Spinal Cord Injuries (SCI)NCT07519928
Exploring the Feasibility and Benefits of Implementing Pelvic Floor Muscle Training During Inpatient Rehabilitation for People With Spinal Cord Injury
A study testing Pelvic Floor Muscle Physiotherapy in people with Spinal Cord Injuries (SCI), run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Spinal Cord Injuries (SCI)
- What is being tested?
- Pelvic Floor Muscle Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
GF Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
Amrit Dhaliwal, 604-675-8815, amrit.dhaliwal@vch.ca
About this study
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.
- Conditions
- Spinal Cord Injuries (SCI)
- Being tested
- Pelvic Floor Muscle Physiotherapy
- Keywords
- Spinal Cord Injury, Physiotherapy, Physical Therapy, Pelvic Floor Muscles
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle PhysiotherapyBehavioural
Pelvic floor muscle physiotherapy 5x/week for 6-weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Muscle Physical Therapy | Experimental | Pelvic floor muscle physical therapy 5/week for 6 weeks. Receives: Behavioral: Pelvic Floor Muscle Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 8 months
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.
Measured: Through study completion, an average of 8 months
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.
Measured: Through study completion, an average of 8 months
Secondary outcomes (10)
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.
Measured: Through study completion, an average of 8 months
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.
Measured: Through study completion, an average of 8 months
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.).
Measured: Through study completion, an average of 8 months
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.
Measured: Through study completion, an average of 8 months
International Index of Erectile Function (IIEF) Questionnaire
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.
Measured: Through study completion, an average of 8 months
Female Sexual Function Index (FSFI) Questionnaire
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.
Measured: Through study completion, an average of 8 months
Sexual Quality of Life Questionnaire - Male/Female (SQoL)
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.
Measured: Through study completion, an average of 8 months
S4/5 Questionnaire
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.
Measured: Through study completion, an average of 8 months
Pelvic Floor Electromyography
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.
Measured: From enrollment to the end of treatment at 6-weeks, or discharge from inpatient care
Ultrasound Assessment
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.
Measured: From enrollment to the end of treatment at 6-weeks, or discharge from inpatient care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Tania Lam, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519928
- Sponsor's protocol ID
- H26-00445
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility and Benefits of Implementing Pelvic Floor Muscle Training During Inpatient Rehabilitation for People With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07519928
- Acronym / sponsor ID
- H26-00445
- Conditions
- Spinal Cord Injuries (SCI)
- Keywords
- Spinal Cord Injury, Physiotherapy, Physical Therapy, Pelvic Floor Muscles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Muscle Physical Therapy | Experimental | Behavioral: Pelvic Floor Muscle PhysiotherapyPelvic floor muscle physical therapy 5/week for 6 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Floor Muscle PhysiotherapyPelvic floor muscle physiotherapy 5x/week for 6-weeks. | Behavioural | Pelvic Floor Muscle Physical Therapy |
Primary outcome
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 - 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 (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.
10 secondary outcomes
Incontinence Quality of Life Questionnaire (I-QoL)
Time frame: Through study completion, an average of 8 months
Neurogenic Bladder Symptoms Score (NBSS)
Time frame: Through study completion, an average of 8 months
Timed Bowel Routine
Time frame: Through study completion, an average of 8 months
Neurogenic Bowel Dysfunction Score (NBDS)
Time frame: Through study completion, an average of 8 months
International Index of Erectile Function (IIEF) Questionnaire
Time frame: Through study completion, an average of 8 months
Female Sexual Function Index (FSFI) Questionnaire
Time frame: 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
S4/5 Questionnaire
Time frame: 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
Ultrasound Assessment
Time frame: From enrollment to the end of treatment at 6-weeks, or discharge from inpatient care
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Muscle Physiotherapy in people with Spinal Cord Injuries (SCI), run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiho Song (604-675-8815, lamlab@icord.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Recruitment Rate (time frame: Through study completion, an average of 8 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.