Spinal Cord InjuriesImPRESSNCT06515223
Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury
A study testing Epidural Spinal Cord Stimulation in people with Spinal Cord Injuries and Neuromodulation, run by University College, London at 1 site in United Kingdom.
Trial summary
The investigators will recruit up to 20 volunteers with chronic, supra-sacral SCI. Following screening, eligible participants will enter 'Phase I', they will complete baseline outcome measures and then have the epidural spinal cord stimulator (eSCS) implanted with either percutaneous or paddle electrodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Neuromodulation, Neurogenic Bladder
- What is being tested?
- Epidural Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Oct 2024to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal Cord Injury (supra-sacral)
- AIS A-D
- >18 years;
- SCI sustained >12 months ago;
- Neurogenic detrusor overactivity (NDO) confirmed on urodynamics;
- Responsive to dorsal genital nerve stimulation
Show all 11Show fewer
- Willing and able to provide informed consent
- Stable medical, physical and psychological condition as considered by the investigators
- Able to understand and interact with the study team in English
- Sufficient upper limb function to operate the device
- Suitably optimised bladder and bowel routine
Who cannot join
- Transected cord or SCI related to a neurodegenerative disease
- Any device or metal work in situ that would exclude the patient from having eSCS implanted
- Intra-detrusor botulinum toxin injections within the last 6 months
- Previous surgical intervention on bladder sphincters
- Any diseases and conditions that would exclude the patient from eSCS and/or surgery, for example, degenerative spinal pathology, syrinx and/or tumor.
- Recurrent urinary tract infection refractory to antibiotics
Show all 10Show fewer
- Women who are pregnant or intending to become pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding, or lack of safe contraception for women of childbearing capacity.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the participant
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Enrolment of the investigator, his/her family members, employees, and other dependent persons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal National Orthopaedic Hospital
Stanmore
Hannah Houliston, PhD, hannah.houliston@nhs.net
About this study
The investigators will recruit up to 20 volunteers with chronic, supra-sacral SCI. Following screening, eligible participants will enter 'Phase I', they will complete baseline outcome measures and then have the epidural spinal cord stimulator (eSCS) implanted with either percutaneous or paddle electrodes. Preoperative and intraoperative testing will determine exact location of electrodes.
Mapping and optimisation of stimulation parameters will be performed simultaneously with urodynamic investigations of bladder function, and anorectal physiology investigations of bowel function. The acute effects of eSCS to suppress bladder overactivity, facilitate voiding, prevent unwanted reflex sphincter activity, and pelvic floor function will guide development of eSCS programmes for use at home.
Read more
In 'Phase II', participants will use eSCS at home for 12-weeks. Participants will also be taught how to perform bladder and pelvic floor muscle training (PFMT) in combination with eSCS.
Outcome measures assessing bladder, bowel, sexual function, quality of life, motor function and spasticity will be captured prior to and following the 12-week intervention, and at 3 and 6 month follow up.
Read the detailed description
Screening:
Following confirmation that participants meet the eligibility criteria, they will undergo extensive screening, to confirm their suitability for eSCS implantation. They will meet with multidisciplinary team members, to ensure they are fully educated about the potential risks, and to manage their expectations of outcomes. They will undergo a urodynamics assessment, following standard protocol. If they have neurogenic detrusor overactivity (NDO), and are responsive to dorsal genital nerve stimulation to supress NDO they will progress to have an MRI.
Phase I:
Baseline measurements will be completed as outlined in 'outcome measures'. Participants will undergo implantation of a Senza implantable pulse generator (Nevro Corp., CA, USA), which is MRI-conditional and multi-programmable, with Surpass Surgical or Percutaneous leads (Nevro Corp., CA, USA). The device will be implanted under the skin either at the abdomen, superior to iliac crest, or buttocks.
Participants will attend three mapping sessions to determine effective stimulation sites and parameters for the lower limbs, bladder, bowel and pelvic floor muscles. An optional cardiovascular mapping session will also be offered. The mapping sessions will generate several eSCS programmes for participants to use at home, which target specific effects: supression of NDO, facilitation of voiding, bowel management, and pelvic floor muscle activation.
Participants will have a pelvic floor examination, and be taught a pelvic floor muscle training programme to complete at home. They will be educated on how to use the above programmes as part of their daily routine.
Phase II:
For the following 12-weeks participants will use their eSCS programmes and complete daily PFMT. At week 3, 6 and 9, they will be invited to attend a face to face pelvic floor clinic, to review their programme and progress their exercises as indicated. Participants will be called once a week by a member of the research team to check how the participant is managing with their device/programmes, identify any issues, and have any questions answered. They will be asked to complete a 3-day bladder diary and up to 14-day bowel diary during this period.
