Neuropathic Pain After Orchidectomy and Sex Reassignment Surgery (NPASRS)

Phantom pain is associated with cortical reorganization after amputation. This phenomenon should not play a role in transsexual women, since the cortical representation of the male sex organs is presumably altered. The study investigates the incidence of phantom pain in this patient population.

For this study the following question should be investigated:

Is the incidence of phantom pain and local chronic postsurgical pain lower in sex reassignment surgery from male to female compared to inguinal tumor orchidectomy?

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain; Phantom Pain; Sex Reassignment Surgery
• Intervention / Treatment: Behavioral: pain after surgery

Detailed Description

Phantom pain is a common and much studied phenomenon after amputation.The loss of visceral organs is also associated with phantom pain. Under entirely different conditions than the removal of a tumorous testicle, sex reassignment surgery from male to female sex occurs in transsexual women. In this operation, parts of the penis and both testicles are removed and a plastic surgical transformation is made into a female genital.The surgical trauma is greater compared to an orchidectomy.

The sex reassignment surgery is expressly desired, the amputated tissues are rejected or perceived as not belonging to the patient's own body and thus do not appear as a loss. The group of patients with tumor orchidectomy acts as a control group.

In addition to the incidence of phantom pain and chronic local postoperative pain in comparison between the two groups, the secondary objectives of the study were defined as the occurrence of phantom pain, the type of pain and the intensity of pain.

Two patient groups were compared, the group after sex reassignment surgery (GAC) and the group after inguinal orchidectomy for testicular tumor (ORC).

A total of 265 transgender women were written to, 46 of whom had undergone surgery in Tübingen and 219 in Munich. The operations took place between 2002 and 2014.

For the group of patients after orchidectomy, 158 men who had undergone surgery in Tuebingen between 2010 and 2014 were contacted by letter.

The pseudonymization was done with a combination of letters and numbers, which were created with a key generator program.

The patients received a questionnaire divided into several categories, these categories were questions on demography, pre- and postoperative pain as well as phantom pain, pain processing, quality of life, sex life and urological questions.

• Study Type: Observational
• Enrollment (Actual): 423

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany, 72074
    • University Tuebingen, clinic of anästhesiology and intensiv care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients after surgery (orcidectomy and sex resignment surgery in the universtiy hospital of Tuebingen Department of Urology and the Hospital of Munich Bogenhausen Department of Urology

Description

Inclusion Criteria:

• Surgery at least 6 month before data collection
• german speaking

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ORC; Group orchidectomy following cancer	Behavioral: pain after surgery
GAC; Group sex reassignment surgery	Behavioral: pain after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Phantom Pain	Number of patients with phantom pain of testis	a minimum of 6 month post-surgery up to 5 years postsurgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Outcome	Number of Participants with Incontinence, Difficult Urination, Stenosis of Urethra, Spraying of Urine and/or Corrective Surgery"	a minimum of 6 month post-surgery up to 5 years postsurgery
Incidence of Chronic Postoperative Pain	Number of patients with chronic pain after surgery and differences between the two groups	a minimum of 6 month post-surgery up to 5 years postsurgery

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): August 8, 2017
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Perceptual Disorders; Pain, Postoperative; Neuralgia; Phantom Limb
• Other Study ID Numbers: 611/2013BO2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No