An Open Label Study to Measure Efficacy of Fesoterodine (Toviaz) Post Surgery for Benign Prostatic Hyperplasia
Information source: Weill Medical College of Cornell University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bladder Outlet Obstruction
Intervention: Toviaz (Fesoterodine) (Drug)
Phase: Phase 4
Sponsored by: Weill Medical College of Cornell University
Official(s) and/or principal investigator(s):
Alexis Te, MD, Principal Investigator, Affiliation: Cornell University
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.
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
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: AUA symptom score
Secondary outcome: Uroflowmetry and post-void residual
Minimum age: 40 Years.
Maximum age: N/A.
Patients will be selected by the investigator and sub-investigator's patient population,
and physician referrals. All patients will meet the inclusion/ exclusion criteria.
1. Male ≥40 years of age
2. Clinical signs and symptoms of frequency and urgency, enlarged prostate and
urodynamic study consistent with overactive bladder.
3. IPSS >12, with IPSS QoL > 3 at screening visit.
4. Ability and willingness to correctly complete the micturition diary and all the trial
related questionnaires comply with scheduled visits and comply with trial procedures.
5. Capability of understanding and having signed the informed consent form after full
discussion of the research, nature of the treatment, and its risks and benefits.
6. Procedure to treat BOO by TURP or PVP greater than or equal to 1 month ago.
1. A known history of interstitial cystitis, uninvestigated hematuria, or bladder outlet
obstruction due to: mullerian duct cysts, urethral obstruction due to
stricture/valves/sclerosis of urethral tumor, radiation cystitis, genitourinary
tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia.
2. Evidence of Urinary Tract Infection according to local standard of care.
3. Expectation of initiating treatment during the duration of this study with - any drug
treatment for OAB, any drugs with significant anticholinergic, antispasmodic,
parasympathetic, or cholinergic agonistic effects.
4. Use of any electrostimulation within the 30 days before randomization, or the
expectation to initiate such therapy during the study.
5. Any condition which, in the opinion of the investigator, makes the patient unstable,
or with contraindications for inclusion, e. g., uncontrolled narrow-angled glaucoma,
urinary retention, preplanned prostate surgery, or gastric retention.
6. Significant hepatic or renal disease, defined as twice the upper limit of the
reference ranges regarding serum concentrations of AST, ALT, ALP, urea nitrogen, or
7. Use of any other investigational drug in the 2 months preceding visit 1.
8. History of postural hypotension or syncope in the judgement of the investigator based
on local standards of care.
9. Alcohol and/or any other drug abuse in the opinion of the investigator.
10. Medications such as erythromycin, Biaxin (Clarithromycin), Sporanox (itraconazole),
Nizoral (ketoconazole), Neoral and Sandimmune (cyclosporine), Velban (vinblastine)
11. Non-medication treatments such as bio-feedback or other bladder training exercises.
Locations and Contacts
New York Hospital, Cornell University, New York, New York 10065, United States; Recruiting
Noreen Buckley, NP, Phone: 212-746-1626, Email: email@example.com
Alexis Te, MD, Principal Investigator
Starting date: January 2010
Last updated: October 12, 2010