Overactive Bladder (OAB) is a condition involving bothersome urinary symptoms including involuntary leakage of urine. OAB affects between 7% and 27% of men, and 9% and 43% of women. However, involuntary leakage of urine this is associated with a sudden need to urinate, is more common in women. Because of these symptoms, patients experience a negative impact on their quality of life.
OAB is treated with behavior therapy and drugs, but many patients remain in poor control after trying these treatments.
The third-line treatments available today include:
- bladder pacemaker
- Botox bladder injection
- Nerve Stimulation
The bladder pacemaker involves two relatively invasive procedures.
Botox Bladder Treatment
Botox injection is a relatively new therapy involving the injection of a drug known by the name, "Botox," into the bladder. It works well on many, but it can lead to urinary tract infections and urinary retention problems.
Nerve stimulation is a device therapy that works similarly to the bladder pacemaker, but DOES NOT involve surgery. It involves the insertion of a small needle above the ankle and the sending of an electrical signal to the nerve under and near the needle.
Nerve stimulation works well on patients, but requires them to come back for repeated treatment sessions throughout their lives.
What is a Clinical Trial?
A clinical trial is a research study evaluating new ways to prevent, diagnose, or treat diseases. Clinical trials involve volunteers to help show that the therapy is safe and that it works. Trials are essential to the advancement of medicine. By participating in a trial, you may gain access to a new investigational treatment while helping others who may benefit from the findings in the future. In this trial, patients are reimbursed for travel expenses by the clinic.
As Institutional Review Board (IRB), also called an Ethics Board, reviews clinical trials. Each hospital or clinic where a clinical trial is to take place has an IRB made up of health-care professionals, patient advocates, and community leaders who review the trial for safety and participant rights and welfare. The trial discussed below has been reviewed by your clinic's authorized IRB.
Clinical Trial for Overactive Bladder
This clinical trial will test whether a device for OAB work and whether it is safe. If your doctor is suggesting that you may be a clinical trial candidate for this new OAB study, participation in the clinical trial may provide an opportunity to try the investigational device.
The trail will evaluate a small device that affects the nerve impulses know to affect the brain's control of the bladder.
Clinical Research Procedure
The therapy involves a procedure that can be done under local anesthetic to play the small device, about the size of a US nickel, in the lower leg. After replacement, the device applies a stimulation therapy. The device is intended to replicate the relevant electrical signal of nerve stimulation, but the device is implanted and the therapy is automated so that patients are not required to visit the doctor's office for every session. This trial will test whether the device is safe and whether it works for the treatment of overactive bladder.
Participating in Nerve Stimulation OAB Clinical Study
To participate in this trial in Omaha, your doctor will need to evaluate your:
- general health
- medical history
To see if you meet the criteria for the trial. It should take two visits to determine if you are a candidate for this trial. It should take two visits to determine if you are a candidate for the trail. If you meet the trial criteria, you will be provided with an "informed consent" document explaining the risks and potential benefits of this trial. Be sure to read over this information carefully.
In short summary, participation involves the implantation of a small device in your lower leg, turning the device on, keeping a urination diary, and visiting the clinic monthly for at least four months after the device is implanted. It is important to fully understand the purpose of the trial and what to expect before you decide whether or not you want to participate. You should ask the study coordinator or doctor questions that you have and know that the choice to participate is yours.
Adult Pediatric Urology in Omaha, NE
Our Clinical Research Department was developed to fulfill our mission to provide high-quality patient centered care. When existing treatments fail or significantly lower your quality of life we seek out new, safe methods that give you more options and make further advancements in the fields of urology and urogynecology.
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