This is a Prospective, Randomized, Double-Blind Study Comparing Intravesical Injection of Botox® to Placebo. (BTX0621)

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. Identifier: NCT00479596
Recruitment Status : Unknown
Verified January 2007 by Urological Sciences Research Foundation.
Recruitment status was:  Recruiting
First Posted : May 28, 2007
Last Update Posted : May 30, 2007
Information provided by:
Urological Sciences Research Foundation

Brief Summary:
The current study will investigate the comparative efficacy, safety and patient satisfaction of intradetrusor injections BOTOX® injections (200U) versus placebo (saline) injections in the treatment of OAB secondary to benign prostatic obstruction (BPO).

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: Botox Phase 2 Phase 3

Detailed Description:

Overactive bladder is a common problem that follows chronic prostatic bladder outlet obstruction and is part of the benign prostatic hyperplasia syndrome (BPH) in men. Unfortunately, it does not often resolve after treatment (TURP, etc) of the obstruction from enlarged prostate gland. Patients with obstructive BPH typically commence treatment with alpha-blockers or anticholinergic agents; the former being used to treat enlarged prostate medically, and the latter to treat overactive bladder symptoms. However, as mentioned, anticholinergics cause many intolerable side effects leading to discontinuation in many patients. Furthermore this class of drug is still considered a relative contraindication in this population by some clinicians. Therefore other modalities need to be studied in these men.

Based on numerous studies in overactive bladder (OAB), we hypothesize that these patients will experience significant improvement (particularly if their symptoms of urgency and frequency) without significant side effects from intradetrusor injections of BOTOX® even though they have were refractory to systemic anticholinergics.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study of Intradetrusor Injections of Botox® for the Treatment of Urinary Incontinence Secondary to Benign Prostatic Obstruction (BTX0621)
Study Start Date : January 2007
Estimated Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Primary Outcome Measures :
  1. Safety and efficacy of BOTOX to placebo (saline) in the treatment of OAB secondary to BPO. [ Time Frame: 6 months post injection ]

Secondary Outcome Measures :
  1. Patient satisfaction to intradetrussor injection of Botox versus placebo. [ Time Frame: 6 months post injection ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male between 40 and 90 years of age.
  2. Clinical signs and symptoms of frequency and urgency
  3. Urodynamic history consistent with OAB that developed in conjunction with Benign Prostate Obstruction and that persists for at least 3 months post TURP or PVP, or other obstruction relieving procedure.
  4. OAB inadequately controlled with anticholinergic medications
  5. Qmax >12mL/s with a voided volume of >125mL.
  6. IPSS >12, with IPSS QoL >3 at study Visit 1.
  7. Willing to use clean intermittent catheterization (CIC) to empty the bladder or is willing to have an indwelling catheter, if necessary following study treatment.

Exclusion Criteria:

  1. Known history of interstitial cystitis, uninvestigated hematuria, bladder outlet obstruction due to vesical neck contracture, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis of urethral tumor, radiation cystitis, genitourinary tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia.
  2. Current indwelling catheter, or removal of chronic catheter <1 month prior to study entry.
  3. Non-compliance with wash-out periods for prohibited medications/therapies
  4. Evidence of Urinary Tract Infection according to local standard of care.
  5. History of prostate cancer.
  6. Serum PSA of >10ng/mL. [NOTE: Subjects with serum PSA concentrations >4 and <10 must have prostate cancer excluded according to the local standard of care.]
  7. 24 hour total volume voided >3000 mL of urine
  8. Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
  9. Allergy or sensitivity to any component of BOTOX®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00479596

Contact: Leonard S Marks, M.D. (310) 838-6347
Contact: Malu Macairan, M.D. (310) 838-6347

United States, California
Urological Sciences Research Foundation Recruiting
Culver City, California, United States, 90232
Contact: Malu Macairan, M.D.    310-838-6347   
Contact: Anthony Cancio    (310) 838-6347   
Principal Investigator: Leonard S Marks, M.D.         
Sponsors and Collaborators
Urological Sciences Research Foundation
Principal Investigator: Leonard S Marks, M.D. Urological Sciences Research Foundation

Additional Information: Identifier: NCT00479596     History of Changes
Other Study ID Numbers: BTX0621
First Posted: May 28, 2007    Key Record Dates
Last Update Posted: May 30, 2007
Last Verified: January 2007

Keywords provided by Urological Sciences Research Foundation:
Overactive Bladder
Refractory OAB

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents