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

Primary Purpose

Overactive Bladder

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Botox

Placebo

About this trial

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

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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.

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.
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.
24 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.

Sites / Locations

Weill Cornell Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Botox

Placebo

Arm Description

200U onabotulinumtoxinA (botox)

200U Saline

Outcomes

Primary Outcome Measures

Urinary Frequency

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

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.

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.

Postvoid Residual Volume (PVR)

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

Maximum Flow Rate (Qmax)

Qmax is the the maximum recorded flow rate

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT01220726

First Posted

June 22, 2010

Last Updated

February 7, 2019

Sponsor

Weill Medical College of Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT01220726

Brief Title

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

Official Title

Randomized Double-blind Placebo Controlled Trial of Intradetrusor Injections of Botox for the Treatment of Refractory Overactive Bladder Secondary to Benign Prostatic Obstruction-BTX0621

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

November 13, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee

5. Study Description

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:

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

Keywords

OAB

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Botox

Arm Type

Active Comparator

Arm Description

200U onabotulinumtoxinA (botox)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

200U Saline

Intervention Type

Drug

Intervention Name(s)

Botox

Intervention Description

Botox injection

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo injection

Primary Outcome Measure Information:

Title

Urinary Frequency

Description

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

Time Frame

From Baseline to Day 270

Title

Urgency

Description

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.

Time Frame

From Baseline to Day 270

Title

Quality of Life (QoL)

Description

Time Frame

From Baseline to Day 270

Title

International Consultation on Incontinence Questionnaire (ICIQ)

Description

Time Frame

From Baseline to Day 270

Title

Postvoid Residual Volume (PVR)

Description

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

Time Frame

From Baseline to Day 270

Title

Maximum Flow Rate (Qmax)

Description

Qmax is the the maximum recorded flow rate

Time Frame

From Baseline to Day 270

Title

International Prostate Symptom Score (IPSS)

Description

Time Frame

From Baseline to Day 270

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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. 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. 24 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexis Te

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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