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

NCT00479596 | Unknown Phase 2

• 1 other identifier: BTX0621
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Overactive Bladder

Keywords

Overactive Bladder; OAB; Refractory OAB; Botox; Bladder

Outcome Measures

Primary Outcomes (1)

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

  6 months post injection

Secondary Outcomes (1)

• Patient satisfaction to intradetrussor injection of Botox versus placebo.

  6 months post injection

Interventions

Botox DRUG

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. \[NOTE: Subjects with serum PSA concentrations \>4 and \<10 must have prostate cancer excluded according to the local standard of care.\]
• 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®

Sponsors & Collaborators

• Urological Sciences Research Foundation: lead
• Allergan: collaborator

Study Sites (1)

Urological Sciences Research Foundation

Culver City, California, 90232, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Leonard S Marks, M.D.

  Urological Sciences Research Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonard S Marks, M.D.

CONTACT

(310) 838-6347; lsmarks@ucla.edu

Malu Macairan, M.D.

CONTACT

(310) 838-6347; mmacairan@usrf.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 25, 2007
• First Posted: May 28, 2007
• Study Start: January 1, 2007
• Study Completion: May 1, 2007
• Last Updated: May 30, 2007

Record last verified: 2007-01

Locations

US (1)