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Detrol (Tolterodine) Post Surgery for Benign Prostatic Hyperplasia
This study is currently recruiting participants.
Verified by Weill Medical College of Cornell University, March 2008
Sponsors and Collaborators: Weill Medical College of Cornell University
Pfizer
Information provided by: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00605319
  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. The investigators hypothesize that these patients would be significantly improved with a long-acting anticholinergic agent such as Detrol LA (tolterodine).

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 tolterodine 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. The investigators propose a double blind, randomized, placebo-controlled trial to evaluate the efficacy of Detrol LA 4mg, an anticholinergic in patients that have continued symptoms of overactive bladder one month following transurethral resection of the prostate. 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. The investigators expect a total of 50 patients to be enrolled within 4 months. One arm will receive placebo, the other will receive Detrol LA 4 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 American Urological Association (AUA) symptom score questionnaire, have noninvasive uroflowmetry performed, and have a post-void residual measured by bladder scan. Using standard statistical analysis, the investigators will see if there is a difference in symptoms, post-void residual, or maximum flow rate between the two arms at 6 months. The investigators will continue in an open-label manner after six months. If the Detrol LA arm has better outcomes, the investigators will offer the placebo group Detrol LA 4mg at the six month period and continue the study to evaluate long-term efficacy, dropout rate, and complications. No dosing adjustments will be allowed for the duration of the study.


Condition Intervention Phase
Bladder Outlet Obstruction
Drug: Detrol LA (Tolterodine)
Drug: Placebo
Phase IV

Drug Information available for: Tolterodine Tolterodine tartrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Pilot Study to Measure the Efficacy and Safety of Long-Acting Tolterodine (Detrol LA) on Continued Detrusor Overactivity in Patients That Have Undergone Treatment for Bladder Outlet Obstruction

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

Primary Outcome Measures:
  • AUA symptom score [ Time Frame: screening, 2, 3, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Uroflowmetry and post-void residual [ Time Frame: screening, 2, 3, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2005
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: Active Comparator
Detrol LA 4mg (tolterodine)
Drug: Detrol LA (Tolterodine)
4mg by mouth once daily
II: Placebo Comparator
Placebo
Drug: Placebo
One tablet by mouth once daily

  Eligibility

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

Inclusion Criteria:

  • Male greater than or equal to 40 years of age.
  • Clinical signs and symptoms of frequency and urgency, enlarged prostate, and urodynamic study consistent with overactive bladder.
  • IPSS greater than 12, with IPSS QoL greater than 3 at screening visit.
  • Ability and willingness to correctly complete the micturition diary and all the trial related questionnaires comply with scheduled visits and comply with trial procedures.
  • 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.
  • Procedure to treat BOO by TURP or PVP greater than 1 month ago.

Exclusion Criteria:

  • A known history of interstitial cystitis, uninvestigated hematuria, or bladder outlet obstruction due to : vesical neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis of urethral tumor, radiation cystitis, genitourinary tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia.
  • Evidence of Urinary Tract Infection according to local standard of care.
  • 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, any drug treatment for BPH.
  • Use of any electrostimulation within the 30 days before randomization, or the expectation to initiate such therapy during the study.
  • History of prostate cancer.
  • A serum prostate-specific antigen concentration of greater than10ng/mL. Men with serum PSA concentrations of greater than 10ng/mL have to have prostate cancer excluded according to the local standard of care.
  • 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.
  • 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.
  • Use of any other investigational drug in the 2 months preceding visit 1.
  • History of postural hypotension or syncope in the judgement of the investigator based on local standards of care.
  • Alcohol and/or any other drug abuse in the opinion of the investigator.
  • Medications such as erythromycin, Biaxin (clarithromycin), Sporanox (itraconazole), Nizoral (ketoconazole), Neoral and Sandimmune (cyclosporine), Velban (vinblastine), and miconazole.
  • Non-medication treatments such as bio-feedback or other bladder training exercises.
  Contacts and Locations
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: Celeste Egan, NP     212-746-1626     cae2005@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

Responsible Party: Cornell University, New York Hospital ( Alexis Te, M.D. )
Study ID Numbers: 0506007934, 2005-0202
Study First Received: January 18, 2008
Last Updated: September 15, 2008
ClinicalTrials.gov Identifier: NCT00605319  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Hyperplasia
Cystocele
Prostatic Diseases
Urologic Diseases
Prostatic Hyperplasia
Urinary Bladder Diseases
Urinary Bladder Neck Obstruction
Genital Diseases, Male
Tolterodine

Additional relevant MeSH terms:
Muscarinic Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Urethral Obstruction
Urethral Diseases
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009