- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07519928
Exploring the Feasibility and Benefits of Implementing Pelvic Floor Muscle Training During Inpatient Rehabilitation for People With Spinal Cord Injury
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jiho Song
- Phone Number: 604-675-8815
- Email: lamlab@icord.org
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 2G9
- Recruiting
- GF Strong Rehabilitation Centre
-
Contact:
- Amrit Dhaliwal
- Phone Number: 604-675-8815
- Email: amrit.dhaliwal@vch.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pelvic Floor Muscle Physical Therapy
Pelvic floor muscle physical therapy 5/week for 6 weeks.
|
Pelvic floor muscle physiotherapy 5x/week for 6-weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Through study completion, an average of 8 months
|
|
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.
|
Through study completion, an average of 8 months
|
|
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.
|
Through study completion, an average of 8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
International Index of Erectile Function (IIEF) Questionnaire
Time Frame: 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.
|
Through study completion, an average of 8 months
|
|
Incontinence Quality of Life Questionnaire (I-QoL)
Time Frame: 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.
|
Through study completion, an average of 8 months
|
|
Neurogenic Bladder Symptoms Score (NBSS)
Time Frame: 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.
|
Through study completion, an average of 8 months
|
|
Timed Bowel Routine
Time Frame: 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.).
|
Through study completion, an average of 8 months
|
|
Neurogenic Bowel Dysfunction Score (NBDS)
Time Frame: 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.
|
Through study completion, an average of 8 months
|
|
Female Sexual Function Index (FSFI) Questionnaire
Time Frame: 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.
|
Through study completion, an average of 8 months
|
|
Sexual Quality of Life Questionnaire - Male/Female (SQoL)
Time Frame: 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.
|
Through study completion, an average of 8 months
|
|
S4/5 Questionnaire
Time Frame: 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.
|
Through study completion, an average of 8 months
|
|
Pelvic Floor Electromyography
Time Frame: 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.
|
From enrollment to the end of treatment at 6-weeks, or discharge from inpatient care
|
|
Ultrasound Assessment
Time Frame: 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.
|
From enrollment to the end of treatment at 6-weeks, or discharge from inpatient care
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H26-00445
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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