Parkinson's DiseasePhase 4NCT01421719
Safety and Efficacy of botulinumA Toxin (BotoxA) for Treatment of Neurogenic Bladder of Parkinson's Disease
A Phase 4 study testing Cystoscopic injection of Botox into the urinary bladder in people with Parkinson's Disease and Neurogenic Bladder, run by Stanford University at 1 site in United States.
Trial summary
The basic nerve deficit of Parkinson's disease (PD) leads to lower urinary tract symptoms of frequency, urgency and urge urinary incontinence. Lower urinary tract symptoms tend to occur at more advanced stages of PD. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson's Disease, Neurogenic Bladder, Urinary Incontinence
- What is being tested?
- Cystoscopic injection of Botox into the urinary bladder
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jul 2011
- Phase
- Phase 4
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, 50 to 85 years of age.
- Patients diagnosed with Parkinson's disease prior to lower urinary tract symptoms.
- Documentation of low volume desire to void and/or unstable detrusor contractions with or without incontinence on cystometrogram. Voiding diary consistent with overactive bladder
- Written informed consent has been obtained.
- Ability to follow study instructions and likely to complete all required visits.
- Written authorization for Use and Release of Health and Research Study Information has been obtained.
- Subject has minimum to moderate severity/stage of disease, Hoehn and Yahr stage IV or less (or UPDRS equivalent)
- Usual and customary medications allowed
Who cannot join
- Uncontrolled clinically significant medical condition other than the condition under evaluation
- Known allergy or sensitivity to any of the components in the study medication.
- Concurrent participation in another investigational drug or device study or participation within 60 days period of time prior to study
- New anticholinergic medication. Should discontinue any anti-muscarinic medication 14 days prior to injection.
- Treatment with botulinum toxin of any serotype prior to enrollment in study (if applicable).
- Any medical condition that may put the subject at increased risk with exposure to BTX-A including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function (if applicable).
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- Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition (if applicable)
- Urinary tract infection
- Significant BPH with evidence of severe bladder trabeculation
- Greater than 50% post-void residual urine volume
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Hospital and Clinics
Stanford, California, 94305
About this study
Official title: Onabotulinum Toxin Type A (BTX-A) For Treatment of Neurogenic Overactive Bladder Due to Parkinson's Disease: Safety and Efficacy
The basic nerve deficit of Parkinson's disease (PD) leads to lower urinary tract symptoms of frequency, urgency and urge urinary incontinence. Lower urinary tract symptoms tend to occur at more advanced stages of PD. In the over-65 year old age group, where 1% of men suffer from this disease, they are also prone to development of benign prostatic hyperplasia (BPH) and consequent associated lower urinary tract dysfunction. Similarly the over 65-year age group develop spontaneous overactive bladder up to a prevalence of 30% of both men and women. The urologic disorder is exceedingly devastating in reducing the quality of life in these individuals due to the lower urinary tract symptoms and ultimate urinary incontinence in a high proportion of patients.
While attempts at pharmacologic treatment are partially satisfactory many patients are intolerant of oral drugs.
Read more
Botulinum-A neurotoxin (BTX-A) has been shown in pilot trials to be quite effective in reducing overactive bladder symptoms and is specifically beneficial for a wide-variety of neurogenic bladder causes of over activity . The treatment procedure of injecting the detrusor muscle of the bladder with BTX-A is quite simple, does not impose significant risks to the patient, and can be performed as an office urologic procedure.
This pilot clinical trial intends to demonstrate the safety and efficacy of low-dose Botox-A injections into the bladder to improve urinary symptoms in 20 patients.
Read the detailed description
This open-label pilot study will evaluate the safety and efficacy of intra-detrusor injections of botulinum-A toxin (BTX-A) in 20 male or female patients with Parkinson's disease and neurogenic overactive bladder with or without urinary incontinence, but without evidence of significant urinary retention (>25% of bladder capacity at void).
Patients will be invited to participate based upon subjective symptoms of uncontrolled lower urinary tract urgency, frequency and urinary incontinence. Only patients who have a Hoehn and Yahr Stage IV or better (or UPDRS equivalent) will be considered. Patients must have tried anti-muscarinic agents and failed to improve or were intolerant of these pharmacologic agents. Oral anti-muscarinic medications will be discontinued two weeks prior to urodynamics testing and treatment visit. At baseline urinary symptom scores will be obtained using The King's Health Questionnaire (KHQ, a validated scoring system for urinary symptoms) and the AUA Urinary Symptom Score. In addition a 3-day fluid intake and urinary outflow timed voiding diary will be submitted at the time of testing and treatment as well as follow-up visits.
