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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Urological Sciences Research Foundation.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Allergan
Information provided by:
Urological Sciences Research Foundation
ClinicalTrials.gov Identifier:
NCT00479596
First received: May 25, 2007
Last updated: May 29, 2007
Last verified: January 2007
  Purpose

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 Intervention Phase
Overactive Bladder
Drug: Botox
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Urological Sciences Research Foundation:

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

Estimated Enrollment: 40
Study Start Date: January 2007
Estimated Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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®
  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: NCT00479596

Contacts
Contact: Leonard S Marks, M.D. (310) 838-6347 lsmarks@ucla.edu
Contact: Malu Macairan, M.D. (310) 838-6347 mmacairan@usrf.org

Locations
United States, California
Urological Sciences Research Foundation Recruiting
Culver City, California, United States, 90232
Contact: Malu Macairan, M.D.    310-838-6347    mmacairan@usrf.org   
Contact: Anthony Cancio    (310) 838-6347    acancio@usrf.org   
Principal Investigator: Leonard S Marks, M.D.         
Sponsors and Collaborators
Urological Sciences Research Foundation
Allergan
Investigators
Principal Investigator: Leonard S Marks, M.D. Urological Sciences Research Foundation
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00479596     History of Changes
Other Study ID Numbers: BTX0621
Study First Received: May 25, 2007
Last Updated: May 29, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on November 20, 2014