Spinal Cord InjuriesNCT05504200
Transcutaneous Spinal Cord Stimulation With Bladder and Pelvic Floor Muscle Training
A study testing Bladder and Pelvic Floor Muscle Training in people with Spinal Cord Injuries, run by RNOH RIC at 1 site in United Kingdom.
Trial summary
Spinal Cord Injury (SCI) disrupts signals between the brain and the rest of the body, this includes signals needed to control the bladder and bowels. Spinal cord stimulation (SCS) (electrical stimulation through electrodes placed on the skin over the spine) has shown potential to improve bladder function. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Bladder and Pelvic Floor Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Mar 2022to 4 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Supra-sacral spinal cord injury over 6 months ago
- Previous urodynamics and management by the Neuro-urology Consultants
- Proven NDO from latest urodynamics
Who cannot join
- Participants under 16 years of age
- Non-stable SCI or metastatic cord disease
- Intra-detrusor botulinum toxin injections in previous 6 months
- Bladder infection on day of investigation
- Pregnant or trying for a baby (females)
- Cardiac pacemaker, bladder stimulator or baclofen pump in situ
Show all 14Show fewer
- Metal work at thoraco-lumbar level of stimulation
- Poorly controlled Autonomic Dysreflexia
- Currently involved in a clinical trial
- Previous surgical intervention on bladder/sphincters
- Active sepsis
- Poorly controlled epilepsy. Acceptable where epilepsy is controlled by drugs or there have been no fits experienced for a reasonable period
- Patients with a cancerous tumour in the area of the electrical stimulation
- Patients without the capacity to consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal National Orthopaedic Hospital
Stanmore, HA7 4LP
About this study
Official title: Promoting Restoration of Function of Co-ordinated Bladder Storage and Voiding Following Spinal Cord Injury by Combination of Transcutaneous Spinal Cord Stimulation and Bladder & Pelvic Floor Muscle Training Training
Spinal Cord Injury (SCI) disrupts signals between the brain and the rest of the body, this includes signals needed to control the bladder and bowels. Spinal cord stimulation (SCS) (electrical stimulation through electrodes placed on the skin over the spine) has shown potential to improve bladder function. Additionally pelvic floor muscle training (PFMT), has been shown to help control bladder overactivity and reduce incontinence in people with a SCI.
This study will investigate PFMT with SCS, and its effects on restoring bladder function, and continence. We aim to recruit 25 participants. Those eligible will be patients from the London Spinal Cord Injury Centre with a supra-sacral SCI (>6 months post-injury), aged 16 years old and above.
Read the detailed description
The first five participants who volunteer will be invited to complete 'SCS optimisation'. Testing different SCS electrode positions and stimulation parameters with pelvic floor exercises and during urodynamics (measurement of pressure changes during filling and emptying of the bladder).
For the main study, all participants will complete baseline assessments (week 1) which include: bladder, bowel, sexual function, and quality of life questionnaires, a pelvic floor assessment, and urodynamics. Assessments will be repeated at week 8, and week 14.
After baseline assessments, participants will be randomly allocated to one of two groups. The intervention group will receive 8-weeks of at home PFMT, this will include 3 face-to-face visits, daily text reminders, and a weekly phone call. The control group will continue with usual care for 8-weeks.
At the end of the 8-weeks, all participants will be re-assessed, and will then complete a single session of SCS with urodynamics. Participants will return for their final assessment 6-weeks later (week 14). Participants allocated to the control group will be offered PFMT at the end of the study.
- Conditions
- Spinal Cord Injuries
- Being tested
- Bladder and Pelvic Floor Muscle Training
- Keywords
- Spinal cord stimulation, Pelvic floor physiotherapy, Incontinence, Bladder overactivity, Neurogenic detrusor overactivity
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder and Pelvic Floor Muscle TrainingOther
The intervention group will receive 8-weeks of at home PFMT, this will include 3 face-to-face visits, daily text reminders, and a weekly phone call.