After signing an informed consent and meeting all inclusion and exclusion criteria, patients will be tested with urodynamic studies to determine current lower urinary tract neurophysiologic functioning. A "free-flow" urinary flow rate and post-void residual urine volume test will be performed as well as filling cystometrogram and pressure/flow measurement. Patients with evidence of outlet obstruction (high pressure/low flow) will be excluded from the study. Only patients with a post-void residual urine volume less than or equal to 25% of the total bladder volume at void will be included. No catheters or other measurement devices will be attached to the body at the time of the initial free urinary flow and post-void urine volume measurement. A repeat pressure/flow determination will be performed during the urodynamics cystometrogram.
After qualification to proceed, patients will then be transferred to the adjoining cystoscopy suite. Pre-procedure oral sedation and analgesia will be given. Subjects will undergo cystoscopy under topical lidocaine anesthesia and undergo 25-gauge needle injections of BTX-A. BTX-A treatment for each participant will be limited to a total dose of 100 units in a minimum of 10 to 20 locations. Any patient unable to void after the procedure will receive an indwelling catheter for 24 hours. Patients will be contacted by telephone within 24-48 hours after the procedure for safety assessment. Follow-up clinic visit evaluations will occur at 1 month, 3 months, 6 months and 9 months. A 3-day voiding diary, King's Health Questionnaire, AUA Symptom Score sheet and Global Response Assessment (GRA) Questionnaire will be collected at each follow-up visit. Incontinence will be documented on this diary. Uroflowmetry and post-void residual volume will also be assessed at each follow-up visit.
- Conditions
- Parkinson's Disease, Neurogenic Bladder, Urinary Incontinence, Clostridium Botulinum Toxin Adverse Reaction
- Being tested
- Cystoscopic injection of Botox into the urinary bladder
- Keywords
- Parkinson's Disease, Neurogenic Bladder, Urinary Incontinence, botulinum toxin, cystoscopy, Effect of Other Parasympatholytics [Anticholinergics and Antimuscarinics] and Spasmolytics
- Medical subject headings
- Parkinson Disease, Urinary Bladder, Neurogenic, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cystoscopic injection of Botox into the urinary bladderDrug
Also called Botox A (Allergan, Inc)
100 U of Botox A injected transurethrally into the urinary bladder muscle and submucosa.
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin treatment | Experimental | botulinum toxin treatment Injection of Botox into urinary bladder for neurogenic symptoms. Receives: Drug: Cystoscopic injection of Botox into the urinary bladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Requiring Catheterization for Urinary Retention Secondary to Treatment.
Requirement for catheter because of urinary retention.
Measured: zero to six months
Secondary outcomes (1)
Number of Incontinence Episodes Per Day
Urinary incontinence 6 months after treatment (n=16). Data are included for participants who completed all diary entries and attended the Month 6 visit
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startFeb 2009
- Primary completionMay 2011
- Study completionJul 2011
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 Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Rodney U Anderson, Stanford University
- Investigators
- Rodney U Anderson, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421719
- Sponsor's protocol ID
- 000124
- Status last verified
- Jan 2017
- First submitted
- 19 Aug 2011
- Last updated
- 10 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onabotulinum Toxin Type A (BTX-A) For Treatment of Neurogenic Overactive Bladder Due to Parkinson's Disease: Safety and Efficacy
- ClinicalTrials.gov ID
- NCT01421719
- Acronym / sponsor ID
- 000124
- Conditions
- Parkinson's Disease, Neurogenic Bladder, Urinary Incontinence, Clostridium Botulinum Toxin Adverse Reaction
- Keywords
- Parkinson's Disease, Neurogenic Bladder, Urinary Incontinence, botulinum toxin, cystoscopy, Effect of Other Parasympatholytics [Anticholinergics and Antimuscarinics] and Spasmolytics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Feb 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 Aug 2011 (estimated)
- Results
- Posted 10 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The basic nerve deficit of Parkinson's disease (PD) leads to lower urinary tract symptoms of frequency, urgency and urge urinary incontinence. Lower urinary tract symptoms tend to occur at more advanced stages of PD. In the over-65 year old age group, where 1% of men suffer from this disease, they are also prone to development of benign prostatic hyperplasia (BPH) and consequent associated lower urinary tract dysfunction. Similarly the over 65-year age group develop spontaneous overactive bladder up to a prevalence of 30% of both men and women. The urologic disorder is exceedingly devastating in reducing the quality of life in these individuals due to the lower urinary tract symptoms and ultimate urinary incontinence in a high proportion of patients.
While attempts at pharmacologic treatment are partially satisfactory many patients are intolerant of oral drugs.
Botulinum-A neurotoxin (BTX-A) has been shown in pilot trials to be quite effective in reducing overactive bladder symptoms and is specifically beneficial for a wide-variety of neurogenic bladder causes of over activity . The treatment procedure of injecting the detrusor muscle of the bladder with BTX-A is quite simple, does not impose significant risks to the patient, and can be performed as an office urologic procedure.
