Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia (ERIS)
Primary Purpose
Robotic Decompression
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Robotic laparoscopic decompression of pudendal nerve entrapment
Sponsored by
About this trial
This is an interventional treatment trial for Robotic Decompression
Eligibility Criteria
Inclusion Criteria:
- Age 18 - 70 years old
- Pudendal neuralgia according to Nantes criteria
- pudendal nerve entrapment reachable with robotic transperitoneal approach
Exclusion Criteria:
- bilateral pain
- history of pain ≥ 18 months
Sites / Locations
- Service d'urologie
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Non-invasive
Robotic laparoscopic decompression
Arm Description
Neuropathic drugs Pudendal infiltration
Robotic laparoscopic decompression of pudendal nerve entrapment.
Outcomes
Primary Outcome Measures
Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points. (0 no pain -10 extreme pain )
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
Full Information
NCT ID
NCT03876977
First Posted
March 12, 2019
Last Updated
October 19, 2021
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT03876977
Brief Title
Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia
Acronym
ERIS
Official Title
Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
recruitments difficulties
Study Start Date
August 8, 2020 (Actual)
Primary Completion Date
September 23, 2021 (Actual)
Study Completion Date
September 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Robotic Decompression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-invasive
Arm Type
No Intervention
Arm Description
Neuropathic drugs Pudendal infiltration
Arm Title
Robotic laparoscopic decompression
Arm Type
Experimental
Arm Description
Robotic laparoscopic decompression of pudendal nerve entrapment.
Intervention Type
Procedure
Intervention Name(s)
Robotic laparoscopic decompression of pudendal nerve entrapment
Intervention Description
Robotic laparoscopic decompression of pudendal nerve entrapment.
Transperitoneal Laparoscopic Robotic assistance
Primary Outcome Measure Information:
Title
Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points. (0 no pain -10 extreme pain )
Description
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.
Time Frame
3-months after surgery or surveillance
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 - 70 years old
Pudendal neuralgia according to Nantes criteria
pudendal nerve entrapment reachable with robotic transperitoneal approach
Exclusion Criteria:
bilateral pain
history of pain ≥ 18 months
Facility Information:
Facility Name
Service d'urologie
City
Strasbourg
ZIP/Postal Code
67000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia
We'll reach out to this number within 24 hrs