This trial is looking at whether a lower number of OnabotulinumtoxinA (Botox) injections are still effective in the treatment of urinary symptoms in patients with overactive bladder (OAB). The main outcome to be measured is the number of incontinence (leaking urine) episodes per day. This study is taking place in Michigan, the United States.
The details
Overactive bladder (OAB) is a group of symptoms causing a sudden urge to urinate. It may result in urge incontinence (a sudden and strong need to urinate with urine leakage). OAB can have a negative impact on quality of life. It can occur more often in women. Medications can be taken to calm the muscles and nerves which cause OAB.
OnabotulinumtoxinA (Botox) is a medication used to relax bladder muscles and help with OAB symptoms. It is given in multiple injections (typically 10). This can affect patient tolerability and satisfaction.
This study aims to test if reduced injections will improve patients satisfaction and reduce complications like blood in urine and the occurrence of urinary tract infections. The main outcome to be measured is a change in the number of incontinence episodes per day.
Who are they looking for?
178 participants are needed for this trial. Participants should have stopped any OAB medications at least 2 weeks before study entry. Participants receiving Botox injections must have had their last treatment at least 3 months before the study.
Participants should not have a diagnosis of neurogenic bladder (bladder dysfunction caused by damaged nerves). Participants should not have a history of recurrent urinary tract infections (more than 1 in 6 months, or more than 2 in a year). Female participants should not be pregnant or planning to become pregnant during the study. Patients who received Botox with no response, those receiving percutaneous nerve stimulation (PTNS) therapy will not be recruited. Participants should not have a history of pelvic cancer or radiation.
How will it work
Patients will be divided into two groups. One group will receive 100 units of Botox into 3 injection sites throughout the bladder. The other group will receive 100 units of Botox into 10 injection sites throughout the bladder. Patients will receive one treatment with an option of repeat injections every 3 months.
Patients will be asked to record the number of urinations and incontinence episodes over 3 days in their diary. Urinary symptom severity and patient satisfaction will also be evaluated at the beginning of the study and after 3 months.