This pilot clinical trial intends to demonstrate the safety and efficacy of low-dose Botox-A injections into the bladder to improve urinary symptoms in 20 patients.
Detailed description
This open-label pilot study will evaluate the safety and efficacy of intra-detrusor injections of botulinum-A toxin (BTX-A) in 20 male or female patients with Parkinson's disease and neurogenic overactive bladder with or without urinary incontinence, but without evidence of significant urinary retention (>25% of bladder capacity at void).
Patients will be invited to participate based upon subjective symptoms of uncontrolled lower urinary tract urgency, frequency and urinary incontinence. Only patients who have a Hoehn and Yahr Stage IV or better (or UPDRS equivalent) will be considered. Patients must have tried anti-muscarinic agents and failed to improve or were intolerant of these pharmacologic agents. Oral anti-muscarinic medications will be discontinued two weeks prior to urodynamics testing and treatment visit. At baseline urinary symptom scores will be obtained using The King's Health Questionnaire (KHQ, a validated scoring system for urinary symptoms) and the AUA Urinary Symptom Score. In addition a 3-day fluid intake and urinary outflow timed voiding diary will be submitted at the time of testing and treatment as well as follow-up visits.
After signing an informed consent and meeting all inclusion and exclusion criteria, patients will be tested with urodynamic studies to determine current lower urinary tract neurophysiologic functioning. A "free-flow" urinary flow rate and post-void residual urine volume test will be performed as well as filling cystometrogram and pressure/flow measurement. Patients with evidence of outlet obstruction (high pressure/low flow) will be excluded from the study. Only patients with a post-void residual urine volume less than or equal to 25% of the total bladder volume at void will be included. No catheters or other measurement devices will be attached to the body at the time of the initial free urinary flow and post-void urine volume measurement. A repeat pressure/flow determination will be performed during the urodynamics cystometrogram.
After qualification to proceed, patients will then be transferred to the adjoining cystoscopy suite. Pre-procedure oral sedation and analgesia will be given. Subjects will undergo cystoscopy under topical lidocaine anesthesia and undergo 25-gauge needle injections of BTX-A. BTX-A treatment for each participant will be limited to a total dose of 100 units in a minimum of 10 to 20 locations. Any patient unable to void after the procedure will receive an indwelling catheter for 24 hours. Patients will be contacted by telephone within 24-48 hours after the procedure for safety assessment. Follow-up clinic visit evaluations will occur at 1 month, 3 months, 6 months and 9 months. A 3-day voiding diary, King's Health Questionnaire, AUA Symptom Score sheet and Global Response Assessment (GRA) Questionnaire will be collected at each follow-up visit. Incontinence will be documented on this diary. Uroflowmetry and post-void residual volume will also be assessed at each follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin treatment | Experimental | Drug: Cystoscopic injection of Botox into the urinary bladderbotulinum toxin treatment Injection of Botox into urinary bladder for neurogenic symptoms. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects, 50 to 85 years of age.
- Patients diagnosed with Parkinson's disease prior to lower urinary tract symptoms.
- Documentation of low volume desire to void and/or unstable detrusor contractions with or without incontinence on cystometrogram. Voiding diary consistent with overactive bladder
- Written informed consent has been obtained.
- Ability to follow study instructions and likely to complete all required visits.
Key exclusion criteria (11 listed)
- Uncontrolled clinically significant medical condition other than the condition under evaluation
- Known allergy or sensitivity to any of the components in the study medication.
- Concurrent participation in another investigational drug or device study or participation within 60 days period of time prior to study
- New anticholinergic medication. Should discontinue any anti-muscarinic medication 14 days prior to injection.
- Treatment with botulinum toxin of any serotype prior to enrollment in study (if applicable).
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 |
|---|---|---|
| Cystoscopic injection of Botox into the urinary bladderAlso: Botox A (Allergan, Inc)100 U of Botox A injected transurethrally into the urinary bladder muscle and submucosa. | Drug | botulinum toxin treatment |
Primary outcome
Number of Patients Requiring Catheterization for Urinary Retention Secondary to Treatment.
Time frame: zero to six months
Requirement for catheter because of urinary retention.
1 secondary outcome
Number of Incontinence Episodes Per Day
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Rodney U Anderson, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cystoscopic injection of Botox into the urinary bladder in people with Parkinson's Disease and Neurogenic Bladder, run by Stanford 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 11 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 10 Mar 2017. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 10 Mar 2017). 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?
Number of Patients Requiring Catheterization for Urinary Retention Secondary to Treatment. (time frame: zero to six months). 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 10 Mar 2017.