Spinal Cord Injuries (SCI)
Conditions
Keywords
Spinal Cord Injury, Physiotherapy, Physical Therapy, Pelvic Floor Muscles
Brief summary
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.
Interventions
BEHAVIORALPelvic Floor Muscle Physiotherapy
Pelvic floor muscle physiotherapy 5x/week for 6-weeks.
Sponsors
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Are at least 19 years of age. 2. Have a traumatic or non-traumatic SCI 3. Are able to perform a voluntary anal contraction 4. Present with bladder or urinary tract dysfunction from SCI 5. Are a current inpatient at GF Strong Rehabilitation Center and are expected to remain as an inpatient for at least 6 weeks after the time of consent. 6. Are able to speak and understand English.
Exclusion criteria
1. Present with symptoms of lower motor neuron injury to the sacral segments (e.g. negative anal and bulbocavernosus reflexes) 2. Present with any other condition besides SCI that impacts the pelvic floor muscles or other pelvic structures 3. Are planning to receive intra-detrusor Botox injections in the next 3 months 4. Have a brain injury or other condition that interferes with their ability to follow instructions 5. Are using a ventilator 6. Have severe and unmanaged spasticity (involuntary muscle tightness or spasms) or contractures (prolonged muscle/joint stiffness) 7. Are unable to tolerate transfers to or lie on a physical therapy table 8. Experience severe pain that interferes with their ability to participate in pelvic floor muscle training
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Recruitment Rate | Through study completion, an average of 8 months | 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 | Through study completion, an average of 8 months | 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) | Through study completion, an average of 8 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Incontinence Quality of Life Questionnaire (I-QoL) | Through study completion, an average of 8 months | 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) | Through study completion, an average of 8 months | 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 | Through study completion, an average of 8 months | 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) | Through study completion, an average of 8 months | 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. |
| International Index of Erectile Function (IIEF) Questionnaire | Through study completion, an average of 8 months | 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. |
| Female Sexual Function Index (FSFI) Questionnaire | Through study completion, an average of 8 months | 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. |
| Sexual Quality of Life Questionnaire - Male/Female (SQoL) | Through study completion, an average of 8 months | 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. |
| S4/5 Questionnaire | Through study completion, an average of 8 months | 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. |
| Pelvic Floor Electromyography | From enrollment to the end of treatment at 6-weeks, or discharge from inpatient care | 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. |
| Ultrasound Assessment | From enrollment to the end of treatment at 6-weeks, or discharge from inpatient care | 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. |
Countries
Canada
Contacts
CONTACTJiho Song
Outcome results
None listed