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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Alison Williams contact

604-675-8815

alison.williams@ubc.ca

Canada1 site, 1 recruiting
  • Blusson Spinal Cord Centre

    Vancouver, British Columbia, V5Z1M9

    Alison Williams, 604-675-8815, alison.williams@ubc.ca

    Recruiting

Other trials in Canada

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:

  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.

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 groups in NCT06705790
Study groupRoleWhat they receive
Pelvic Floor Muscle Training GroupExperimentalNot described
Receives: Behavioral: Pelvic Floor Muscle Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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

  3. Feasibility - Adverse Events

    Any adverse events to study protocols will be recorded.

    Measured: Through study completion, up to 12 weeks

  4. 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)
  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 behavior, psychosocial impact, and social embarrassment.

    Measured: From enrollment to within 2 weeks of completing the study intervention

  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.

    Measured: From enrollment to within 2 weeks of completing the study intervention

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  1. First posted26 Nov 2024
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

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)
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

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.

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