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Trial record 1 of 1 for:    NCT00605319
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An Open Label Study to Measure Efficacy of Fesoterodine (Toviaz) Post Surgery for Benign Prostatic Hyperplasia (Toviaz)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00605319
Recruitment Status : Completed
First Posted : January 31, 2008
Results First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE January 18, 2008
First Posted Date  ICMJE January 31, 2008
Results First Submitted Date  ICMJE March 17, 2017
Results First Posted Date  ICMJE April 10, 2018
Last Update Posted Date April 10, 2018
Study Start Date  ICMJE January 2010
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
  • IPSS Obstructive [ Time Frame: screening (Month 0), 2-months, 3-months, 7-months ]
    International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with obstructive symptoms which includes hesitancy or difficulty initiating the stream, straining to void, a reduced flow, an intermittent stream or a sensation of incomplete emptying.
  • IPSS Irritative [ Time Frame: screening (Month 0), 2-months, 3-months, 7-months ]
    International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with irritative symptoms which includes frequency, urgency, nocturia and urge incontinence
  • IPSS Nocturia [ Time Frame: screening (Month 0), 2-months, 3-months, 7-months ]
    International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with nocturia meaning individuals who wake up during sleeping hours to urinate.
  • International Prostate Symptom Score (IPSS) Quality of Life (QoL) [ Time Frame: screening (Month 0), 2-months, 3-months, 7-months ]
    IPSS Quality of Life (QoL) is one question used to assess how the patient's symptoms affect their quality of life. A score ranges from 1 to 6, with 6 being the worse outcome.
  • Maximum Flow Rate (Qmax) [ Time Frame: screening (Month 0), 2-months, 3-months, 7-months ]
    Urodynamics was used to meause maximum flow rate (Qmax) which is the maximum recorded flow rate of urinary
  • Average Flow Rate (Qavg) [ Time Frame: screening (Month 0), 2-months, 3-months, 7-months ]
    Average (mean) flow rate (Qavg) is the the volume of urine voided divided by the continuous flow time
  • Postvoid Residual Volume (PVR) [ Time Frame: screening (Month 0), 2-months, 3-months, 7-months ]
    Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition.
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2008)
AUA symptom score [ Time Frame: screening, 2, 3, 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2008)
Urrflowmetrya and post-void residual [ Time Frame: screening, 2, 3, 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open Label Study to Measure Efficacy of Fesoterodine (Toviaz) Post Surgery for Benign Prostatic Hyperplasia
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bladder Outlet Obstruction
Intervention  ICMJE Drug: Toviaz (Fesoterodine)
4mg to 8mg by mouth once daily
Other Name: Toviaz
Study Arms  ICMJE Toviaz (Fesoterodine)
Toviaz 4mg to 8mg
Intervention: Drug: Toviaz (Fesoterodine)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2018)
17
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2008)
50
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00605319
Other Study ID Numbers  ICMJE 0506007934
2005-0202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan to share data
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Alexis Te, MD Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP