Exploring the Benefits of Pelvic Floor Muscle Training on Bladder, Bowel, and Sexual Function in People With Spinal Cord Injury

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Behavioral: Pelvic Floor Muscle Training

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alison Williams; Phone Number: 604-675-8815; Email: alison.williams@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z1M9
      • Recruiting
      • Blusson Spinal Cord Centre
      • Contact: Alison Williams; Phone Number: 604-675-8815; Email: alison.williams@ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pelvic Floor Muscle Training Group	Behavioral: Pelvic Floor Muscle Training; Pelvic floor muscle training 5x/week for 12-weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - Recruitment Rate	Recruitment rate will be evaluated by number of participants approached, screened for eligibility, as well as reasons for exclusions.	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.	Through study completion, up to 12 weeks
Feasibility - Adverse Events	Any adverse events to study protocols will be recorded.	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.	Through study completion, up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	From enrollment to within 2 weeks of completing the study intervention

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Tania Lam, PhD, PT, University of British Columbia, ICORD

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Spinal Cord Injury; Bladder; Pelvic Floor Muscle Training; Sexual Health; Bowel
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: H21-02281; PTJ-166040 (Other Grant/Funding Number: Canadian Institutes of Health Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No