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

Primary Purpose

Overactive Bladder

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Botox
Sponsored by
Urological Sciences Research Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder, OAB, Refractory OAB, Botox, Bladder

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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®

Sites / Locations

  • Urological Sciences Research FoundationRecruiting

Outcomes

Primary Outcome Measures

Safety and efficacy of BOTOX to placebo (saline) in the treatment of OAB secondary to BPO.

Secondary Outcome Measures

Patient satisfaction to intradetrussor injection of Botox versus placebo.

Full Information

First Posted
May 25, 2007
Last Updated
May 29, 2007
Sponsor
Urological Sciences Research Foundation
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00479596
Brief Title
This is a Prospective, Randomized, Double-Blind Study Comparing Intravesical Injection of Botox® to Placebo.
Acronym
BTX0621
Official Title
Safety and Efficacy Study of Intradetrusor Injections of Botox® for the Treatment of Urinary Incontinence Secondary to Benign Prostatic Obstruction (BTX0621)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Urological Sciences Research Foundation
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive Bladder, OAB, Refractory OAB, Botox, Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Botox
Primary Outcome Measure Information:
Title
Safety and efficacy of BOTOX to placebo (saline) in the treatment of OAB secondary to BPO.
Time Frame
6 months post injection
Secondary Outcome Measure Information:
Title
Patient satisfaction to intradetrussor injection of Botox versus placebo.
Time Frame
6 months post injection

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male between 40 and 90 years of age. Clinical signs and symptoms of frequency and urgency 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. OAB inadequately controlled with anticholinergic medications Qmax >12mL/s with a voided volume of >125mL. IPSS >12, with IPSS QoL >3 at study Visit 1. 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: 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. Current indwelling catheter, or removal of chronic catheter <1 month prior to study entry. Non-compliance with wash-out periods for prohibited medications/therapies Evidence of Urinary Tract Infection according to local standard of care. History of prostate cancer. 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.] 24 hour total volume voided >3000 mL of urine 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. Allergy or sensitivity to any component of BOTOX®
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leonard S Marks, M.D.
Phone
(310) 838-6347
Email
lsmarks@ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Malu Macairan, M.D.
Phone
(310) 838-6347
Email
mmacairan@usrf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard S Marks, M.D.
Organizational Affiliation
Urological Sciences Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urological Sciences Research Foundation
City
Culver City
State/Province
California
ZIP/Postal Code
90232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malu Macairan, M.D.
Phone
310-838-6347
Email
mmacairan@usrf.org
First Name & Middle Initial & Last Name & Degree
Anthony Cancio
Phone
(310) 838-6347
Email
acancio@usrf.org
First Name & Middle Initial & Last Name & Degree
Leonard S Marks, M.D.

12. IPD Sharing Statement

Links:
URL
http://www.usrf.org
Description
Related Info

Learn more about this trial

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

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