Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia (ERIS)

University Hospital, Strasbourg, France

Status: Terminated

Conditions: Robotic Decompression

Treatments: Procedure: Robotic laparoscopic decompression of pudendal nerve entrapment

Study type: Interventional

Funder types: Other

Identifiers

NCT03876977

7253

Details and patient eligibility

About

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

Enrollment: 1 patient

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Non-invasive

No Intervention group

Description:

Neuropathic drugs Pudendal infiltration

Robotic laparoscopic decompression

Experimental group

Description:

Robotic laparoscopic decompression of pudendal nerve entrapment.

Treatment:

Procedure: Robotic laparoscopic decompression of pudendal nerve entrapment