| Study group | Role | What they receive |
|---|---|---|
| Bladder and Pelvic Floor Muscle Training | Experimental | Participants randomised to the intervention group will complete an 8-week bladder and PFMT programme, both at the LSCIC and at home. They will be invited to 3 face-to-face follow up appointments over the 8-weeks, where they will meet with a physiotherapist to check their technique and monitor their progress. At home participants will receive a daily text reminder to complete their PFM training, they will also receive a weekly phone call from a member of the research team who will check how they are managing and whether they have any questions. At the end of the programme, participants will be asked to repeat the questionnaires and have their pelvic floor re-assessed. Following this, they will complete the urodynamic investigation with tSCS. Receives: Other: Bladder and Pelvic Floor Muscle Training |
| Control | No intervention | Participants randomised to the control group will continue with their usual care for 8-weeks. They will return to repeat their baseline questionnaires and have their pelvic floor re-assessed. Finally, they will complete tSCS bladder filling and emptying cycles with urodynamics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum cystometric capacity (MCC) from baseline to follow up
Bladder capacity from Cystometrogram/Urodynamic procedures (ml)
Measured: Week 1, 8 and 14
Change in maximum detrusor pressure during voiding (MDPvoid) from baseline to follow up
Voiding detrusor pressure measured from Cystometrogram/Urodynamic procedures (cmH20)
Measured: Week 1, 8 and 14
Change in bladder voiding efficiency from baseline to follow up
Bladder voiding efficiency measured from Cystometrogram/Urodynamic procedures, [[volume voided/volume voided+post void residual)*100] (%)
Measured: Week 1, 8 and 14
Secondary outcomes (7)
Pelvic Floor Oxford Grading Score
Measure of pelvic floor muscle strength, graded 0-5
Measured: Week 1, 8 and 14
The Neurogenic Bladder Symptom Score (NBSS)
Validated 24-item questionnaire, three domains: incontinence, storage and voiding, consequences (score 0-28)
Measured: Week 1, 8 and 14
Neurogenic Bowel Dysfunction Score (NBDS)
Bowel dysfunction questionnaire, includes questions on bowel symptoms, medication, and incontinence (score 0-47)
Measured: Week 1, 8 and 14
Arizona Sexual Experiences Scale (ASEX)
Five-item rating scale measuring sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm (Score 3-30)
Measured: Week 1, 8 and 14
Quality of Life Questionnaire EQ-5D-5L
Five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scoring 1-5 on each dimension, and a VAS scale of overall health 0-100.
Measured: Week 1, 8 and 14
The Qualiveen Questionnaire
30-item questionnaire, with health-related quality of life questions specific to individuals with neurogenic urinary dysfunction. Total score is mean of eight scores: bother with limitations, fears, feelings, and frequency of limitations.
Measured: Week 1, 8 and 14
Electromyography (EMG) of resting tone and maximum voluntary pelvic floor contraction
Use of vaginal/anal probe to capture resting tone and maximum voluntary pelvic floor contraction (mV)
Measured: Week 1, 8 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start16 Mar 2022
- Primary completion4 Sep 2023
- Study completion4 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- RNOH RIC
- Sponsor type
- University, hospital or other
- Collaborators
- International Spinal Research Trust
- Responsible party
- Sponsor-investigator, RNOH RIC, Royal National Orthopaedic Hospital NHS Trust
- Investigators
- Frank Lee, Principal investigator, Royal National Orthopaedic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504200
- Sponsor's protocol ID
- 304762
- Status last verified
- Jun 2024
- First submitted
- 15 Aug 2022
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herrity AN, Aslan SC, Mesbah S, Siu R, Kalvakuri K, Ugiliweneza B, Mohamed A, Hubscher CH, Harkema SJ. Targeting bladder function with network-specific epidural stimulation after chronic spinal cord injury. Sci Rep. 2022 Jul 1;12(1):11179. doi: 10.1038/s41598-022-15315-2.
PubMed 35778466Gad PN, Kreydin E, Zhong H, Latack K, Edgerton VR. Non-invasive Neuromodulation of Spinal Cord Restores Lower Urinary Tract Function After Paralysis. Front Neurosci. 2018 Jun 29;12:432. doi: 10.3389/fnins.2018.00432. eCollection 2018.
PubMed 30008661Doherty S, Vanhoestenberghe A, Duffell L, Hamid R, Knight S. A Urodynamic Comparison of Neural Targets for Transcutaneous Electrical Stimulation to Acutely Suppress Detrusor Contractions Following Spinal Cord Injury. Front Neurosci. 2019 Dec 17;13:1360. doi: 10.3389/fnins.2019.01360. eCollection 2019.
PubMed 31956301Doherty SP, Vanhoestenberghe A, Duffell LD, Hamid R, Knight SL. Ambulatory urodynamic monitoring assessment of dorsal genital nerve stimulation for suppression of involuntary detrusor contractions following spinal cord injury: a pilot study. Spinal Cord Ser Cases. 2020 Apr 30;6(1):30. doi: 10.1038/s41394-020-0279-4.
PubMed 32355163Xu L, Fu C, Zhang Q, Xiong F, Peng L, Liang Z, Chen L, He C, Wei Q. Efficacy of biofeedback, repetitive transcranial magnetic stimulation and pelvic floor muscle training for female neurogenic bladder dysfunction after spinal cord injury: a study protocol for a randomised controlled trial. BMJ Open. 2020 Aug 5;10(8):e034582. doi: 10.1136/bmjopen-2019-034582.
