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Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia

NCT03876977 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-10-22

No results posted yet for this study

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

  • Robotic Decompression

Interventions

PROCEDURE

Robotic laparoscopic decompression of pudendal nerve entrapment

Robotic laparoscopic decompression of pudendal nerve entrapment. Transperitoneal Laparoscopic Robotic assistance

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-08
Primary Completion
2021-09-23
Completion
2021-09-23

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03876977 on ClinicalTrials.gov