Participants will repeat baseline measures (with urodynamics, anorectal physiology and global perception of improvement measure) at the end of the 12-week home trial.
Participants will be offered for their eSCS device to be explanted or they can continue with this in situ. They will have time to consider this and discuss this with the clinical care team and researchers. Irrespective of decision, with participants consent, the investigators will continue to follow them up 3, and 6 months later.
If participants keep the SCS device following the 12-week home trial, the repeat bladder and bowel diary assessments will be captured during a period of 2-weeks without stimulation. They will then be able to proceed with using this device as normal.
All participants will be invited to take part in an interview to discuss their participation in the trial, and their decision to either keep or remove the SCS device. This will be audio recorded which will be destroyed once transformed into a written script.
Participants will return to RNOH Stanmore to complete re-assessment of outcomes at 3 and 6 months.
At the end of the study, participants will be offered for their eSCS device to be explanted or they can continue with this in situ, with ongoing support from The London Spinal Cord Injury Centre team/service.
- Conditions
- Spinal Cord Injuries, Neuromodulation, Neurogenic Bladder, Neurogenic Bowel, Neurogenic Detrusor Overactivity
- Being tested
- Epidural Spinal Cord Stimulation
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Neurogenic, Neurogenic Bowel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Spinal Cord StimulationDevice
Epidural Spinal Cord Stimulation Mapping and Pelvic Floor Muscle Training
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Implantation of Epidural Spinal Cord Stimulation to target bladder and bowel function. Applied in combination with Pelvic Floor Muscle Training. Receives: Device: Epidural Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximum Cystometric Capacity (bladder capacity) from baseline (week 1) to post intervention (week 16) and follow up (week 28, week 40)
During standard cystometry (retrograde filling of the bladder), maximum cystometric capacity will be defined as the volume emptied from the bladder after each fill.
Measured: Week 1, 16, 28 and 40
Secondary outcomes (14)
Maximum Detrusor Pressure
Maximum recorded detrusor pressure during standard cystometry (retrograde filling of the bladder).
Measured: Week 1, 16, 28 and 40
Rectal and Anal Pressure during Push Manoeuvre
During standard anorectal physiology, London protocol.
Measured: Week 3, 16, 28 and 40
3 day bladder diary
Bladder diary will be completed on clinically used bladder diaries. Participants will record voided volumes, urinary incontinence episodes and daily spasticity for 3 days. This will involve measuring the volume voided each time they urinate over the three days, using provided measuring equipment.
Measured: Week 3, 12, 16, 28 and 40
Up to 14 day bowel diary
Bowel diary will be completed on clinically used bowel diaries. Participants will record type of stool and amount, bowel incontience, bowel management e.g laxatives, use of manual evacuation.
Measured: Week 3, 12, 16, 28 and 40
Questionnaire - Neurogenic Bladder Symptom Score (NBSS)
Participants will be asked to complete the questionnaire in a private room at RNOH Stanmore.
Scored as 3 subscales - incontinence, score 0-12 (higher score, more severe symptoms), storage and voiding, score 0-9 (higher score, more severe symptoms), and consequences, score 0-7 (higher score, more severe symptoms).
Measured: Week 2, 16, 28 and 40
Questionnaire - Urinary Symptom Profile questionnaire
Participants will be asked to complete the questionnaire in a private room at RNOH Stanmore.
Scored as 3 subscales - stress urinary incontinence, score 0-9 (higher score, more severe symptoms), overactive bladder, score 0-21 (higher score, more severe symptoms), and low stream, score 0-9 (higher score, more severe symptoms).
Measured: Week 2, 16, 28 and 40
Questionnaire - Neurogenic Bowel Dysfunction Score (NBDS)
Participants will be asked to complete the questionnaire in a private room at RNOH Stanmore.
Total score, from 0-47 (higher score, more severe symptoms). General satisfaction score 0-10, 0=total dissatisfaction, 10=perfect satisfaction.
Measured: Week 2, 16, 28 and 40
Questionnaire - EQ-5D-5L Quality of Life questionnaire
Participants will be asked to complete the questionnaire in a private room at RNOH Stanmore.
Scored from 1-5 for each health state (1 indicates no problem, 5 indicates unable to/extreme problems). VAS is scored 0-100 (0 refers to 'the worst health you can imagine', 100 refers to 'the best health you can imagine').
