About this trial
The goal of this clinical study is to determine the feasibility and explore the potential benefits of pelvic floor muscle training during inpatient SCI rehabilitation on urinary, bowel, and sexual function and quality of life in people with SCI. The main questions it aims to answer are:
1. What is the feasibility of recruiting inpatients from SCI rehabilitation to a pelvic floor muscle training program? 2. What is the feasibility and acceptance of the implementation of a pelvic floor muscle training program in SCI inpatient rehabilitation? 3. What are the potential effects of a pelvic floor muscle training program implemented in SCI inpatient rehabilitation on bladder, bowel, and sexual function and quality of life?
Participants will be asked to complete a series of assessments (questionnaires, physical assessments) before and after a 6-week intervention of pelvic floor physical therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Are at least 19 years of age.
Have a traumatic or non-traumatic SCI
Are able to perform a voluntary anal contraction
Present with bladder or urinary tract dysfunction from SCI
Disqualifiers
Present with symptoms of lower motor neuron injury to the sacral segments (e.g. negative anal and bulbocavernosus reflexes)
Present with any other condition besides SCI that impacts the pelvic floor muscles or other pelvic structures
Are planning to receive intra-detrusor Botox injections in the next 3 months
Have a brain injury or other condition that interferes with their ability to follow instructions
Trial design
Single group
Treatments tested in this trial
Pelvic Floor Muscle Physiotherapy
BehavioralPelvic floor muscle physiotherapy 5x/week for 6-weeks.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility - Recruitment Rate
Recruitment Rate will be evaluated by the number of participants approached, screened for eligibility, and invited to enroll in the study, relative to the number of overall inpatients admitted to the GF Strong Rehabilitation Center SCI unit. We will document the number of participants who enrolled, declined enrollment, or did not respond to our invitation to enroll, as well as the reasons for not enrolling when available.
Feasibility - Compliance
Compliance will be tracked by the number of participants who underwent the intervention, as well as their adherence to the prescribed exercise program (attendance to supervised sessions and diaries), with reasons for missed sessions or drop-outs noted.
Feasibility - Acceptability (Perceived Acceptability Questionnaire)
Acceptability of the intervention will be assessed using a study-specific questionnaire, the Perceived Acceptability Questionnaire, developed for this study. The questionnaire aims to capture participants' enjoyment of the PFMT program and their perceptions of its benefits for urinary, bowel, and sexual health. Each item is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree), with higher scores reflecting greater perceived acceptability and benefit.
Secondary outcomes
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 behaviour, psychosocial impact, and social embarrassment. The total score on this questionnaire ranges from 0 to 100, with higher scores indicating a higher quality of life.
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. The total score on this questionnaire ranges from 0 to 74, with lower scores indicating less severe symptoms.
Timed Bowel Routine
Participants will be asked 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, help of another person, etc.).
Neurogenic Bowel Dysfunction Score (NBDS)
Participants will be asked to complete the NBDS questionnaire, which asks 11 questions to clinically assess the severity of their bowel dysfunction symptoms. The total score on this questionnaire ranges from 0 to 47, with higher scores indicating greater bowel dysfunction symptoms.
Sponsors and contacts
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University of British Columbia
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator