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

October 19, 2021 updated by: University Hospital, Strasbourg, France

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67000
        • Service d'urologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Non-invasive
Neuropathic drugs Pudendal infiltration
Experimental: Robotic laparoscopic decompression
Robotic laparoscopic decompression of pudendal nerve entrapment.
Procedure: Robotic laparoscopic decompression of pudendal nerve entrapment

Robotic laparoscopic decompression of pudendal nerve entrapment.

Transperitoneal Laparoscopic Robotic assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points. (0 no pain -10 extreme pain )
Time Frame: 3-months after surgery or surveillance

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2020

Primary Completion (Actual)

September 23, 2021

Study Completion (Actual)

September 23, 2021

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7253

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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