Brief ES for Recovery of Autonomic Function in CES (BESCES)

February 17, 2026 updated by: University of Liverpool

Can Brief Perioperative Epidural Electrical Stimulation Improve Recovery of Autonomic Function in Cauda Equina Syndrome

BESCES is a study that aims to explore the feasibility of intraoperative brief epidural electrical stimulation (ES) for patients undergoing routine decompression for cauda equina syndrome. In consenting patients, brief ES will be applied using a CE-marked SCS trial kit once sufficient decompression is achieved. In participants who do not recover function following decompression, brief post-op ES will be applied to see if can facilitate micturition and/or removal of the catheter.

The study will assess:

The feasibility of intervention. If brief ES can facilitate conduction in residual neurons. If brief ES can facilitate neuronal recovery

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Cauda equina syndrome (CES), defined as a compression of nerves controlling bowel, bladder and sexual function due to lumbar disc prolapse has a prevalence of 2 per 100,000 UK population per year. It mostly affects individuals 30-49 years of age. Emergency surgery to decompress the nerves is the mainstay of treatment. Despite adequate decompression, 17% of patients are left incontinent and 50% experience persistent bowel, bladder or sexual dysfunction needing long-term supportive symptomatic management and compromising their social cohesion and economic productivity.

Theoretically, there are two possible ways of improving these functions - improving regeneration of damaged cells and improving conduction in partially damaged/residual cells. The use of perioperative electrical stimulation (ES) has shown significant promise in facilitating recovery in peripheral nerve compression syndromes. Epidural stimulation is routinely used for treating neuropathic pain and there is anecdotal evidence of improved bladder and bowel function in patients with CES who have received epidural spinal cord stimulation for chronic pain.

The overall aim of this feasibility study is to determine if a full definitive RCT is possible. The investigators want to see if it is possible to timely and safely deliver epidural stimulation in patients presenting with bowel, bladder or sexual dysfunction due to cauda equina compression, undergoing emergency lumbar decompression, assess the potential effect size of brief post-decompression ES proximal to the level of compression in facilitating axonal regeneration to support further RCT. The investigators also want to see if brief ES can improve conduction in residual neurons.

40 patients presenting with CES shall be enrolled. At the time of decompression surgery, consenting patients shall receive ES. With standard care, patients who still have symptoms after decompression, remain symptomatic at 1 year. Comparison of functional outcomes post-surgery and at 3, 6 and 12 months will enable assessment of recovery due to axonal regeneration.

Results shall assess the safety and feasibility of doing the study in emergency settings - enrolment and consent issues and assess effect size, this will provide sufficient information and, if successful, will lead to a definitive Randomised Control Trial (RCT).

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L9 7LJ
        • The Walton Centre NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >18.
  • Cauda equina syndrome with bladder, bowel or sexual dysfunction (CES-I or CES-R) secondary to acute lumbar disc prolapse.
  • Selected for emergency surgery.

Exclusion Criteria:

