Clinical Trials Directory

Trials / Terminated

TerminatedNCT03876977

Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia

Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia: A Randomized Controlled Trial

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
1 (actual)
Sponsor
University Hospital, Strasbourg, France · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
PROCEDURERobotic laparoscopic decompression of pudendal nerve entrapmentRobotic laparoscopic decompression of pudendal nerve entrapment. Transperitoneal Laparoscopic Robotic assistance

Timeline

Start date
2020-08-08
Primary completion
2021-09-23
Completion
2021-09-23
First posted
2019-03-15
Last updated
2021-10-22

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03876977. Inclusion in this directory is not an endorsement.