Exploring the Feasibility and Benefits of Implementing Pelvic Floor Muscle Training During Inpatient Rehabilitation for People With Spinal Cord Injury
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Feasibility - Compliance
Overview
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:
- What is the feasibility of recruiting inpatients from SCI rehabilitation to a pelvic floor muscle training program?
- What is the feasibility and acceptance of the implementation of a pelvic floor muscle training program in SCI inpatient rehabilitation?
- 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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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.
- •Are able to speak and understand English.
Exclusion Criteria
- •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
- •Are using a ventilator
- •Have severe and unmanaged spasticity (involuntary muscle tightness or spasms) or contractures (prolonged muscle/joint stiffness)
- •Are unable to tolerate transfers to or lie on a physical therapy table
- •Experience severe pain that interferes with their ability to participate in pelvic floor muscle training
Arms & Interventions
Pelvic Floor Muscle Physical Therapy
Pelvic floor muscle physical therapy 5/week for 6 weeks.
Intervention: Pelvic Floor Muscle Physiotherapy (Behavioral)
Outcomes
Primary Outcomes
Feasibility - Compliance
Time Frame: 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
Time Frame: Through study completion, an average of 8 months
Acceptability of the intervention will be evaluated using a Likert scale questionnaire to understand participants' enjoyment of the PFMT program and whether they felt the program was beneficial for improving their urinary, bowel, and sexual health function.
Feasibility - Recruitment Rate
Time Frame: 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 - Acceptability (Perceived Acceptability Questionnaire)
Time Frame: 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 Outcomes
- International Index of Erectile Function (IIEF) Questionnaire(Through study completion, an average of 8 months)
- Incontinence Quality of Life Questionnaire (I-QoL)(Through study completion, an average of 8 months)
- Neurogenic Bladder Symptoms Score (NBSS)(Through study completion, an average of 8 months)
- Timed Bowel Routine(Through study completion, an average of 8 months)
- Neurogenic Bowel Dysfunction Score (NBDS)(Through study completion, an average of 8 months)
- Female Sexual Function Index (FSFI) Questionnaire(Through study completion, an average of 8 months)
- Sexual Quality of Life Questionnaire - Male/Female (SQoL)(Through study completion, an average of 8 months)
- S4/5 Questionnaire(Through study completion, an average of 8 months)
- Pelvic Floor Electromyography(From enrollment to the end of treatment at 6-weeks, or discharge from inpatient care)
- Ultrasound Assessment(From enrollment to the end of treatment at 6-weeks, or discharge from inpatient care)
Investigators
Tania Lam
Professor
University of British Columbia