Overactive BladderPhase 2/3BTX0621NCT00479596
This is a Prospective, Randomized, Double-Blind Study Comparing Intravesical Injection of Botox® to Placebo.
A Phase 2/3 study testing Botox in people with Overactive Bladder, run by Urological Sciences Research Foundation at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Botox
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to May 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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.
- 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.]
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- 24 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®
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Urological Sciences Research Foundation
Culver City, California, 90232
Malu Macairan, M.D., 310-838-6347, mmacairan@usrf.org
Anthony Cancio, (310) 838-6347, acancio@usrf.org
About this study
Official title: Safety and Efficacy Study of Intradetrusor Injections of Botox® for the Treatment of Urinary Incontinence Secondary to Benign Prostatic Obstruction (BTX0621)
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).
Read the detailed description
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
- Overactive Bladder
- Being tested
- Botox
- Keywords
- Overactive Bladder, OAB, Refractory OAB, Botox, Bladder
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of BOTOX to placebo (saline) in the treatment of OAB secondary to BPO.
Measured: 6 months post injection
Secondary outcomes (1)
Patient satisfaction to intradetrussor injection of Botox versus placebo.
Measured: 6 months post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startJan 2007
- Study completionMay 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Urological Sciences Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Investigators
- Leonard S Marks, M.D., Principal investigator, Urological Sciences Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479596
- Sponsor's protocol ID
- BTX0621
- Acronym
- BTX0621
- Status last verified
- Jan 2007
- First submitted
- 25 May 2007
- Last updated
- 30 May 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Intradetrusor Injections of Botox® for the Treatment of Urinary Incontinence Secondary to Benign Prostatic Obstruction (BTX0621)
- ClinicalTrials.gov ID
- NCT00479596
- Acronym / sponsor ID
- BTX0621 / BTX0621
- Conditions
- Overactive Bladder
- Keywords
- Overactive Bladder, OAB, Refractory OAB, Botox, Bladder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Urological Sciences Research FoundationUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jan 2007
- Study completion
- May 2007 (estimated)
- First posted
- 28 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 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.
- 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.
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 |
|---|---|---|
| Botox | Drug | – |
Primary outcome
Safety and efficacy of BOTOX to placebo (saline) in the treatment of OAB secondary to BPO.
Time frame: 6 months post injection
1 secondary outcome
Patient satisfaction to intradetrussor injection of Botox versus placebo.
Time frame: 6 months post injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2007.
- Related InfoLink provided by the sponsor.
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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.
Leonard S Marks, M.D. principal investigator
Urological Sciences Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Botox in people with Overactive Bladder, run by Urological Sciences Research Foundation 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 30 May 2007. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonard S Marks, M.D. ((310) 838-6347, lsmarks@ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy of BOTOX to placebo (saline) in the treatment of OAB secondary to BPO. (time frame: 6 months post injection). 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 30 May 2007.