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

NCT06705790 | Recruiting

• 2 other identifiers: H21-02281PTJ-166040
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.To explore the potential effectiveness of pelvic floor muscle training on pelvic floor, bladder, bowel, and sexual function.

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury; Pelvic Floor Muscle Training; Bladder; Bowel; Sexual Health

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

• Incontinence Quality of Life Questionnaire (I-QoL)

  From enrollment to within 2 weeks of completing the study intervention

• Neurogenic Bladder Symptoms Score (NBSS)

  From enrollment to within 2 weeks of completing the study intervention

• 3-Day Bladder Diary

  From enrollment to within 2 weeks of completing the study intervention

• Timed Bowel Movement

  From enrollment to within 2 weeks of completing the study intervention

• Neurogenic Bowel Dysfunction Score (NBDS)

  From enrollment to within 2 weeks of completing the study intervention

Study Arms (1)

Pelvic Floor Muscle Training Group

EXPERIMENTAL

Behavioral: Pelvic Floor Muscle Training

Interventions

Pelvic Floor Muscle Training BEHAVIORAL

Pelvic floor muscle training 5x/week for 12-weeks

Pelvic Floor Muscle Training Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Blusson Spinal Cord Centre

Vancouver, British Columbia, V5Z1M9, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Tania Lam, PhD, PT

  University of British Columbia, ICORD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison Williams

CONTACT

604-675-8815; alison.williams@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 26, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)