Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia
- Conditions
- Robotic Decompression
- Interventions
- Procedure: Robotic laparoscopic decompression of pudendal nerve entrapment
- Registration Number
- NCT03876977
- Lead Sponsor
- University Hospital, Strasbourg, France
- Brief Summary
Primary purpose:
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
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- Age 18 - 70 years old
- Pudendal neuralgia according to Nantes criteria
- pudendal nerve entrapment reachable with robotic transperitoneal approach
- bilateral pain
- history of pain ≥ 18 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Robotic laparoscopic decompression Robotic laparoscopic decompression of pudendal nerve entrapment Robotic laparoscopic decompression of pudendal nerve entrapment.
- Primary Outcome Measures
Name Time Method Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points. (0 no pain -10 extreme pain ) 3-months after surgery or surveillance Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points.
Daily collection by the patient over 1 week in real life conditions. Achievement of an average of the scores over 1 week.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Service d'urologie
🇫🇷Strasbourg, France