Exploring the Feasibility and Benefits of Implementing Pelvic Floor Muscle Training During Inpatient Rehabilitation for People With Spinal Cord Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of British Columbia

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Pelvic Floor Muscle Physiotherapy

    Behavioral

    Pelvic floor muscle physiotherapy 5x/week for 6-weeks.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Pelvic Floor Muscle Physical TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Through study completion, an average of 8 months
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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University of British Columbia

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator