An interventional study of Pelvic Floor Muscle Training in Spinal Cord Injury, sponsored by University of British Columbia. Recruiting at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
The goal of this trial is to learn about the feasibility and benefits of delivering a pelvic floor muscle training program to people with motor-incomplete spinal cord injury. The main questions it aims to answer are:
Participants will be asked to complete a pelvic floor muscle training program for 3 months. At the beginning, middle, and end of the program, researchers will conduct a series of tests to determine the feasibility and potential effectiveness of this program.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's planned enrollment of 30 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Pelvic Floor Muscle Training
Pelvic floor muscle training 5x/week for 12-weeks
Feasibility - Recruitment Rate
Recruitment rate will be evaluated by number of participants approached, screened for eligibility, as well as reasons for exclusions.
Time frame: Through study completion, up to 12 weeks
Feasibility - Compliance
Compliance will be tracked by the adherence of participants to the prescribed exercise program, with reasons for missed sessions or drop-outs noted.
Time frame: Through study completion, up to 12 weeks
Feasibility - Adverse Events
Any adverse events to study protocols will be recorded.
Time frame: Through study completion, up to 12 weeks
Feasibility - Acceptability
The acceptability of the intervention will be evaluated using a 7-point Likert scale to rate participants' enjoyment of the exercise program and whether they felt the program was beneficial for improving their bladder, bowel, and/or sexual function.
Time frame: Through study completion, up to 12 weeks
Incontinence Quality of Life Questionnaire (I-QoL)
Participants will be asked to respond to 22 questions about how urinary incontinence impacts their quality of life using a 5-point scale with values ranging from 1 (extremely) to 5 (not at all). The questionnaire probes three subdomains of how incontinence may affect quality of life: avoidance and limiting behavior, psychosocial impact, and social embarrassment.
Time frame: From enrollment to within 2 weeks of completing the study intervention
Neurogenic Bladder Symptoms Score (NBSS)
Participants will be asked to respond to 24 questions regarding the severity of their bladder symptoms secondary to neurological injury. Questions cover three subdomains: incontinence, storage and voiding, and consequences.
Time frame: From enrollment to within 2 weeks of completing the study intervention
3-Day Bladder Diary
Participants will be asked to record information regarding their fluid intake (i.e., time, volume, and type) and voids (i.e., time, volume, leaks, and pad change) for three days. The investigators will use the combined information on intake and voids to make a clinical summary of the participants urinary function.
Time frame: From enrollment to within 2 weeks of completing the study intervention
Timed Bowel Movement
Participants will be asked to how long their bowel movements take, and what (if any) aids they used to complete the bowel movement (e.g. suppository, laxatives, digital stimulation/evacuation, etc).
Time frame: From enrollment to within 2 weeks of completing the study intervention
Neurogenic Bowel Dysfunction Score (NBDS)
Participants will be asked to complete the NBDS which asks 11 questions to clinically assess the severity of their bowel dysfunction symptoms. Results of this questionnaire provide a score from 0 to 47, where a higher score represents more severe bowel symptoms.
Time frame: From enrollment to within 2 weeks of completing the study intervention
International Index of Erectile Function (IIEF) Questionnaire (Males only)
Male participants will be asked to complete the IIEF questionnaire which askes 15 questions to clinically assess sexual health in 5 domains: erectile function (possible score of 0-30), orgasmic function (possible score of 0-10), sexual desire (possible score of 0-10), intercourse satisfaction (possible score of 0-15), overall satisfaction (possible score of 0-10). In all domains, a higher score represents more severe sexual dysfunction.
Time frame: From enrollment to within 2 weeks of completing the study intervention
Female Sexual Function Index (FSFI) Questionnaire (Females Only)
Female participants will be asked to complete the FSFI questionnaire which askes 19 questions to clinically assess sexual health in 6 domains: desire (possible score of 1.2-6), arousal (possible score of 0-6), lubrication (possible score of 0-6), orgasm (possible score of 0-6), satisfaction (possible score of 0.8-6), and pain (possible score of 0-6). In all domains, a higher score represents a less sexual dysfunction.
Time frame: From enrollment to within 2 weeks of completing the study intervention
Sexual Quality of Life Questionnaire - Male/Female
Male and female participants will both be asked to complete their sex-specific version of this questionnaire. This questionnaire asks respondents to rate 11 statements (male, possible score of 11-66) or 18 statements (female, possible score of 18-108) according to how much they agree or disagree with it. For both the male and female version of the questionnaire, a higher score represents better sexual quality of life.
Time frame: From enrollment to within 2 weeks of completing the study intervention
Pelvic Floor Electromyography
PFM function (i.e., endurance and motor control) will be assessed using surface electromyography (EMG). Disposable surface electrodes will be placed perianally to record from the pelvic floor muscles, and other electrodes will be placed over the relevant muscles in the trunk and legs. Participants will be asked to attempt various contractions of their pelvic floor muscles including a maximal, isolated pelvic floor contraction; a sustained pelvic floor contraction to assess endurance; and a rapid contract-relaxation task to assess motor control.
Time frame: From enrollment to within 2 weeks of completing the study intervention
Effectiveness of Cueing
Researchers will ask participants about their perceived effectiveness of verbal instructions and feedback strategies used in the pelvic floor muscle training sessions for facilitating voluntary activation of the pelvic floor.
Time frame: From enrollment to within 2 weeks of completing the study intervention
Transcranial Magnetic Stimulation (TMS) Assessment
The investigators will assess the connection of the neural pathways between the brain and pelvic floor using transcranial magnetic stimulation (TMS). TMS will be delivered over the primary motor cortex in the brain, and motor evoked potentials (MEPs) will be recorded using surface electromyography from the pelvic floor. Participants will be instruction to maintain a sub-maximal contraction of the pelvic floor during the experiment, while TMS pulses are delivered at a variety of intensities.
Time frame: From enrollment to within 2 weeks of completing the study intervention
Pudendal Somatosensory Evoked Potential (SEP) Assessment
Pudendal nerve function will be assessed through an somatosensory evoked potential (SEP) assessment. Non-painful electrical stimulations of up to 1ms in duration will be delivered to the pudendal nerve via the electrodes placed over the genitals while the investigators simultaneously use an electroencephalography (EEG) cap to record from the somatosensory cortex.
Time frame: From enrollment to within 2 weeks of completing the study intervention
Transperineal Ultrasound
Pelvic floor muscle function will be assessed through transperineal ultrasound. An ultrasound probe will be placed on the perineum to visualize the pelvic floor and other relevant pelvic structures (e.g. bladder, urethra, vaginal canal, sphincters, pelvic bones). Ultrasound images and recordings will be taken while the participant is at rest and as they attempt PFM contractions.
Time frame: From enrollment to within 2 weeks of completing the study intervention
Plan to share: No
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University of British Columbia