Transcutaneous Spinal Cord Stimulation With Bladder and Pelvic Floor Muscle Training

RNOH RIC

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Other: Bladder and Pelvic Floor Muscle Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05504200

304762

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Supra-sacral spinal cord injury over 6 months ago
• Previous urodynamics and management by the Neuro-urology Consultants
• Proven NDO from latest urodynamics

Exclusion criteria

• 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
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

15 participants in 2 patient groups

Bladder and Pelvic Floor Muscle Training

Experimental group

Description:

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.

Treatment:

Other: Bladder and Pelvic Floor Muscle Training

Control

No Intervention group

Description:

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.