This trial is looking to compare behavioral training and drug treatment for treating urinary symptoms in patients who have Parkinson's disease (PD). The main outcome to be measured is the improvement in urinary symptoms. This trial is recruiting in Atlanta, Birmingham, and Richmond, the U.S.
The details
PD is a progressive disease caused by loss of brain cells that make a substance called dopamine. The loss of these cells can affect certain functions the nervous system would normally carry out. Urinary function is coordinated by the nervous system. Diseases of the nervous system, such as PD, can, therefore, cause urinary problems. Common treatments for urinary symptoms include behavioral treatment such as pelvic floor muscle training (PFMT) and drug treatment. Solifenacin (Vesicare) is a common drug used for urinary symptoms. It relaxes urinary muscles.
This study compares using either PFMT or solifenacin to treat urinary symptoms in patients with PD. The main outcome to be measured is the change in urinary symptom severity over time.
Who are they looking for?
90 participants diagnosed with PD are needed for this trial. Participants should have significant urinary symptoms such as urinary urgency (sudden urge to urinate) and increased daytime and nighttime urination.
Participants should not have memory or thinking problems or depression. Patients who have previous PFMT, who have urine retention, catheter use or bloody urine will not be accepted in the study. Patients who have had cancer of the urinary or genital organs or surgery for treating urinary symptoms will also not be recruited. Participants must not have poorly controlled diabetes, kidney failure, or any unstable health conditions which may require hospitalization. Participants should not have had bladder botulinum injections in the past 12 months. Patients taking diuretics, alpha blockers, dutasteride/finasteride may enter the study if they are on a stable dose.
How will it work
All patients will be randomized to one of two groups. One group will receive PFMT and one will be given solifenacin. Both treatments will last 12 weeks. Urinary symptoms severity will be assessed by questionnaires at weeks 0, 6, and 12. The main outcome to be measured is the change in urinary symptom severity over time.
