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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Weill Medical College of Cornell University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01220726
First Posted: October 14, 2010
Last Update Posted: October 12, 2017
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.
Information provided by:
Weill Medical College of Cornell University
  Purpose

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 Intervention Phase
Overactive Bladder Drug: Botox/Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

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

Estimated Enrollment: 20
Study Start Date: June 2009
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Botox
Botox 200U
Drug: Botox/Placebo
Botox/Placebo injection
Placebo Comparator: Placebo Drug: Botox/Placebo
Botox/Placebo injection

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01220726


Locations
United States, New York
Weill Cornell Medical Center Recruiting
New York, New York, United States, 10065
Contact: Noreen Buckley, NP    212-746-1626    nob2015@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
  More Information

Responsible Party: Dr. Alexis Te, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT01220726     History of Changes
Other Study ID Numbers: BTX0621
First Submitted: June 22, 2010
First Posted: October 14, 2010
Last Update Posted: October 12, 2017
Last Verified: October 2010

Keywords provided by Weill Medical College of Cornell University:
OAB

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
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