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

NCT ID: NCT06705790

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2027-03-31

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. 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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pelvic Floor Muscle Training Group

Group Type: EXPERIMENTAL

Pelvic Floor Muscle Training

Intervention Type: BEHAVIORAL

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

Interventions

Pelvic Floor Muscle Training

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Tania Lam

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tania Lam, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia, ICORD

Locations

Blusson Spinal Cord Centre

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Alison Williams

Role: CONTACT

alison.williams@ubc.ca

604-675-8815

Facility Contacts

Alison Williams

Role: primary

alison.williams@ubc.ca

604-675-8815

Other Identifiers

PTJ-166040

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H21-02281

Identifier Type: -

Identifier Source: org_study_id