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

NCT ID: NCT00479596

Last Updated: 2007-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-05-31

Brief Summary

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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

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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.

Conditions

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Overactive Bladder

Keywords

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Overactive Bladder OAB Refractory OAB Botox Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Botox

Intervention Type DRUG

Eligibility Criteria

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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®
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role collaborator

Urological Sciences Research Foundation

OTHER

Sponsor Role lead

Principal Investigators

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Leonard S Marks, M.D.

Role: PRINCIPAL_INVESTIGATOR

Urological Sciences Research Foundation

Locations

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Urological Sciences Research Foundation

Culver City, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Leonard S Marks, M.D.

Role: CONTACT

Phone: (310) 838-6347

Email: [email protected]

Malu Macairan, M.D.

Role: CONTACT

Phone: (310) 838-6347

Email: [email protected]

Facility Contacts

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Malu Macairan, M.D.

Role: primary

Anthony Cancio

Role: backup

Related Links

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http://www.usrf.org

Related Info

Other Identifiers

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BTX0621

Identifier Type: -

Identifier Source: org_study_id