Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia
NCT ID: NCT03876977
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
1 participants
INTERVENTIONAL
2020-08-08
2021-09-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Show the pain improvement 3-month after robotic laparoscopic pudendal nerve decompression for pudendal neuralgia.
Primary outcomes:
Pain evaluated on a VAS before surgery and 3-month after surgery or surveillance Improvement is considered if pain decreased by at least 3/10 points on the VAS.
Secondary purposes:
* improvement of quality of life
* study of MRI performance to predict pudendal nerve entrapment topography
* show the feasibility and safety of robotic pudendal nerve decompression
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Non-invasive
Neuropathic drugs Pudendal infiltration
No interventions assigned to this group
Robotic laparoscopic decompression
Robotic laparoscopic decompression of pudendal nerve entrapment.
Robotic laparoscopic decompression of pudendal nerve entrapment
Robotic laparoscopic decompression of pudendal nerve entrapment.
Transperitoneal Laparoscopic Robotic assistance
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Robotic laparoscopic decompression of pudendal nerve entrapment
Robotic laparoscopic decompression of pudendal nerve entrapment.
Transperitoneal Laparoscopic Robotic assistance
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Pudendal neuralgia according to Nantes criteria
* pudendal nerve entrapment reachable with robotic transperitoneal approach
Exclusion Criteria
* history of pain ≥ 18 months
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Strasbourg, France
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Service d'urologie
Strasbourg, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
7253
Identifier Type: -
Identifier Source: org_study_id