Neuropathic Pain After Orchidectomy and Sex Reassignment Surgery
Conditions: Neuropathic Pain, Phantom Pain, Sex Reassignment Surgery
Sponsor: University Hospital Tuebingen

 
 
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Neuropathic Pain After Orchidectomy and Sex Reassignment Surgery (NPASRS) 
 
 
 
 
 
ClinicalTrials.gov ID NCT 04538170  
 
Date of Initial Ethical Release: 23.10.2013 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Correspondence:  
Barbara.Schlisio@med.uni-tuebingen.de 
Department of Anaesthesiology and Intensive Care Medicine, Eberhard-Karls-
University,Tuebingen, Germany   
 

 
 
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Background:  
Phantom pain may occur after surgical removal of male reproductive organs. The indication 
for the surgery determines the physical and psychological predisposition of the patient that 
may differ between men who receive a tumor orchidectomy and those receiving gender 
reassignment surgery. 
 
Objective:  
To determine whether patients experience phantom pain after gender reassignment surgery. 
 
Study protocol: 
Transgender women who had undergone gender reassignment surgery in the Urology Clinic 
of the University of Tübingen and in the Surgical Clinic Munich-Bogenhausen should be 
retrospectively surveyed using written questionnaires. There should be at least 6 months 
between the survey and the surgical intervention for gender reassignment. Participation in the 
survey is pseudonymized and voluntary.  
The control group includes men who had to undergo an orchiectomy for oncological 
indications. Here, too, there should be at least 6 months between the operation and the survey 
in order to record chronic pain and not postoperative pain.  
 
Study population:  
The cohort size of the study is limited in that the gender reassignment surgery is a very rare 
procedure. We aim to include around 40 women in this group, with an estimated response rate 
of 80% for the questionnaires, so we want to write to at least 50 women. The control group 
(patients after oncological indicated orchiectomy) should include 145 men based on biometric 
considerations - with an estimated response rate of 60% in this group, we would write to 242 
patients. For a difference of 20% considered relevant for the occurrence of phantom pain 
(approx. 25% share after oncological indicated orchidectomy, 5% after gender reassignment), 
a significance level of 5% with a power of 80% could be achieved.  
Contact is made via the operating urological departments of the University Clinic Tübingen and 
the Surgical Clinic Munich-Bogenhausen. For this purpose, the patients are informed about 
the study (participant information). The questionnaire is pseudonymized and sent by post. 
Patients are asked to give their consent to the evaluation and publication of the research 
results in scientific journals. After receipt of the signed declaration of consent, the questionnaire 
will be scientifically evaluated.  
Inclusion and exclusion criteria: Participation in this study is voluntary. You must be of legal 
age. The women and men should be able to give their consent and be able to fill out the form 
independently and without outside help.  
 
Test procedure:  
 
Basic questionnaire to collect demographic data such as age, gender 
Pain detect questionnaire for the detection of neuropathic pain 
Record of phantom feelings and phantom pain through dichotomous questions 
Ability to cope with pain recorded by the FESV questionnaire  
Numerical rating scale (NRS) for recording the intensity of pain 
Health-related quality of life SF 12 
Sexual satisfaction through dichotomous questions 
Incidence of surgical complications from dichotomous issues