PubMed 32759239Elmelund M, Biering-Sorensen F, Due U, Klarskov N. The effect of pelvic floor muscle training and intravaginal electrical stimulation on urinary incontinence in women with incomplete spinal cord injury: an investigator-blinded parallel randomized clinical trial. Int Urogynecol J. 2018 Nov;29(11):1597-1606. doi: 10.1007/s00192-018-3630-6. Epub 2018 Mar 24.
PubMed 29574482Vasquez N, Knight SL, Susser J, Gall A, Ellaway PH, Craggs MD. Pelvic floor muscle training in spinal cord injury and its impact on neurogenic detrusor over-activity and incontinence. Spinal Cord. 2015 Dec;53(12):887-9. doi: 10.1038/sc.2015.121. Epub 2015 Aug 4.
PubMed 26238317
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Restoration of Function of Co-ordinated Bladder Storage and Voiding Following Spinal Cord Injury by Combination of Transcutaneous Spinal Cord Stimulation and Bladder & Pelvic Floor Muscle Training Training
- ClinicalTrials.gov ID
- NCT05504200
- Acronym / sponsor ID
- 304762
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal cord stimulation, Pelvic floor physiotherapy, Incontinence, Bladder overactivity, Neurogenic detrusor overactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- RNOH RICUniversity, hospital or other
- Collaborators
- International Spinal Research Trust
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 4 Sep 2023 (actual)
- Study completion
- 4 Sep 2023 (actual)
- First posted
- 17 Aug 2022 (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.
Spinal Cord Injury (SCI) disrupts signals between the brain and the rest of the body, this includes signals needed to control the bladder and bowels. Spinal cord stimulation (SCS) (electrical stimulation through electrodes placed on the skin over the spine) has shown potential to improve bladder function. Additionally pelvic floor muscle training (PFMT), has been shown to help control bladder overactivity and reduce incontinence in people with a SCI.
This study will investigate PFMT with SCS, and its effects on restoring bladder function, and continence. We aim to recruit 25 participants. Those eligible will be patients from the London Spinal Cord Injury Centre with a supra-sacral SCI (>6 months post-injury), aged 16 years old and above.
Detailed description
The first five participants who volunteer will be invited to complete 'SCS optimisation'. Testing different SCS electrode positions and stimulation parameters with pelvic floor exercises and during urodynamics (measurement of pressure changes during filling and emptying of the bladder).
For the main study, all participants will complete baseline assessments (week 1) which include: bladder, bowel, sexual function, and quality of life questionnaires, a pelvic floor assessment, and urodynamics. Assessments will be repeated at week 8, and week 14.
After baseline assessments, participants will be randomly allocated to one of two groups. The intervention group will receive 8-weeks of at home PFMT, this will include 3 face-to-face visits, daily text reminders, and a weekly phone call. The control group will continue with usual care for 8-weeks.
At the end of the 8-weeks, all participants will be re-assessed, and will then complete a single session of SCS with urodynamics. Participants will return for their final assessment 6-weeks later (week 14). Participants allocated to the control group will be offered PFMT at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder and Pelvic Floor Muscle Training | Experimental | Other: Bladder and Pelvic Floor Muscle TrainingParticipants randomised to the intervention group will complete an 8-week bladder and PFMT programme, both at the LSCIC and at home. They will be invited to 3 face-to-face follow up appointments over the 8-weeks, where they will meet with a physiotherapist to check their technique and monitor their progress. At home participants will receive a daily text reminder to complete their PFM training, they will also receive a weekly phone call from a member of the research team who will check how they are managing and whether they have any questions. At the end of the programme, participants will be asked to repeat the questionnaires and have their pelvic floor re-assessed. Following this, they will complete the urodynamic investigation with tSCS. |
| Control | No intervention | –Participants randomised to the control group will continue with their usual care for 8-weeks. They will return to repeat their baseline questionnaires and have their pelvic floor re-assessed. Finally, they will complete tSCS bladder filling and emptying cycles with urodynamics. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Supra-sacral spinal cord injury over 6 months ago
- Previous urodynamics and management by the Neuro-urology Consultants
- Proven NDO from latest urodynamics
Key exclusion criteria (14 listed)