  • No bladder, bowel or sexual dysfunction (Only bilateral radicular symptoms).
  • Previous spinal surgery with risk of adhesions.
  • Multilevel degeneration with inadequate safe space to pass epidural electrode.
  • Pre-existent bladder, bowel or sexual dysfunction.
  • History of peripheral neuropathy.
  • Contraindications to neurostimulation (e.g. pacemaker, immune deficiency, uncontrolled diabetes, sepsis, active pressure sore, spinal cord stimulator in situ).
  • Intraoperative CSF leak.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
All participants
Device: Brief ES at the time of decompression for cauda equina syndrome
In patients operated for acute cauda equina syndrome with autonomic dysfunction epidural ES will be delivered utilising SCS trial electrode. It will be delivered for 10 minutes caudal to compression site and for 60 mins cranial to compression site while the wound is closed and patient recovered.
Device: Brief ES to facilitate mcturition/removal of catheter
In patients who do not fully recover function following decompression, brief ES will be applied before second micturition attempt.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: 6 months
Recruitment rate of 50% or above will be considered sufficient for feasibility of conducting future RCT.
6 months
Pudendal Somatosensory Evoked Potentials (SEP) - amplitude (uV)
Time Frame: Post-operatively and at 3 months.
In participants who do not recover autonomic function, Pudendal Nerve SEP will be performed to assess baseline conduction in residual neurons and recovery rate. Results at 3 months will be compared against baseline.
Post-operatively and at 3 months.
Pudendal Somatosensory Evoked Potentials (SEP) - latency (ms)
Time Frame: Post-operatively and at 3 months.
In participants who do not recover autonomic function, Pudendal Nerve SEP will be performed to assess baseline conduction in residual neurons and recovery rate. Results at 3 months will be compared against baseline.
Post-operatively and at 3 months.
Stimulation parameters - Frequency (Hz)
Time Frame: At the time of the surgery and immediately post-op
Intraoperative stimulation parameters will be set to the motor threshold - visually assessed motor response to stimulation. Post-operative stimulation parameters will be set according to patients response - sensation of motor contraction or paraesthesia. Default frequency is 20 Hz and can be modified in 10Hz increments. Descriptive analysis of these parameters shall enable optimisation of settings in future studies.
At the time of the surgery and immediately post-op
Stimulation parameters - Amplitude (mA)
Time Frame: At the time of the surgery and immediately post-op
Intraoperative stimulation parameters will be set to the motor threshold - visually assessed motor response to stimulation. Post-operative stimulation parameters will be set according to patients response - sensation of motor contraction or paraesthesia. Amplitude is increased in 0.1mA increments until response is ascertained. Maximal safe amplitude is considered to be 15mA. Descriptive analysis of these parameters shall enable optimisation of settings in future studies.
At the time of the surgery and immediately post-op
Stimulation parameters - Pulse width (microseconds)
Time Frame: At the time of the surgery and immediately post-op
Intraoperative stimulation parameters will be set to the motor threshold - visually assessed motor response to stimulation. Post-operative stimulation parameters will be set according to patients response - sensation of motor contraction or paraesthesia. Default pulse width is 100 microseconds and it can be adjusted in 10 microsecond increments. Descriptive analysis of these parameters shall enable optimisation of settings in future studies.
At the time of the surgery and immediately post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Form Incontinence Questionnaire (SFIQ)
Time Frame: On admission and at 3, 6 and 12 months.
The SFIQ consists of 5 items. Items 1 and 5 are Yes/No questions. Item 2 is an 8-question scale with answers ranging from 0 (best) to 3 (worst) each. Item 3 is a scale ranging from 1 (best) to 8 (worst). Item 4 is a scale ranging from 1 (best) to 6 (worst).
On admission and at 3, 6 and 12 months.
Arizona Sexual Experiences Scale (ASEX)
Time Frame: On admission and at 3, 6 and 12 months.
The ASEX consists of 5 questions with answers from 1 (best) to 6 (worst)
On admission and at 3, 6 and 12 months.
Neurogenic Bowel Dysfunction (NBD) Questionnaire
Time Frame: On admission and at 3, 6 and 12 months.
NBD is a 10-question item with a score range from 0 (best) to 47 (worst). A score of 0-6 is considered very minor, 7-9 minor, 10-13 moderate and 14+ severe.
On admission and at 3, 6 and 12 months.
Oswestry Disability Index (ODI)
Time Frame: On admission and at 3, 6 and 12 months.
The ODI assesses disability related to back pain. It is a 10-question item, each scored from 0 (best) to 5 (worst). The total score is between 0 (best) and 50 (worst).
On admission and at 3, 6 and 12 months.
Rand SF-36 Questionnaire
Time Frame: On admission and at 3, 6 and 12 months.
Rand Short Form Health Survey (SF-36) is a 36-question tool, developed at RAND as part of the Medical Outcomes Study. It assesses the quality of life in 9 categories (Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Energy/fatigue, Emotional well-being, Social functioning, Pain, General health, Health change). Each category is scored from 0% (worst) to 100% (best).
On admission and at 3, 6 and 12 months.
Post-void bladder scan (PVBS)
Time Frame: At baseline, post-operative (x3) and at 3 months.
PVBS assesses post-micturition bladder volume. Volume above 200mL suggests incomplete bladder emptying or retention. Trends in PVBS will be assessed post-operatively and at 3-month follow-up in patients with incomplete recovery following the surgery.
At baseline, post-operative (x3) and at 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liverpool

Investigators

  • Study Chair: Andrew Marshall, PhD, University of Liverpool

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Estimated)

September 8, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UoL001787

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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