CompletedNot Applicable

Nerve Fiber Density in DIE Nodules & Pelvic Pain

Turkey (Türkiye)65 participantsStarted 2022-02-01

Plain-language summary

Deep infiltrating endometriosis (DIE) is a highly symptomatic form of endometriosis linked to severe dysmenorrhea, dyspareunia, dyschezia, dysuria, and chronic pelvic pain. Histologic studies suggest abundant neural elements in DIE nodules, but the relationship between nodule-level nerve fiber density and patient-reported pelvic pain remains insufficiently defined. This retrospective, cross-sectional study with prospective pathology re-review evaluates whether nerve fiber density in surgically excised DIE nodules correlates with pain severity and location. Women aged 18-55 who underwent surgery for DIE after inadequate response to medical therapy are included. Clinical data (demographics, gynecologic history, prior treatments) and standardized pain scores (VAS for pain domains) are abstracted from records. Archived blocks are recut; sections are stained with H\&E and immunolabeled (e.g., SOX-10) to quantify neural profiles and derive a nerve fiber density metric per nodule. Primary endpoint: association between nerve fiber density and pain intensity/localization. Secondary endpoints: relationships with lesion site/depth and other clinicopathologic variables; exploratory discrimination of severe-pain phenotypes. Statistics (χ²/Fisher, t/Mann-Whitney, Kaplan-Meier/Cox if applicable) use two-sided p\<0.05. This minimal-risk study uses existing records and archived tissue only; findings may inform counseling, nerve-sparing surgical planning, and future biomarker-driven, response-adapted trials.

Who can participate

Age range

18 Years – 55 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:Female, 18-55 years of age at time of surgery Surgically treated for deep infiltrating endometriosis (DIE) with curative intent within the study period Histopathologic confirmation of DIE on resected specimen (e.g., rectovaginal septum, uterosacral/cardinal ligaments, parametria, bowel, ureter, bladder, retrocervical/cervicovaginal sites) Availability of archived FFPE tissue blocks adequate for H\&E and immunohistochemistry (e.g., SOX10) to quantify nerve fiber density Documented preoperative pain assessment (e.g., VAS 0-10 for dysmenorrhea, dyspareunia, dyschezia, dysuria, and/or chronic pelvic pain) obtained within ≤3 months prior to index surgery Accessible clinical data in the medical record (demographics, gynecologic history, prior medical/surgical therapies) sufficient for planned analyses IRB approval in place; inclusion under written informed consent or IRB waiver applicable to retrospective data/tissue use - Exclusion Criteria:No surgical resection of DIE (e.g., diagnostic laparoscopy only) or no histopathologic confirmation of DIE Insufficient biospecimen (no/poor-quality FFPE tissue for H\&E/IHC) Missing preoperative pain assessment (no VAS data within ≤3 months before index surgery) Concomitant malignancy of the pelvis/abdominopelvic organs or malignancy treated within the past 5 years Prior pelvic radiotherapy or major pelvic/nerve ablative surgery that precludes meaningful pain attribution Acute pelvic infection at time of assessme…

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

Association between nodule-level nerve fiber density and pelvic pain severity

Timeframe: from 01.02.2022 to june 2025

Trial details

NCT IDNCT07274956

SponsorBaşakşehir Çam & Sakura City Hospital

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2025-06-27

View on ClinicalTrials.gov More Deep Infiltrating Endometriosis, Pelvic Pain, Dysmenorrhea Dyspareunia trials