- Participants under 16 years of age
- Non-stable SCI or metastatic cord disease
- Intra-detrusor botulinum toxin injections in previous 6 months
- Bladder infection on day of investigation
- Pregnant or trying for a baby (females)
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 |
|---|---|---|
| Bladder and Pelvic Floor Muscle TrainingThe intervention group will receive 8-weeks of at home PFMT, this will include 3 face-to-face visits, daily text reminders, and a weekly phone call. | Other | Bladder and Pelvic Floor Muscle Training |
Primary outcome
Change in maximum cystometric capacity (MCC) from baseline to follow up
Time frame: Week 1, 8 and 14
Bladder capacity from Cystometrogram/Urodynamic procedures (ml)
Change in maximum detrusor pressure during voiding (MDPvoid) from baseline to follow up
Time frame: Week 1, 8 and 14
Voiding detrusor pressure measured from Cystometrogram/Urodynamic procedures (cmH20)
Change in bladder voiding efficiency from baseline to follow up
Time frame: Week 1, 8 and 14
Bladder voiding efficiency measured from Cystometrogram/Urodynamic procedures, [[volume voided/volume voided+post void residual)*100] (%)
7 secondary outcomes
Pelvic Floor Oxford Grading Score
Time frame: Week 1, 8 and 14
The Neurogenic Bladder Symptom Score (NBSS)
Time frame: Week 1, 8 and 14
Neurogenic Bowel Dysfunction Score (NBDS)
Time frame: Week 1, 8 and 14
Arizona Sexual Experiences Scale (ASEX)
Time frame: Week 1, 8 and 14
Quality of Life Questionnaire EQ-5D-5L
Time frame: Week 1, 8 and 14
The Qualiveen Questionnaire
Time frame: Week 1, 8 and 14
Electromyography (EMG) of resting tone and maximum voluntary pelvic floor contraction
Time frame: Week 1, 8 and 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Background: PubMed 35778466Herrity AN, Aslan SC, Mesbah S, Siu R, Kalvakuri K, Ugiliweneza B, Mohamed A, Hubscher CH, Harkema SJ. Targeting bladder function with network-specific epidural stimulation after chronic spinal cord injury. Sci Rep. 2022 Jul 1;12(1):11179. doi: 10.1038/s41598-022-15315-2.
- Background: PubMed 30008661Gad PN, Kreydin E, Zhong H, Latack K, Edgerton VR. Non-invasive Neuromodulation of Spinal Cord Restores Lower Urinary Tract Function After Paralysis. Front Neurosci. 2018 Jun 29;12:432. doi: 10.3389/fnins.2018.00432. eCollection 2018.
- Background: PubMed 31956301Doherty S, Vanhoestenberghe A, Duffell L, Hamid R, Knight S. A Urodynamic Comparison of Neural Targets for Transcutaneous Electrical Stimulation to Acutely Suppress Detrusor Contractions Following Spinal Cord Injury. Front Neurosci. 2019 Dec 17;13:1360. doi: 10.3389/fnins.2019.01360. eCollection 2019.
- Background: PubMed 32355163Doherty SP, Vanhoestenberghe A, Duffell LD, Hamid R, Knight SL. Ambulatory urodynamic monitoring assessment of dorsal genital nerve stimulation for suppression of involuntary detrusor contractions following spinal cord injury: a pilot study. Spinal Cord Ser Cases. 2020 Apr 30;6(1):30. doi: 10.1038/s41394-020-0279-4.
- Background: PubMed 32759239Xu L, Fu C, Zhang Q, Xiong F, Peng L, Liang Z, Chen L, He C, Wei Q. Efficacy of biofeedback, repetitive transcranial magnetic stimulation and pelvic floor muscle training for female neurogenic bladder dysfunction after spinal cord injury: a study protocol for a randomised controlled trial. BMJ Open. 2020 Aug 5;10(8):e034582. doi: 10.1136/bmjopen-2019-034582.
- Background: PubMed 29574482Elmelund M, Biering-Sorensen F, Due U, Klarskov N. The effect of pelvic floor muscle training and intravaginal electrical stimulation on urinary incontinence in women with incomplete spinal cord injury: an investigator-blinded parallel randomized clinical trial. Int Urogynecol J. 2018 Nov;29(11):1597-1606. doi: 10.1007/s00192-018-3630-6. Epub 2018 Mar 24.
- Background: PubMed 26238317Vasquez N, Knight SL, Susser J, Gall A, Ellaway PH, Craggs MD. Pelvic floor muscle training in spinal cord injury and its impact on neurogenic detrusor over-activity and incontinence. Spinal Cord. 2015 Dec;53(12):887-9. doi: 10.1038/sc.2015.121. Epub 2015 Aug 4.
- 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. This study is not recruiting at the moment.
Frank Lee principal investigator
Royal National Orthopaedic Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder and Pelvic Floor Muscle Training in people with Spinal Cord Injuries, run by RNOH RIC 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 3 inclusion and 14 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: finished, as of the sponsor's last update on 12 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximum cystometric capacity (MCC) from baseline to follow up (time frame: Week 1, 8 and 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05504200, which also lists 7 linked publications.
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 12 Jun 2024.