Exploring the Benefits of Pelvic Floor Muscle Training on Bladder, Bowel, and Sexual Function in People With Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pelvic Floor Muscle Training.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injury. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Exploring the Feasibility and Urogenital Benefits of Pelvic Floor Muscle Training in Individuals With Motor-incomplete Spinal Cord Injury
Overview
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.
Interventions
- Behavioral Pelvic Floor Muscle Training
Pelvic floor muscle training 5x/week for 12-weeks
Primary outcome measures
- Feasibility - Recruitment Rate [Time frame: Through study completion, up to 12 weeks]
- Feasibility - Compliance [Time frame: Through study completion, up to 12 weeks]
- Feasibility - Adverse Events [Time frame: Through study completion, up to 12 weeks]
- Feasibility - Acceptability [Time frame: Through study completion, up to 12 weeks]
Secondary outcome measures (12)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Blusson Spinal Cord Centre — Vancouver
Identifiers
NCT: NCT06705790 · H21-02281 · PTJ-166040