as a treatment option.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Living with someone else's penis: The lived experiences of two South African penile allograft recipients: A descriptive phenomenological study.
    van der Merwe A, Toefy Y, Moosa MR, van Deventer H, et al · · 2021 · cited 7× · PMID 34527236 · DOI 10.1016/j.amsu.2021.102794

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