Spinal Cord InjuryNCT06705790
Exploring the Benefits of Pelvic Floor Muscle Training on Bladder, Bowel, and Sexual Function in People With Spinal Cord Injury
A study testing Pelvic Floor Muscle Training in people with Spinal Cord Injury, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Pelvic Floor Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 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 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).
- Are able to speak and understand English.
Who cannot join
- 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.
- Have any permanent metal fixtures in their head (excluding dental fillings), or pacemakers, stimulators, or implanted medication pumps.
- Have a history of seizures, are taking medications that lower the seizure threshold, or experience recurring headaches.
- Have a condition for which exercise is contraindicated.
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
Blusson Spinal Cord Centre
Vancouver, British Columbia, V5Z1M9
Alison Williams, 604-675-8815, alison.williams@ubc.ca
About this study
Official title: Exploring the Feasibility and Urogenital Benefits of Pelvic Floor Muscle Training in Individuals With Motor-incomplete Spinal Cord Injury
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:
- 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.
- 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Pelvic Floor Muscle Training
- Keywords
- Spinal Cord Injury, Pelvic Floor Muscle Training, Bladder, Bowel, Sexual Health
- 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 TrainingBehavioural
Pelvic floor muscle training 5x/week for 12-weeks
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Muscle Training Group | Experimental | Not described Receives: Behavioral: Pelvic Floor Muscle Training |
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 number of participants approached, screened for eligibility, as well as reasons for exclusions.
Measured: Through study completion, up to 12 weeks
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.
Measured: Through study completion, up to 12 weeks
Feasibility - Adverse Events
Any adverse events to study protocols will be recorded.
Measured: Through study completion, up to 12 weeks
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.
Measured: Through study completion, up to 12 weeks
Secondary outcomes (13)
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.
Measured: From enrollment to within 2 weeks of completing the study intervention
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.
Measured: From enrollment to within 2 weeks of completing the study intervention
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.
Measured: From enrollment to within 2 weeks of completing the study intervention
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).
Measured: From enrollment to within 2 weeks of completing the study intervention
Neurogenic Bowel Dysfunction Score (NBDS)
Participants will be asked to complete the NBDS which asks 11 questions to clinically assess the severity of their bowel dysfunction symptoms. Results of this questionnaire provide a score from 0 to 47, where a higher score represents more severe bowel symptoms.
Measured: From enrollment to within 2 weeks of completing the study intervention
International Index of Erectile Function (IIEF) Questionnaire (Males only)
Male participants will be asked to complete the IIEF questionnaire which askes 15 questions to clinically assess sexual health in 5 domains: erectile function (possible score of 0-30), orgasmic function (possible score of 0-10), sexual desire (possible score of 0-10), intercourse satisfaction (possible score of 0-15), overall satisfaction (possible score of 0-10). In all domains, a higher score represents more severe sexual dysfunction.
Measured: From enrollment to within 2 weeks of completing the study intervention
Female Sexual Function Index (FSFI) Questionnaire (Females Only)
Female participants will be asked to complete the FSFI questionnaire which askes 19 questions to clinically assess sexual health in 6 domains: desire (possible score of 1.2-6), arousal (possible score of 0-6), lubrication (possible score of 0-6), orgasm (possible score of 0-6), satisfaction (possible score of 0.8-6), and pain (possible score of 0-6). In all domains, a higher score represents a less sexual dysfunction.
Measured: From enrollment to within 2 weeks of completing the study intervention
Sexual Quality of Life Questionnaire - Male/Female
Male and female participants will both be asked to complete their sex-specific version of this questionnaire. This questionnaire asks respondents to rate 11 statements (male, possible score of 11-66) or 18 statements (female, possible score of 18-108) according to how much they agree or disagree with it. For both the male and female version of the questionnaire, a higher score represents better sexual quality of life.
Measured: From enrollment to within 2 weeks of completing the study intervention
Pelvic Floor Electromyography
PFM function (i.e., endurance and motor control) will be assessed using surface electromyography (EMG). Disposable surface electrodes will be placed perianally to record from the pelvic floor muscles, and other electrodes will be placed over the relevant muscles in the trunk and legs. Participants will be asked to attempt various contractions of their pelvic floor muscles including a maximal, isolated pelvic floor contraction; a sustained pelvic floor contraction to assess endurance; and a rapid contract-relaxation task to assess motor control.
Measured: From enrollment to within 2 weeks of completing the study intervention
Effectiveness of Cueing
Researchers will ask participants about their perceived effectiveness of verbal instructions and feedback strategies used in the pelvic floor muscle training sessions for facilitating voluntary activation of the pelvic floor.
