Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia

University Hospital, Strasbourg, France1 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Robotic Decompression

Interventions

Robotic laparoscopic decompression of pudendal nerve entrapmentPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Service d'urologie

Strasbourg, France

Outcomes

Primary Outcomes

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.

Time frame: 3-months after surgery or surveillance

Data from ClinicalTrials.gov

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