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

NCT01220726 | Completed Phase 3 Results

• 1 other identifier: BTX0621
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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:

Conditions

Overactive Bladder

Keywords

OAB

Outcome Measures

Primary Outcomes (7)

• Urinary Frequency

  This is the measure of urinary frequency at baseline for those in the placebo and botox arms to day 270

  From Baseline to Day 270

• Urgency

  This measured the degree of urinary urgency using a 3-day voiding diary. Patients were assessed for the number of urgency episodes they had by answering yes or no.

  From Baseline to Day 270

• Quality of Life (QoL)

  Quality of Life (QoL) is from the ICIQ-QAB (international Consultation of Incontinence Overactive Bladder) Questionnaire. It is scored 25-160 and those with higher scores have higher impact on quality of life.

  From Baseline to Day 270

• International Consultation on Incontinence Questionnaire (ICIQ)

  ICIQ is a brief validated instrument that is comprehensive for the assessment of incontinence and measures frequency, severity and impact on quality of life. There are a total of 23 items. The overall score ranges from 1-84 with greater values indicating increased symptom severity. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient.

  From Baseline to Day 270

• Postvoid Residual Volume (PVR)

  Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition.

  From Baseline to Day 270

• Maximum Flow Rate (Qmax)

  Qmax is the the maximum recorded flow rate

  From Baseline to Day 270

• International Prostate Symptom Score (IPSS)

  International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic)

  From Baseline to Day 270

Study Arms (2)

Botox

ACTIVE COMPARATOR

200U onabotulinumtoxinA (botox)

Drug: Botox

Placebo

PLACEBO COMPARATOR

200U Saline

Drug: Placebo

Interventions

Botox DRUG

Botox injection

Botox

Placebo DRUG

Placebo injection

Placebo

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male outpatients of any race, between 40 and 90 years of age.
• Clinical signs and symptoms of frequency (\>=8 micturitions/day) and urgency (\>=2 episodes/day).
• 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.
• OAB inadequately controlled with anticholinergic medications, as per Investigator opinion.
• 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.
• Able to understand the requirements of the study, including completing questionnaires and signing Informed Consent/HIPAA.

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.
• Known history of clinically significant cardiovascular disease, cerebrovascular disease, or arrhythmia.
• History of spinal cord injury or multiple sclerosis, or other neurological disease which may be contributing to OAB.
• Known history of hydronephrosis.
• Current indwelling catheter, or removal of chronic catheter \<1 month prior to study entry.
• Non-compliance with wash-out periods for prohibited medications/therapies (Supplement I).
• Evidence of Urinary Tract Infection according to local standard of care.
• Serum PSA of \>10ng/mL.
• hour total volume voided \>3000 mL of urine. \[As determined by completion of a patient bladder diary during the screening period\]
• 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® (Section 5.2).
• Known uncontrolled systemic disease.
• Evidence of recent alcohol/drug abuse.
• 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.
• History of poor cooperation, non-compliance with medical treatment, or unreliability.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

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

Results Point of Contact

• Title: Dr. Alexis Te
• Organization: Weill Cornell Medical College

aet2005@med.cornell.edu

646-962-4811

Study Officials

• Alexis Te

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: October 14, 2010
• Study Start: June 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: November 13, 2012
• Last Updated: February 26, 2019
• Results First Posted: February 26, 2019

Record last verified: 2019-02

Locations

US (1)