TerminatedNot Applicable

Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia

Stopped: recruitments difficulties

France1 participantsStarted 2020-08-08

Plain-language 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

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points. (0 no pain -10 extreme pain )

Timeframe: 3-months after surgery or surveillance

Trial details

NCT IDNCT03876977

SponsorUniversity Hospital, Strasbourg, France

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-23

View on ClinicalTrials.gov More Robotic Decompression trials