An Open Label Study to Measure Efficacy of Fesoterodine (Toviaz) Post Surgery for Benign Prostatic Hyperplasia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00605319
First received: January 18, 2008
Last updated: October 12, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Bladder Outlet Obstruction
Drug: Toviaz (Fesoterodine)
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • AUA symptom score [ Time Frame: screening, 3, 4, 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Uroflowmetry and post-void residual [ Time Frame: screening, 3, 4, 7 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2010
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Toviaz (Fesoterodine)
Toviaz 4mg to 8mg
Drug: Toviaz (Fesoterodine)
4mg to 8mg by mouth once daily
Other Name: Toviaz

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Patients will be selected by the investigator and sub-investigator's patient population, and physician referrals. All patients will meet the inclusion/ exclusion criteria.

Inclusion 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.

Exclusion Criteria

  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 creatinine.
  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) and miconazole.
  11. Non-medication treatments such as bio-feedback or other bladder training exercises.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605319

Locations
United States, New York
New York Hospital, Cornell University Recruiting
New York, New York, United States, 10065
Contact: Noreen Buckley, NP    212-746-1626    nob2015@med.cornell.edu   
Principal Investigator: Alexis Te, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Pfizer
Investigators
Principal Investigator: Alexis Te, MD Cornell University
  More Information

No publications provided

Responsible Party: Alexis Te, M.D., Cornell University, New York Hospital
ClinicalTrials.gov Identifier: NCT00605319     History of Changes
Other Study ID Numbers: 0506007934, 2005-0202
Study First Received: January 18, 2008
Last Updated: October 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
BPH
BOO

Additional relevant MeSH terms:
Urethral Diseases
Prostatic Hyperplasia
Urinary Bladder Neck Obstruction
Prostatic Diseases
Genital Diseases, Male
Urethral Obstruction
Urologic Diseases
Urinary Bladder Diseases
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 15, 2014