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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Pelvic floor muscle physiotherapy 5x/week for 6-weeks.
GF Strong Rehabilitation Centre
Vancouver, British Columbia, Canada
RECRUITINGFeasibility - 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.
Time frame: Through study completion, an average of 8 months
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.
Time frame: Through study completion, an average of 8 months
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.
Time frame: Through study completion, an average of 8 months
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.
Time frame: Through study completion, an average of 8 months
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.
Time frame: Through study completion, an average of 8 months
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.).
Time frame: Through study completion, an average of 8 months
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.
Time frame: Through study completion, an average of 8 months
International Index of Erectile Function (IIEF) Questionnaire
Male participants will be asked to complete the IIEF questionnaire which askes 15 questions to clinically assess sexual health in 5 domains, each with their own score range: erectile function (0-30), orgasmic function (0-10), sexual desire (0-10), intercourse satisfaction (0-15), overall satisfaction (0-10). A lower score represents greater dysfunction or dissatisfaction in any of the subdomains.
Time frame: Through study completion, an average of 8 months
Female Sexual Function Index (FSFI) Questionnaire
Female participants will be asked to complete the FSFI questionnaire, which asks 19 questions to clinically assess sexual health in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The total score on this questionnaire ranges from 0 to 36, with lower scores indicating greater dysfunction, dissatisfaction, or pain.
Time frame: Through study completion, an average of 8 months
Sexual Quality of Life Questionnaire - Male/Female (SQoL)
Participants will complete the sex-specific version of this questionnaire corresponding to their sex. The male version includes 11 items and the female version includes 18 items, with respondents rating their level of agreement or disagreement with each statement. Total scores range from 11 to 66 for males and 18 to 108 for females. In both versions, lower scores reflect poorer sexual quality of life.
Time frame: Through study completion, an average of 8 months
S4/5 Questionnaire
Participants will be asked to complete a brief questionnaire that asks about their sensation at the S4/5 dermatomes (near and just inside the anal canal), and their ability to perform voluntary anal contractions. This questionnaire is not scored and will be reported descriptively.
Time frame: Through study completion, an average of 8 months
Pelvic Floor Electromyography
PFM function (i.e., endurance and motor control) will be assessed using surface electromyography (EMG). Two pairs of disposable EMG electrodes will be placed perianally to record bilaterally from the pelvic floor. Additional surface EMG sensors will be placed bilaterally over other muscles of the core (e.g. abdominals, glutes). Participants will be instructed to attempt a maximal, isolated PFM contraction (Kegel). The research team will provide standardized, sex-specific instructions for performing this movement. If the participant can perform an isolated PFM contraction, we will assess their motor control by asking them to perform a series of rapid contract-relax cycles. We will also assess endurance by asking them to try to hold a PFM contraction for up to 1 minute. All maneuvers may be recorded up to 3 times.
Time frame: From enrollment to the end of treatment at 6-weeks, or discharge from inpatient care
Ultrasound Assessment
The PFM 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 obtained while the participant is at rest and during PFM contractions.
Time frame: From enrollment to the end of treatment at 6-weeks, or discharge from inpatient care
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