An Open Label Study to Measure Efficacy of Fesoterodine (Toviaz) Post Surgery for Benign Prostatic Hyperplasia (Toviaz)
Recruitment status was: Recruiting
The subjects who have symptoms of overactive bladder (many trips to the bathroom, and urgency with or without the inability to hold your urine until you get to the toilet) are invited to participate in this research study. Overactive bladder is a common sequelae of long-term bladder outlet obstruction in men. Unfortunately, it does not often resolve after treatment of the obstruction (transurethral resection of the prostate). These patients are usually started empirically on alpha-blockers or occasionally anticholinergic agents, former used to treat enlarged prostate medically, and latter, to treat overactive bladder. We hypothesize that these patients would be significantly improved with a long-acting anticholinergic agent such as long acting Fesoterodine or Toviaz.
Earlier studies have shown that anticholinergic drugs seem to have a beneficial effect on symptoms of patients with bladder outlet obstruction and overactive bladder. In addition, anticholinergic drug Toviaz is not associated with increased incidence of complication like acute urinary retention, a state where patient is unable to empty the bladder as an adverse effect of the drug.
A large proportion of our patients that are undergoing treatment for bladder outlet obstruction also have overactive bladder. We propose an open label trial to evaluate the efficacy of Toviaz (fesoterodine) 4mg to 8 mg in patients that have continued symptoms of overactive bladder one month following transurethral resection of the prostate. Toviaz is an antimuscarinic and anticholinergic agent, and is a newer formulation of Detrol. Patients with overactive bladder on urodynamic test preoperatively will be considered. If these patients continue to have symptoms at the one-month post-operative visit, they will be enrolled into the study. We expect a total of 25 patients to be enrolled within 4 months. All patients will receive Toviaz 4mg to 8 mg. The patients will be followed at 3 months post-op, 4 months post-op, and 7 months post-op. At each post-op visit, the patients will fill out an AUA symptom score questionnaire, have noninvasive uroflowmetry performed, and have a post-void residual measured by bladder scan. Using standard statistical analysis, we will see if there is a difference in symptoms, post-void residual, or maximum flow rate between baseline and 7 months post-op. We will continue the study to evaluate long-term efficacy, dropout rate, and complications. An FDA approved flexible dosing regimen will be allowed for the duration of the study.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Study to Measure the Efficacy of Fesoterodine (Toviaz) on Continued Detrusor Overactivity in Patients That Have Undergone Treatment for Bladder Outlet Obstruction|
- AUA symptom score [ Time Frame: screening, 3, 4, 7 months ] [ Designated as safety issue: No ]
- Uroflowmetry and post-void residual [ Time Frame: screening, 3, 4, 7 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Toviaz 4mg to 8mg
Drug: Toviaz (Fesoterodine)
4mg to 8mg by mouth once daily
Other Name: Toviaz
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605319
|United States, New York|
|New York Hospital, Cornell University|
|New York, New York, United States, 10065|
|Principal Investigator:||Alexis Te, MD||Cornell University|