Neuropathic PainNPASRSNCT04538170
Neuropathic Pain After Orchidectomy and Sex Reassignment Surgery
An observational study of Neuropathic Pain and Phantom Pain, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Phantom Pain, Sex Reassignment Surgery
- What is being tested?
- pain after surgery
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 423 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2014to 1 Jul 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Surgery at least 6 month before data collection
- german speaking
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Tuebingen, clinic of anästhesiology and intensiv care
Tübingen, 72074
About this study
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?
Read the 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.
- Conditions
- Neuropathic Pain, Phantom Pain, Sex Reassignment Surgery
- Being tested
- pain after surgery
- Medical subject headings
- Neuralgia, Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain after surgeryBehavioural
| Study group | Role | What they receive |
|---|---|---|
| ORC | Group orchidectomy following cancer Receives: Behavioral: pain after surgery | |
| GAC | Group sex reassignment surgery Receives: Behavioral: pain after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Phantom Pain
Number of patients with phantom pain of testis
Measured: a minimum of 6 month post-surgery up to 5 years postsurgery
Secondary outcomes (2)
Functional Outcome
Number of Participants with Incontinence, Difficult Urination, Stenosis of Urethra, Spraying of Urine and/or Corrective Surgery"
Measured: 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
Measured: a minimum of 6 month post-surgery up to 5 years postsurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Sep 2014
- Primary completion8 Aug 2017
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538170
- Sponsor's protocol ID
- 611/2013BO2
- Acronym
- NPASRS
- Status last verified
- Aug 2014
- First submitted
- 9 Aug 2019
- Last updated
- 21 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropathic Pain After Orchidectomy and Sex Reassignment Surgery
- ClinicalTrials.gov ID
- NCT04538170
- Acronym / sponsor ID
- NPASRS / 611/2013BO2
- Conditions
- Neuropathic Pain, Phantom Pain, Sex Reassignment Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 4 Sep 2020 (actual)
- Results
- Posted 21 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ORC | – | Behavioral: pain after surgeryGroup orchidectomy following cancer |
| GAC | – | Behavioral: pain after surgeryGroup sex reassignment surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Surgery at least 6 month before data collection
- german speaking
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pain after surgery | Behavioural | GAC, ORC |
Primary outcome
Incidence of Phantom Pain
Time frame: a minimum of 6 month post-surgery up to 5 years postsurgery
Number of patients with phantom pain of testis
2 secondary outcomes
Functional Outcome
Time frame: a minimum of 6 month post-surgery up to 5 years postsurgery
Incidence of Chronic Postoperative Pain
Time frame: a minimum of 6 month post-surgery up to 5 years postsurgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Neuropathic Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain and Phantom Pain, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Phantom Pain (time frame: a minimum of 6 month post-surgery up to 5 years postsurgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.