|Study Title:||Optical Monitoring of Neurologic Lower Urinary Tract Dysfunction (NLUTD) Using Near Infrared Spectroscopy (NIRS)|
|Rationale:||The traditional measures of determining muscle strength of the pelvic floor such as digital exam (gloved finger applied to the vaginal area) or using a perineometer (a small probe similar to a tampon which can detect changes in surface pressure) are subjective and not sensitive enough to detect a change in improvement in women with neurologic diseases. It is known that strengthening pelvic floor muscles (vaginal area) helps to avoid urinary incontinence. Muscle fibres require oxygen to be able to contract. In women with neurologic disease decreased sensation and or muscle weakness, make it difficult for traditional measures of muscle strength to be used. Evaluation of the amount of oxygen can be done by using near infrared spectroscopy (NIRS). This equipment has already being used to evaluate the oxygen levels in newborns, and human muscles in athletes. The optimal length duration and frequency of a pelvic floor exercise regime that can be of most benefit to women with neurological problems (such as spinal cord injury for example) is not known. For this reason, we are going to use the NIRS as it has been used in athletes, to determine a measure of muscle fitness in 30 subjects (15 with bladder symptoms due to neurologic disease and 15 healthy controls).|
This study looks at a device that uses light to determine the fitness of muscles in the body, specifically the researchers want to look at the pelvic floor muscles that help with bladder control.|
This study will measure the difference in the amount of oxygen delivered to the pelvic floor muscle fibres using NIRS. The study will look at whether exercise makes any difference in the amount of oxygen in muscle fibres of the pelvic floor by comparing women who are continent (do not have a problem with bladder control and do not have neurogenic disease) with incontinent women (do have problems with bladder control and have neurogenic disease).
The following section breaks down what you can expect at study visits. The total time commitment over the 8 weeks is roughly 5 hours and the clinic and your daily exercises will take 15 minutes.
Screening Visit (2 hours)
If you agree to participate in this study and have signed this form, you will come to Blusson Spinal Cord Centre and the study team will review your information to make sure you meet all of the criteria for the study. A speculum (similar to when you have a pap smear) that has a sensor on it will be inserted in the vagina; it is only inserted just inside the vagina to send light to the pelvic floor muscles. You will be guided by the researcher to contract and relax your pelvis muscles a specific number or times. This test takes about 20 minutes to complete.
4 Weeks (1 hour)
You will return to the Blusson Spinal Cord Centre for a one hour appointment to look at your progress. During this visit how to perform pelvic floor exercises will be reviewed with you again and demonstration of how to correctly perform the exercise will be conducted with you.
8 Weeks (2 hours)
You will return to the Blusson Spinal Cord Centre for a one hour examination to look your progress. The same tests that you had done at screening will be repeated.
How the pelvic floor muscle strength has changed after completion of the exervise program will be shared at your final visit.
We hope that the information learned from this study can be used in the future to benefit other women with urinary incontinence who have neurological disease. It is hoped that the pelvic floor muscle strengthening exercises may benefit some participants with their bladder control.
|Who can participate:||Control Group: are 19 years of age or older. do not have symptoms of urinary incontinence (loss of bladder control) do not have a history of neurogenic disease (for example a spinal cord injury) Study Group: are 19 years of age or older have symptoms of urinary incontinence (loss of bladder control) have a history of neurogenic disease (for example a spinal cord injury) for at least 1 year You may be ineligible to participate in the study if you: are a woman who has had pelvic radiotherapy are pregnant (or plan to start a pregnancy soon) have pelvic pain symptoms are a woman with indwelling catheters|
|Trial Institution:||University of British Columbia / ICORD/Blusson Spinal Cord Centre|
|Trial Investigator:||Dr. Lynn Stothers|
|Trial Funding:||Craig Neilson Foundation Grant|