Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia

Robotic Decompression Clinical Trial

— ERIS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03876977
• Other study ID #: 7253
• Status: Terminated
• Phase: N/A
• Start date: August 8, 2020
• Est. completion date: September 23, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 23, 2021
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Pudendal Neuralgia
• Robotic Decompression

Intervention

Procedure:
• Robotic laparoscopic decompression of pudendal nerve entrapment
Robotic laparoscopic decompression of pudendal nerve entrapment. Transperitoneal Laparoscopic Robotic assistance

Locations

Country	Name	City	State
France	Service d'urologie	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3-months after surgery or surveillance