Overactive BladderPhase 3NCT01220726
Botox for the Treatment of Overactive Bladder Secondary to Benign Prostatic Obstruction
A Phase 3 study testing Botox in people with Overactive Bladder, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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: Read more about this study
- Who is it for?
- Ages 40 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Botox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to 13 Nov 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical Center
New York, New York, 10065
About this study
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
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:
Read the 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.
- Conditions
- Overactive Bladder
- Being tested
- Botox, Placebo
- Keywords
- OAB
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BotoxDrug
Botox injection
PlaceboDrug
Placebo injection
| Study group | Role | What they receive |
|---|---|---|
| Botox | Active comparator | 200U onabotulinumtoxinA (botox) Receives: Drug: Botox |
| Placebo | Placebo comparator | 200U Saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Frequency
This is the measure of urinary frequency at baseline for those in the placebo and botox arms to day 270
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline to Day 270
Maximum Flow Rate (Qmax)
Qmax is the the maximum recorded flow rate
Measured: 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)
Measured: From Baseline to Day 270
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completion13 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis Te, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220726
- Sponsor's protocol ID
- BTX0621
- Status last verified
- Feb 2019
- First submitted
- 22 Jun 2010
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01220726
- Acronym / sponsor ID
- BTX0621
- Conditions
- Overactive Bladder
- Keywords
- OAB
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- 13 Nov 2012 (actual)
- First posted
- 14 Oct 2010 (estimated)
- Results
- Posted 26 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox | Active comparator | Drug: Botox200U onabotulinumtoxinA (botox) |
| Placebo | Placebo comparator | Drug: Placebo200U Saline |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BotoxBotox injection | Drug | Botox |
| PlaceboPlacebo injection | Drug | Placebo |
Primary outcome
Urinary Frequency
Time frame: From Baseline to Day 270
This is the measure of urinary frequency at baseline for those in the placebo and botox arms to day 270
Urgency
Time frame: From Baseline to Day 270
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)
Time frame: From Baseline to Day 270
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)
Time frame: From Baseline to Day 270
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)
Time frame: From Baseline to Day 270
Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition.
Maximum Flow Rate (Qmax)
Time frame: From Baseline to Day 270
Qmax is the the maximum recorded flow rate
International Prostate Symptom Score (IPSS)
Time frame: From Baseline to Day 270
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Te principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botox in people with Overactive Bladder, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Frequency (time frame: From Baseline to Day 270). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.