Measured: Week 2, 16, 28 and 40
Questionnaire - ISCOS Lower Urinary Tract Dysfunction Dataset (LUTDD)
Participants will be asked to complete the questionnaire in a private room at RNOH Stanmore.
Not a scored questionnaire - obtains information about LUT function.
Measured: Week 2, 16, 28 and 40
Questionnaire - The International Index of Erectile Function (IIEF) or The Female Sexual Function Index (FSFI)
Participants will be asked to complete the questionnaire in a private room at RNOH Stanmore.
IIEF:
Questions scored 0-5 or 1-5, (higher score, more severe symptoms). Total score, minimum 6, maximum 75 (higher score, more severe symptoms).
FSFI:
Questions scored 0-5 or 1-5, (higher score, more severe symptoms). Total score, minimum 2, maximum 36 (higher score, more severe symptoms).
Measured: Week 2, 16, 28 and 40
Questionnaire - Penn Spasm Frequency Scale
Participants will be asked to complete the questionnaire in a private room at RNOH Stanmore.
Frequency score 0-4, (higher score, more severe symptoms). Severity score 1-3, (higher score, more severe symptoms).
Measured: Week 2, 16, 28 and 40
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Sensory and motor examination to determine classification of SCI, level of injury and completeness of the injury.
Measured: Week 2, 16, 28 and 40
Colonic Transit Assessment
A colonic transit study is a test that shows how quickly food passes through the digestive system. Participants will swallow tablets on three consecutive days. On the fourth day, they will have an x-ray.
Measured: Week 2, 12 and 40
Microbiome Testing
Poo sample will be collected by participant, and bacteria present analysed.
Measured: Week 2, 16 and 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start14 Oct 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal National Orthopaedic Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- David Baxter, MD, Principal investigator, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515223
- Sponsor's protocol ID
- 301613
- Acronym
- ImPRESS
- Status last verified
- Oct 2024
- First submitted
- 1 Jul 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06515223
- Acronym / sponsor ID
- ImPRESS / 301613
- Conditions
- Spinal Cord Injuries, Neuromodulation, Neurogenic Bladder, Neurogenic Bowel, Neurogenic Detrusor Overactivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Royal National Orthopaedic Hospital NHS Trust
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will recruit up to 20 volunteers with chronic, supra-sacral SCI. Following screening, eligible participants will enter 'Phase I', they will complete baseline outcome measures and then have the epidural spinal cord stimulator (eSCS) implanted with either percutaneous or paddle electrodes. Preoperative and intraoperative testing will determine exact location of electrodes.
Mapping and optimisation of stimulation parameters will be performed simultaneously with urodynamic investigations of bladder function, and anorectal physiology investigations of bowel function. The acute effects of eSCS to suppress bladder overactivity, facilitate voiding, prevent unwanted reflex sphincter activity, and pelvic floor function will guide development of eSCS programmes for use at home.
In 'Phase II', participants will use eSCS at home for 12-weeks. Participants will also be taught how to perform bladder and pelvic floor muscle training (PFMT) in combination with eSCS.
Outcome measures assessing bladder, bowel, sexual function, quality of life, motor function and spasticity will be captured prior to and following the 12-week intervention, and at 3 and 6 month follow up.
Detailed description
Screening:
Following confirmation that participants meet the eligibility criteria, they will undergo extensive screening, to confirm their suitability for eSCS implantation. They will meet with multidisciplinary team members, to ensure they are fully educated about the potential risks, and to manage their expectations of outcomes. They will undergo a urodynamics assessment, following standard protocol. If they have neurogenic detrusor overactivity (NDO), and are responsive to dorsal genital nerve stimulation to supress NDO they will progress to have an MRI.
Phase I:
Baseline measurements will be completed as outlined in 'outcome measures'. Participants will undergo implantation of a Senza implantable pulse generator (Nevro Corp., CA, USA), which is MRI-conditional and multi-programmable, with Surpass Surgical or Percutaneous leads (Nevro Corp., CA, USA). The device will be implanted under the skin either at the abdomen, superior to iliac crest, or buttocks.
Participants will attend three mapping sessions to determine effective stimulation sites and parameters for the lower limbs, bladder, bowel and pelvic floor muscles. An optional cardiovascular mapping session will also be offered. The mapping sessions will generate several eSCS programmes for participants to use at home, which target specific effects: supression of NDO, facilitation of voiding, bowel management, and pelvic floor muscle activation.
Participants will have a pelvic floor examination, and be taught a pelvic floor muscle training programme to complete at home. They will be educated on how to use the above programmes as part of their daily routine.
