Botox for the Treatment of Overactive Bladder Secondary to Benign Prostatic Obstruction

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: NCT01220726
Recruitment Status : Unknown
Verified October 2010 by Weill Medical College of Cornell University.
Recruitment status was:  Recruiting
First Posted : October 14, 2010
Last Update Posted : October 14, 2010
Information provided by:
Weill Medical College of Cornell University

Brief Summary:

This is a prospective, randomized, double-blind study comparing intravesical injection of BOTOX to placebo. Study subjects will be randomized (1:1 ratio) to one of the following treatment groups:

Group 1 n=20 BOTOX® 200U Group 2 n=20 Placebo BOTOX® (saline) At Visit 2 (Treatment, Day 0), subjects will receive one injection cycle of BOTOX (200U) or placebo (saline). The study duration is approximately 284 days and consists of a Screening Visit (Day -7 to -14), a Treatment/Randomization Visit (Visit 2, Day 0), and Follow-up Visits at 7, 30, 90, 180, and 270 Days. Telephone Follow-ups will be made 3 days following the injection cycle.

Subjects demonstrating an insufficient response to treatment may receive an open-label injection cycle of BOTOX (200U) at Day 90. Subjects receiving this injection will re-commence Follow-up Visits and be followed for an additional 270 days.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double-blind Placebo Controlled Trial of Intradetrusor Injections of Botox for the Treatment of Refractory Overactive Bladder Secondary to Benign Prostatic Obstruction-BTX0621
Study Start Date : June 2009
Estimated Primary Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Botox
Botox 200U
Drug: Botox/Placebo
Botox/Placebo injection

Placebo Comparator: Placebo Drug: Botox/Placebo
Botox/Placebo injection

Primary Outcome Measures :
  1. The primary efficacy Parameter is frequency of micturition (3-day voiding diary) [ Time Frame: Treatment Day 270 ]

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:   Yes

Inclusion Criteria:

  1. Male outpatients of any race, between 40 and 90 years of age.
  2. Clinical signs and symptoms of frequency (>=8 micturitions/day) and urgency (>=2 episodes/day).
  3. Urodynamic history consistent with OAB that developed in conjunction with BPO and that persists for at least 3 months post TURP or PVP, RRP or other obstruction relieving procedure.
  4. OAB inadequately controlled with anticholinergic medications, as per Investigator opinion.
  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.
  8. Able to understand the requirements of the study, including completing questionnaires and signing Informed Consent/HIPAA.

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. Known history of clinically significant cardiovascular disease, cerebrovascular disease, or arrhythmia.
  3. History of spinal cord injury or multiple sclerosis, or other neurological disease which may be contributing to OAB.
  4. Known history of hydronephrosis.
  5. Current indwelling catheter, or removal of chronic catheter <1 month prior to study entry.
  6. Non-compliance with wash-out periods for prohibited medications/therapies (Supplement I).
  7. Evidence of Urinary Tract Infection according to local standard of care.
  8. Serum PSA of >10ng/mL.
  9. 24 hour total volume voided >3000 mL of urine. [As determined by completion of a patient bladder diary during the screening period]
  10. 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.
  11. Allergy or sensitivity to any component of BOTOX® (Section 5.2).
  12. Known uncontrolled systemic disease.
  13. Evidence of recent alcohol/drug abuse.
  14. Subjects who, in the opinion of the Investigator, have a significant condition that puts them at significant risk, may confound study results, or interfere with study participation.
  15. History of poor cooperation, non-compliance with medical treatment, or unreliability.

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): NCT01220726

United States, New York
Weill Cornell Medical Center Recruiting
New York, New York, United States, 10065
Contact: Noreen Buckley, NP    212-746-1626   
Sponsors and Collaborators
Weill Medical College of Cornell University

Responsible Party: Dr. Alexis Te, Weill Cornell Medical College Identifier: NCT01220726     History of Changes
Other Study ID Numbers: BTX0621
First Posted: October 14, 2010    Key Record Dates
Last Update Posted: October 14, 2010
Last Verified: October 2010

Keywords provided by Weill Medical College of Cornell University:

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