Clinical trial · Interventional
Intraoperative Neuromonitoring of Sacral Reflexes to Predict Post Operative Function in Patients Undergoing Sacrectomy for Pelvic Bone Malignancy or Patients Undergoing Spinal Procedures Without Sacral Root Involvement
Phase 2a Prospective Study of Intraoperative Neuromonitoring of the Bulbocavernosus and External Urethral Sphincter Reflexes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial tests how well monitoring the sacral reflexes during surgery (intraoperatively) works to predict the post operative function for patients undergoing removal of the lowest part of the spine (sacrectomy) for pelvic bone cancers or patients undergoing spinal procedures. These surgical procedures can lead to damage to sacral root nerves which can result in impairment to the lower extremities, bowel, bladder, and sexual function. Intraoperative monitoring of sacral reflexes can provide objective, real-time information about pelvic nerve function during surgery. This can aid surgical decision-making and help surgeons better prepare patients to understand the changes that may have occurred to their function as a result of surgery. Intraoperative neuromonitoring may work well to predict postoperative function in patients undergoing sacrectomy for pelvic bone malignancy or patients undergoing spinal procedures.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Neoplasm | Bone Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Metastatic Malignant Neoplasm in the Bone | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative Nerve Monitoring | Procedure | — | UNRESOLVED |
| Surgical Procedure | Procedure | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (Intraoperative neuromonitoring)
- description
- Patients undergo neuromonitoring of the sacral reflexes at predefined time points during standard of care surgery.
- interventionNames
- Procedure: Intraoperative Nerve Monitoring
- Procedure: Surgical Procedure
- Other: Survey Administration
Primary outcomes (1)
- measure
- Reproducible and interpretable bulbocavernosus reflex (BCR) and external urethral sphincter (EUS) reflex responses (feasibility)
- timeFrame
- From baseline, Up to 1 year
- description
- Reproducible is defined as the ability to elicit a reflex response on repeated stimulation with consistent waveform presence and morphology at a given timepoint. Interpretable is defined as a recorded reflex response that is distinguishable from background noise and artifact and permits determination of response presence or absence and measurement of latency and amplitude. A two-sided 95% Clopper-Pearson confidence interval will be provided as a measure of precision.
Secondary outcomes (14)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative. * Assent, when appropriate, will be obtained per institutional guidelines * Age: ≥ 18 years * Ability to complete study questionnaires * Willingness to comply with all study procedures, including postoperative patient-reported outcome (PRO) assessments * Undergoing surgery at City of Hope involving either: * Complete or partial sacrectomy for primary or metastatic bone tumors, or * Thoracolumbar intervention in which the sacral roots are not exposed or manipulated (reference cohort) Exclusion Criteria: * Prior sacrectomy or prior surgery resulting in complete sacral nerve transection * For thoracolumbar cohort patients, prior diagnosis or patient report of bowel or bladder dysfunction * Cognitive or psychiatric conditions preventing reliable completion of PRO instruments
References
Publications (0)
Data not yet available