Phase II:
For the following 12-weeks participants will use their eSCS programmes and complete daily PFMT. At week 3, 6 and 9, they will be invited to attend a face to face pelvic floor clinic, to review their programme and progress their exercises as indicated. Participants will be called once a week by a member of the research team to check how the participant is managing with their device/programmes, identify any issues, and have any questions answered. They will be asked to complete a 3-day bladder diary and up to 14-day bowel diary during this period.
Participants will repeat baseline measures (with urodynamics, anorectal physiology and global perception of improvement measure) at the end of the 12-week home trial.
Participants will be offered for their eSCS device to be explanted or they can continue with this in situ. They will have time to consider this and discuss this with the clinical care team and researchers. Irrespective of decision, with participants consent, the investigators will continue to follow them up 3, and 6 months later.
If participants keep the SCS device following the 12-week home trial, the repeat bladder and bowel diary assessments will be captured during a period of 2-weeks without stimulation. They will then be able to proceed with using this device as normal.
All participants will be invited to take part in an interview to discuss their participation in the trial, and their decision to either keep or remove the SCS device. This will be audio recorded which will be destroyed once transformed into a written script.
Participants will return to RNOH Stanmore to complete re-assessment of outcomes at 3 and 6 months.
At the end of the study, participants will be offered for their eSCS device to be explanted or they can continue with this in situ, with ongoing support from The London Spinal Cord Injury Centre team/service.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Epidural Spinal Cord StimulationImplantation of Epidural Spinal Cord Stimulation to target bladder and bowel function. Applied in combination with Pelvic Floor Muscle Training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Spinal Cord Injury (supra-sacral)
- AIS A-D
- >18 years;
- SCI sustained >12 months ago;
- Neurogenic detrusor overactivity (NDO) confirmed on urodynamics;
Key exclusion criteria (10 listed)
- Transected cord or SCI related to a neurodegenerative disease
- Any device or metal work in situ that would exclude the patient from having eSCS implanted
- Intra-detrusor botulinum toxin injections within the last 6 months
- Previous surgical intervention on bladder sphincters
- Any diseases and conditions that would exclude the patient from eSCS and/or surgery, for example, degenerative spinal pathology, syrinx and/or tumor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural Spinal Cord StimulationEpidural Spinal Cord Stimulation Mapping and Pelvic Floor Muscle Training | Device | Treatment |
Primary outcome
Change in Maximum Cystometric Capacity (bladder capacity) from baseline (week 1) to post intervention (week 16) and follow up (week 28, week 40)
Time frame: Week 1, 16, 28 and 40
During standard cystometry (retrograde filling of the bladder), maximum cystometric capacity will be defined as the volume emptied from the bladder after each fill.
14 secondary outcomes
Maximum Detrusor Pressure
Time frame: Week 1, 16, 28 and 40
Rectal and Anal Pressure during Push Manoeuvre
Time frame: Week 3, 16, 28 and 40
3 day bladder diary
Time frame: Week 3, 12, 16, 28 and 40
Up to 14 day bowel diary
Time frame: Week 3, 12, 16, 28 and 40
Questionnaire - Neurogenic Bladder Symptom Score (NBSS)
Time frame: Week 2, 16, 28 and 40
Questionnaire - Urinary Symptom Profile questionnaire
Time frame: Week 2, 16, 28 and 40
Questionnaire - Neurogenic Bowel Dysfunction Score (NBDS)
Time frame: Week 2, 16, 28 and 40
Questionnaire - EQ-5D-5L Quality of Life questionnaire
Time frame: Week 2, 16, 28 and 40
Questionnaire - ISCOS Lower Urinary Tract Dysfunction Dataset (LUTDD)
Time frame: Week 2, 16, 28 and 40
Questionnaire - The International Index of Erectile Function (IIEF) or The Female Sexual Function Index (FSFI)
Time frame: Week 2, 16, 28 and 40
Questionnaire - Penn Spasm Frequency Scale
Time frame: Week 2, 16, 28 and 40
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Time frame: Week 2, 16, 28 and 40
Colonic Transit Assessment
Time frame: Week 2, 12 and 40
Microbiome Testing
Time frame: Week 2, 16 and 40
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Baxter, MD principal investigator
National Health Service, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural Spinal Cord Stimulation in people with Spinal Cord Injuries and Neuromodulation, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lynsey Duffell, PhD (0208 385 3787, l.duffell@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximum Cystometric Capacity (bladder capacity) from baseline (week 1) to post intervention (week 16) and follow up (week 28, week 40) (time frame: Week 1, 16, 28 and 40). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.