Restoration of Bladder Function in Spinal Cord Injury

NCT05968352 | Withdrawn

• 1 other identifier: IRAS 260021
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to develop improved methods of restoring function to the neurogenic bladder, using electrical stimulation without cutting nerves in patients with spinal cord injury. The investigators will test 5-10 subjects with existing sacral anterior root stimulation (SARS) devices and look at the effects of high frequency (up to 600Hz) compared to the usual low frequency stimulation on bladder function. The investigators are particularly interested in whether it is possible to reproduce a 'functional' dorzal rhizotomy using high frequency stimulation of the S2 efferent nerves

Conditions

Bladder Dysfunction; Spinal Cord Injuries

Outcome Measures

Primary Outcomes (7)

• Bladder Pressure

  Urodynamics testing - High frequency SARS

  2-3 hours

• Rectal Pressure

  Urodynamics- High frequency SARS

  2-3 hours

• Detrusor Pressure

  Urodynamics- High frequency SARS

  2-3 hours

• Sphincter Pressure

  Urodynamics1- High frequency SARS

  2-3 hours

• Volume voided

  urodynamics- High frequency SARS

  2-3 hours

• Post-void residual volume

  Urodynamics- High frequency SARS

  2-3 hours

• Voiding Flow Rate

  Urodynamics- High frequency SARS

  2-3 hours

Secondary Outcomes (3)

• Bladder pressure

  2-3 hours

• Bladder Capacity

  2-3 hours

• Reflex incontinence

  2-3 hours

Interventions

Sacral Anterior Root Stimulation (SARS) DEVICE

Comparison of High frequency versus low frequency stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with clinically complete spinal cord injury who have undergone implantation of a Finetech Brindley Bladder Controller, with or without sacral posterior rhizotomy. John Radcliffe Hospital (Oxford), Royal National Orthopaedic Hospital (Stanmore) and Walton Centre (Liverpool) will be both patient identification centres and research sites for this study. Stoke Mandeville Hospital will be an additional patient identification centre, but studies on patients identified there will be conducted at Oxford as patients are generally under joint care between Stoke Mandeville Hospital and Oxford.

You may qualify if:

• Patients with clinically complete spinal cord injury who have undergone implantation of a Finetech Brindley Bladder controller, with or without sacral posterior rhizotomy.
• Male or female, aged 18 years or over.
• Patients willing and able to give informed consent to involvement in the study

You may not qualify if:

• External urethral sphincterotomy
• Patients are taking part in any studies on drugs or devices that alter bladder or autonomic function
• Any other significant comorbidity or illness that would preclude their participation or increase the risk to them of participating in the study

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford

Oxford, Oxon, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 1, 2023
• Study Start: November 18, 2021
• Primary Completion: October 14, 2025
• Study Completion: October 14, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)