TerminatedNot Applicable

Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia

Stopped: recruitments difficulties

France1 participantsStarted 2020-08-08

Plain-language 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

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points. (0 no pain -10 extreme pain )

Timeframe: 3-months after surgery or surveillance

Trial details

NCT IDNCT03876977

SponsorUniversity Hospital, Strasbourg, France

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-23

View on ClinicalTrials.gov More Robotic Decompression trials