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TerminatedNCT03876977ERISUpdated Oct 22, 2021

Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia

An interventional study of Robotic laparoscopic decompression of pudendal nerve entrapment in Robotic Decompression, sponsored by University Hospital, Strasbourg, France. Terminated at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-10-22.

Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Treatment

Why this study was terminated
recruitments difficulties
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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
02

Conditions studied

  • Robotic Decompression
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 1 is below the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18 - 70 years old
  • Pudendal neuralgia according to Nantes criteria
  • pudendal nerve entrapment reachable with robotic transperitoneal approach

Exclusion criteria

Exclusion Criteria:

  • bilateral pain
  • history of pain ≥ 18 months
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • 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

Interventions

  • ProcedureRobotic laparoscopic decompression of pudendal nerve entrapment

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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Service d'urologie
    Strasbourg, 67000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03876977
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Mar 15, 2019
Start date
Aug 8, 2020
Primary completion
Sep 23, 2021
Completion
Sep 23, 2021
Last update
Oct 22, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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