About this trial
The goal of this trial is to learn about the feasibility and benefits of delivering a pelvic floor muscle training program to people with motor-incomplete spinal cord injury. The main questions it aims to answer are:
1. To evaluate the feasibility of delivering a pelvic floor muscle training program to people with spinal cord injury. The investigators will examine recruitment rate, compliance and adherence to the intervention and other study protocols, adverse events, and participant perspectives of the study protocols. 2. To explore the potential effectiveness of pelvic floor muscle training on pelvic floor, bladder, bowel, and sexual function.
Participants will be asked to complete a pelvic floor muscle training program for 3 months. At the beginning, middle, and end of the program, researchers will conduct a series of tests to determine the feasibility and potential effectiveness of this program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Are at least 19 years of age.
Have a non-progressive, motor-incomplete spinal cord injury that is at or above the T12 neurological level at least 12 months ago.
Have symptoms of bladder, bowel, and/or sexual dysfunction that are caused by your spinal cord injury.
Have stable management of spinal cord related secondary health concerns (e.g., spasticity, neuropathic pain).
Disqualifiers
Are currently pregnant, have been pregnant within the past 6 months, or are planning to become pregnant in the next 6 months.
Have had urogenital surgery within the past 12 months.
Have received Botox bladder injections within the past 4 weeks, or anticipate receiving an injection in the next 6 months.
Have presence of severe medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to pressure sores, cardiovascular disease, and unmanaged diabetes.
Trial design
Single group
Treatments tested in this trial
Pelvic Floor Muscle Training
BehavioralPelvic floor muscle training 5x/week for 12-weeks
Treatment groups
Trial outcomes
Primary outcomes
Feasibility - Recruitment Rate
Recruitment rate will be evaluated by number of participants approached, screened for eligibility, as well as reasons for exclusions.
Feasibility - Compliance
Compliance will be tracked by the adherence of participants to the prescribed exercise program, with reasons for missed sessions or drop-outs noted.
Feasibility - Adverse Events
Any adverse events to study protocols will be recorded.
Feasibility - Acceptability
The acceptability of the intervention will be evaluated using a 7-point Likert scale to rate participants' enjoyment of the exercise program and whether they felt the program was beneficial for improving their bladder, bowel, and/or sexual function.
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 behavior, psychosocial impact, and social embarrassment.
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.
3-Day Bladder Diary
Participants will be asked to record information regarding their fluid intake (i.e., time, volume, and type) and voids (i.e., time, volume, leaks, and pad change) for three days. The investigators will use the combined information on intake and voids to make a clinical summary of the participants urinary function.
Timed Bowel Movement
Participants will be asked to 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, etc).
Sponsors and contacts
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