TerminatedNot Applicable

Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population

Stopped: End of inclusions

France60 participantsStarted 2018-07-17

Plain-language summary

The purpose of this study is to assess and validate the clinical criteria of sensitization ("Convergences PP criteria") selected by the expert consensus with neurophysiological sensory testing.

Who can participate

Age range

25 Years

Sex

FEMALE

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: * Women \> 25 years, * Pelvic or perineal pain since \> 3 months, * No injury in pelvic imagery or clinical examination that may explain all the pain complaint, * Patient who can understand the protocol, * Patient who agreed and signed the informed consent for participation. Exclusion Criteria: * Poor understanding of French language, * Pregnancy or lactation, * Severe depression (Beck Depression Inventory-Short form \> 16), * Initial pain estimation at 10 on numeric analog scale, * Inadequately cooperating, * Isolated dysmenorrhea, * Deep endometriosis with rectal or bladder lesion, * Genital or bladder infection, * Urogenital tumor history, * Anorectal surgery history a type of digestive resection, * Anal stenosis, * Advanced vaginal prolapse (stage 2 on POP-Q scale), * Post-traumatic stress disorder history, * Deprived of liberty (trusteeship, guardianship).

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

Comparison of pelvic pain threshold

Timeframe: 1 month after inclusion in the study

Trial details

NCT IDNCT03541954

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-14

View on ClinicalTrials.gov More Chronic Pelvic Pain trials