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Penile Transplant Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03149692
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Andre van der Merwe, University of Stellenbosch

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Penile Amputation Other: Penile allograft transplantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Proof of concept
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Penile Allograft Transplantation for Men With Penile Loss After Ritual Circumcision
Actual Study Start Date : November 11, 2011
Estimated Primary Completion Date : December 11, 2020
Estimated Study Completion Date : December 11, 2021

Arm Intervention/treatment
Experimental: Penile allograft Other: Penile allograft transplantation
Proof of concept of surgical procedure




Primary Outcome Measures :
  1. Urinary function [ Time Frame: 3 months after surgery ]
    Normal standing urination (subjects/patients had to sit to urinate before)

  2. Sexual function [ Time Frame: 3 months ]
    Normal sexual intercourse as for the subject - with or without medication assistance measured with IIEF score

  3. Quality of life score [ Time Frame: 6 months post operative ]
    Improved (or not) measured QoL with SF 36 software



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must be males with loss of penis after ritual circumcision
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male patients 18 years or older with total or partial penile loss as a complication from ritual circumcision, who are willing and able to provide written, informed consent.

Exclusion Criteria:

  • Immunosuppression (HIV positive, diabetes mellitus or drugs affecting immune response) Active tuberculosis (TB) or a history of TB Previous forearm free flap Disorders of circulation (e.g. peripheral vascular disease, vasculitis) History of prior malignancy Renal failure and not on a renal replacement programme Systemic disease deemed by the investigator serious enough to preclude the use of immunosuppression agents Mental illness Patients who are unwilling, unable or unlikely to comply with immunosuppressive treatment and regular follow-up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149692


Contacts
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Contact: Andre Van der Merwe, MD +27219389282 arvdm@sun.ac.za
Contact: Ray Adams +27219389090 radams@sun.ac.za

Locations
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South Africa
Stellenbosch University - Faculty of Medicine and Health Sciences, Division Urology Recruiting
Cape Town, Western Cape, South Africa, 7505
Contact: Andre Van der Merwe, MD    +27219389094    arvdm@sun.ac.za   
Contact: Ray Adams    +27219389094    radams@sun.ac.za   
Sub-Investigator: Amir Zarrabi, MD         
Sub-Investigator: Alexander Zulhke, MD         
Principal Investigator: Andre Van der Merwe, MD         
Sub-Investigator: Nicola Barsdorf, PhD         
Sub-Investigator: Rafique Moosa, PhD         
Sub-Investigator: Pieter Spies, MD         
Sub-Investigator: Bertha Bailey, RN         
Sub-Investigator: Hilgard Ackermann, MD         
Sub-Investigator: Talal Al-Quoud, MD         
Sub-Investigator: Frank Graewe, MD         
Sub-Investigator: Dedan Opondo, MD         
Sub-Investigator: Johan Nel, MD         
Sponsors and Collaborators
University of Stellenbosch
Investigators
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Study Director: Rafique Moosa, PhD University Stellenbosch

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Responsible Party: Andre van der Merwe, Associate Professor, University of Stellenbosch
ClinicalTrials.gov Identifier: NCT03149692    
Other Study ID Numbers: N11/07/243
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Via publication or request. Low subject numbers expected

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No