Clinical trial NCT06705790: Exploring the Benefits of Pelvic Floor Muscle Training on Bladder, Bowel, and Sexual Function in People with Spinal Cord Injury
Official title: Exploring the Feasibility and Urogenital Benefits of Pelvic Floor Muscle Training in Individuals with Motor-incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
Pelvic Floor Muscle Training
Bladder
Bowel
Sexual Health
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Feasibility - Recruitment Rate
timeFrame: Through study completion, up to 12 weeks
measure: Feasibility - Compliance
timeFrame: Through study completion, up to 12 weeks
measure: Feasibility - Adverse Events
timeFrame: Through study completion, up to 12 weeks
measure: Feasibility - Acceptability
timeFrame: Through study completion, up to 12 weeks
Secondary outcomes:
measure: Incontinence Quality of Life Questionnaire (I-QoL)
timeFrame: From enrollment to within 2 weeks of completing the study intervention
measure: Neurogenic Bladder Symptoms Score (NBSS)
timeFrame: From enrollment to within 2 weeks of completing the study intervention
measure: 3-Day Bladder Diary
timeFrame: From enrollment to within 2 weeks of completing the study intervention
measure: Timed Bowel Movement
timeFrame: From enrollment to within 2 weeks of completing the study intervention
measure: Neurogenic Bowel Dysfunction Score (NBDS)
timeFrame: From enrollment to within 2 weeks of completing the study intervention
measure: International Index of Erectile Function (IIEF) Questionnaire (Males only)
timeFrame: From enrollment to within 2 weeks of completing the study intervention
measure: Female Sexual Function Index (FSFI) Questionnaire (Females Only)
timeFrame: From enrollment to within 2 weeks of completing the study intervention
measure: Sexual Quality of Life Questionnaire - Male/Female
timeFrame: From enrollment to within 2 weeks of completing the study intervention
measure: Pelvic Floor Electromyography
timeFrame: From enrollment to within 2 weeks of completing the study intervention
measure: Effectiveness of Cueing
timeFrame: From enrollment to within 2 weeks of completing the study intervention
measure: Transcranial Magnetic Stimulation (TMS) Assessment
timeFrame: From enrollment to within 2 weeks of completing the study intervention
measure: Pudendal Somatosensory Evoked Potential (SEP) Assessment
timeFrame: From enrollment to within 2 weeks of completing the study intervention
measure: Transperineal Ultrasound
timeFrame: From enrollment to within 2 weeks of completing the study intervention
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Blusson Spinal Cord Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia, ICORD
name: Tania Lam, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: