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Recruiting NCT07519928

Exploring the Feasibility and Benefits of Implementing Pelvic Floor Muscle Training During Inpatient Rehabilitation for People With Spinal Cord Injury

No phase Interventional Spinal Cord Injuries (SCI)

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 Physiotherapy.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries (SCI). 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 →

Overview

The goal of this clinical study is to determine the feasibility and explore the potential benefits of pelvic floor muscle training during inpatient SCI rehabilitation on urinary, bowel, and sexual function and quality of life in people with SCI. The main questions it aims to answer are: 1. What is the feasibility of recruiting inpatients from SCI rehabilitation to a pelvic floor muscle training program? 2. What is the feasibility and acceptance of the implementation of a pelvic floor muscle training program in SCI inpatient rehabilitation? 3. What are the potential effects of a pelvic floor muscle training program implemented in SCI inpatient rehabilitation on bladder, bowel, and sexual function and quality of life? Participants will be asked to complete a series of assessments (questionnaires, physical assessments) before and after a 6-week intervention of pelvic floor physical therapy.

Interventions

  • Behavioral Pelvic Floor Muscle Physiotherapy
    Pelvic floor muscle physiotherapy 5x/week for 6-weeks.

Primary outcome measures

  • Feasibility - Recruitment Rate [Time frame: Through study completion, an average of 8 months]
  • Feasibility - Compliance [Time frame: Through study completion, an average of 8 months]
  • Feasibility - Acceptability (Perceived Acceptability Questionnaire) [Time frame: Through study completion, an average of 8 months]
Secondary outcome measures (10)
  • Incontinence Quality of Life Questionnaire (I-QoL) [Time frame: Through study completion, an average of 8 months]
  • Neurogenic Bladder Symptoms Score (NBSS) [Time frame: Through study completion, an average of 8 months]
  • Timed Bowel Routine [Time frame: Through study completion, an average of 8 months]
  • Neurogenic Bowel Dysfunction Score (NBDS) [Time frame: Through study completion, an average of 8 months]
  • International Index of Erectile Function (IIEF) Questionnaire [Time frame: Through study completion, an average of 8 months]
  • Female Sexual Function Index (FSFI) Questionnaire [Time frame: Through study completion, an average of 8 months]
  • Sexual Quality of Life Questionnaire - Male/Female (SQoL) [Time frame: Through study completion, an average of 8 months]
  • S4/5 Questionnaire [Time frame: Through study completion, an average of 8 months]
  • Pelvic Floor Electromyography [Time frame: From enrollment to the end of treatment at 6-weeks, or discharge from inpatient care]
  • Ultrasound Assessment [Time frame: From enrollment to the end of treatment at 6-weeks, or discharge from inpatient care]

Eligibility criteria

Inclusion criteria

  • Are at least 19 years of age.
  • Have a traumatic or non-traumatic SCI
  • Are able to perform a voluntary anal contraction
  • Present with bladder or urinary tract dysfunction from SCI
  • Are a current inpatient at GF Strong Rehabilitation Center and are expected to remain as an inpatient for at least 6 weeks after the time of consent.
  • Are able to speak and understand English.

Exclusion criteria

  • Present with symptoms of lower motor neuron injury to the sacral segments (e.g. negative anal and bulbocavernosus reflexes)
  • Present with any other condition besides SCI that impacts the pelvic floor muscles or other pelvic structures
  • Are planning to receive intra-detrusor Botox injections in the next 3 months
  • Have a brain injury or other condition that interferes with their ability to follow instructions
  • Are using a ventilator
  • Have severe and unmanaged spasticity (involuntary muscle tightness or spasms) or contractures (prolonged muscle/joint stiffness)
  • Are unable to tolerate transfers to or lie on a physical therapy table
  • Experience severe pain that interferes with their ability to participate in pelvic floor muscle training

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
  • GF Strong Rehabilitation Centre — Vancouver

Identifiers

NCT: NCT07519928 · H26-00445

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