Measured: From enrollment to within 2 weeks of completing the study intervention
Transcranial Magnetic Stimulation (TMS) Assessment
The investigators will assess the connection of the neural pathways between the brain and pelvic floor using transcranial magnetic stimulation (TMS). TMS will be delivered over the primary motor cortex in the brain, and motor evoked potentials (MEPs) will be recorded using surface electromyography from the pelvic floor. Participants will be instruction to maintain a sub-maximal contraction of the pelvic floor during the experiment, while TMS pulses are delivered at a variety of intensities.
Measured: From enrollment to within 2 weeks of completing the study intervention
Pudendal Somatosensory Evoked Potential (SEP) Assessment
Pudendal nerve function will be assessed through an somatosensory evoked potential (SEP) assessment. Non-painful electrical stimulations of up to 1ms in duration will be delivered to the pudendal nerve via the electrodes placed over the genitals while the investigators simultaneously use an electroencephalography (EEG) cap to record from the somatosensory cortex.
Measured: From enrollment to within 2 weeks of completing the study intervention
Transperineal Ultrasound
Pelvic floor muscle 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 taken while the participant is at rest and as they attempt PFM contractions.
Measured: From enrollment to within 2 weeks of completing the study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Jun 2026 (estimated)
- Primary completion31 Mar 2028 (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 InjuryStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tania Lam, University of British Columbia
- Investigators
- Tania Lam, PhD, PT, Principal investigator, University of British Columbia, ICORD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705790
- Sponsor's protocol ID
- H21-02281
- Other IDs
- PTJ-166040
- Status last verified
- May 2026
- First submitted
- 18 Nov 2024
- Last updated
- 8 May 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility and Urogenital Benefits of Pelvic Floor Muscle Training in Individuals With Motor-incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06705790
- Acronym / sponsor ID
- H21-02281
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Pelvic Floor Muscle Training, Bladder, Bowel, Sexual Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 26 Nov 2024 (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 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:
- 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.
- 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.
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 Training Group | Experimental | Behavioral: Pelvic Floor Muscle Training |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
- Are able to speak and understand English.
Key exclusion criteria (7 listed)
- 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.
- Have any permanent metal fixtures in their head (excluding dental fillings), or pacemakers, stimulators, or implanted medication pumps.
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 TrainingPelvic floor muscle training 5x/week for 12-weeks | Behavioural | Pelvic Floor Muscle Training Group |
Primary outcome
Feasibility - Recruitment Rate
Time frame: Through study completion, up to 12 weeks
Recruitment rate will be evaluated by number of participants approached, screened for eligibility, as well as reasons for exclusions.
Feasibility - Compliance
Time frame: Through study completion, up to 12 weeks
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
Time frame: Through study completion, up to 12 weeks
Any adverse events to study protocols will be recorded.
Feasibility - Acceptability
Time frame: Through study completion, up to 12 weeks
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.
13 secondary outcomes
Incontinence Quality of Life Questionnaire (I-QoL)
Time frame: From enrollment to within 2 weeks of completing the study intervention
Neurogenic Bladder Symptoms Score (NBSS)
Time frame: From enrollment to within 2 weeks of completing the study intervention
3-Day Bladder Diary
Time frame: From enrollment to within 2 weeks of completing the study intervention
Timed Bowel Movement
Time frame: From enrollment to within 2 weeks of completing the study intervention
Neurogenic Bowel Dysfunction Score (NBDS)
Time frame: From enrollment to within 2 weeks of completing the study intervention
International Index of Erectile Function (IIEF) Questionnaire (Males only)
Time frame: From enrollment to within 2 weeks of completing the study intervention
Female Sexual Function Index (FSFI) Questionnaire (Females Only)
Time frame: From enrollment to within 2 weeks of completing the study intervention
Sexual Quality of Life Questionnaire - Male/Female
Time frame: From enrollment to within 2 weeks of completing the study intervention
Pelvic Floor Electromyography
Time frame: From enrollment to within 2 weeks of completing the study intervention
Effectiveness of Cueing
Time frame: From enrollment to within 2 weeks of completing the study intervention
Transcranial Magnetic Stimulation (TMS) Assessment
Time frame: From enrollment to within 2 weeks of completing the study intervention
Pudendal Somatosensory Evoked Potential (SEP) Assessment
Time frame: From enrollment to within 2 weeks of completing the study intervention
Transperineal Ultrasound
Time frame: From enrollment to within 2 weeks of completing the study intervention
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 8 May 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.
Tania Lam, PhD, PT principal investigator
University of British Columbia, ICORD
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 Training in people with Spinal Cord Injury, 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 5 inclusion and 7 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 8 May 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 Alison Williams (604-675-8815, alison.williams@ubc.ca), 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, up to 12 weeks). The study lists 4 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 8 May 2026.