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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
ClinicalTrials.gov Identifier:
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
June 22, 2010
October 14, 2010
October 12, 2017
June 2009
June 2011   (Final data collection date for primary outcome measure)
The primary efficacy Parameter is frequency of micturition (3-day voiding diary) [ Time Frame: Treatment Day 270 ]
Same as current
No Changes Posted
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Botox for the Treatment of Overactive Bladder Secondary to Benign Prostatic Obstruction
Randomized Double-blind Placebo Controlled Trial of Intradetrusor Injections of Botox for the Treatment of Refractory Overactive Bladder Secondary to Benign Prostatic Obstruction-BTX0621

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.

Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Overactive Bladder
Drug: Botox/Placebo
Botox/Placebo injection
  • Active Comparator: Botox
    Botox 200U
    Intervention: Drug: Botox/Placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: Botox/Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
Not Provided
June 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
40 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Dr. Alexis Te, Weill Cornell Medical College
Weill Medical College of Cornell University
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Weill Medical College of Cornell University
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP