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NCT Number: NCT07707024

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

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.

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Key information

Conditions

Bone Neoplasm Bone Diseases Bone Neoplasms Metastatic Malignant Neoplasm in the Bone Musculoskeletal Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

Location contact

Alana M. Munger

CONTACT

[email protected]

808-384-0975

Alana M. Munger

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVE:

I. To evaluate the feasibility of acquiring analyzable sacral reflex neuromonitoring data at baseline and case closure during surgery.

SECONDARY OBJECTIVES:

I. To characterize sacral reflex parameters amplitude, latency, waveform morphology, and Nerveana Power Index (NPI) at baseline under standardized intraoperative neuromonitoring conditions in patients undergoing spinal procedures without sacral nerve root involvement and patients undergoing sacrectomy.

II. To describe intraoperative changes in sacral reflex parameters from baseline to end-of-case during standardized intraoperative neuromonitoring in patients undergoing sacrectomy.

III. To characterize the relative contribution of individual sacral nerve roots to sacral reflex responses during intraoperative stimulation in patients undergoing sacrectomy.

IV. To characterize longitudinal changes in postoperative functional outcomes in patients undergoing sacrectomy.

EXPLORATORY OBJECTIVES:

I. To explore the association between intraoperative sacral reflex changes and postoperative functional outcomes in patients undergoing sacrectomy.

II. To explore the association between sacrifice of higher- versus lower-contributing sacral nerve roots and postoperative functional outcomes in patients undergoing sacrectomy.

OUTLINE:

Patients undergo neuromonitoring of the sacral reflexes at predefined time points during standard of care surgery.

After completion of study treatment, patients are followed up at 21 days, 6 weeks and 3, 6 and 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraoperative Nerve Monitoring

Procedure

Undergo intraoperative neuromonitoring

Other names: Intraoperative Neuromonitoring, Intraoperative Neurophysiological Monitoring, IONM

Surgical Procedure

Procedure

Undergo standard of care surgery

Other names: Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Reproducible and interpretable bulbocavernosus reflex (BCR) and external urethral sphincter (EUS) reflex responses (feasibility)

    Time frame: From baseline, Up to 1 year

    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

  1. Distribution of BCR reflex parameters

    Time frame: From baseline, Up to 1 year

    Amplitude, latency, frequency distribution, etc, measured via intraoperative neuromonitoring (IONM). ), Analyses will first be conducted separately within thoracolumber and sacrectomy patient groups. Descriptive statistics will be reported for BCR for each group. Next, to compare the mean values between the two groups, t-test or Mann-Whitney U-test will be implemented depending on the distribution of these parameters. Additionally, within the sacrectomy group, the changes of these parameters from baseline to the end-of-case will be assessed either through paired t-test or Wilcoxon's signed rank test, depending on the distribution of each parameter.

  2. Distribution of EUS reflex parameters

    Time frame: From baseline, Up to 1 year

    Amplitude, latency, frequency distribution, etc, measured via IONM. Analyses will first be conducted separately within thoracolumber and sacrectomy patient groups. Descriptive statistics will be reported for EUS for each group. Next, to compare the mean values between the two groups, t-test or Mann-Whitney U-test will be implemented depending on the distribution of these parameters. Additionally, within the sacrectomy group, the changes of these parameters from baseline to the end-of-case will be assessed either through paired t-test or Wilcoxon's signed rank test, depending on the distribution of each parameter.

  3. Change in BCR reflex parameters

    Time frame: From baseline, Up to 1 year

    Analyses will first be conducted separately within thoracolumber and sacrectomy patient groups. Descriptive statistics will be reported for BCR for each group. Next, to compare the mean values between the two groups, t-test or Mann-Whitney U-test will be implemented depending on the distribution of these parameters. Additionally, within the sacrectomy group, the changes of these parameters from baseline to the end-of-case will be assessed either through paired t-test or Wilcoxon's signed rank test, depending on the distribution of each parameter.

  4. Change in EUS reflex parameters

    Time frame: From baseline, Up to 1 year

    Analyses will first be conducted separately within thoracolumber and sacrectomy patient groups. Descriptive statistics will be reported for EUS for each group. Next, to compare the mean values between the two groups, t-test or Mann-Whitney U-test will be implemented depending on the distribution of these parameters. Additionally, within the sacrectomy group, the changes of these parameters from baseline to the end-of-case will be assessed either through paired t-test or Wilcoxon's signed rank test, depending on the distribution of each parameter.

  5. Relative contribution of individual right sacral nerve roots to BCR amplitude

    Time frame: During intraoperative stimulation, Up to Day 21

    Amplitudes among sacrectomy patients will be descriptively reported.

  6. Relative contribution of individual left sacral nerve roots to BCR amplitude

    Time frame: During intraoperative stimulation, Up to Day 21

    Amplitudes among sacrectomy patients will be descriptively reported.

  7. Relative contribution of individual right sacral nerve roots to EUS amplitude

    Time frame: During intraoperative stimulation, Up to Day 21

    Amplitudes among sacrectomy patients will be descriptively reported.

  8. Relative contribution of individual left sacral nerve roots to EUS amplitude

    Time frame: During intraoperative stimulation, Up to Day 21

    Amplitudes among sacrectomy patients will be descriptively reported.

  9. Bowel function scores

    Time frame: From baseline, Up to 1 year

    Assessed by Memorial Sloan Kettering Bowel Function Instrument. Will be described by graphs and descriptive statistics at each time point.

  10. Bladder function scores

    Time frame: From baseline, up to 1 year

    Assessed by International Consultation on Incontinence Questionnaire. Will be described by graphs and descriptive statistics at each time point.

  11. Sexual function scores

    Time frame: From baseline, up to 1 year

    Assessed by Female Sexual Function Index (female patients only) and International Index of Erectile Function (male patients only). Will be described by graphs and descriptive statistics at each time point.

  12. Lower extremity function

    Time frame: From baseline, up to 1 year

    Assessed by Toronto Extremity Salvage Score for the Lower Extremity. Will be described by graphs and descriptive statistics at each time point.

  13. Quality of life

    Time frame: From baseline, up to 1 year

    Assessed by Functional Assessment of Cancer Therapy-General. Will be described by graphs and descriptive statistics at each time point.

  14. Postoperative urologic function

    Time frame: From baseline, up to 1 year

    Assessed by post-void residual (PVR) or cystometry. Will be described by graphs and descriptive statistics at each time point.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Phase 2a Prospective Study of Intraoperative Neuromonitoring of the Bulbocavernosus and External Urethral Sphincter Reflexes

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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