Urinary IncontinenceNCT00178191
Randomized Trial for Botox Urinary Incontinence
A study testing Bladder diary, Questionnaires and Urodynamics in people with Urinary Incontinence, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Bladder diary, Questionnaires and Urodynamics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jul 2008
- Phase
- Interventional
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Children (< 21 years old), pregnant women and prisoners
- History of carcinoma of the bladder
- Absence of a measurable detrusor contraction on a pressure flow micturition study
- A foreign body in the bladder or other correctable etiology for the UUI
- Prior documented resistance to Botox
- Gross fecal incontinence (due to confounding effects on pad weights and counts)
Show all 10Show fewer
- Known allergy to lidocaine or related compounds (used for local analgesia)
- Known allergy to or inability to take both Bactrim DS or Ciprofloxacin (used for urinary tract infection prophylaxis)
- Current use of an aminoglycoside or preparing for general anesthesia within 1 week (risk of synergetic effects
- Known neurologic conditions such as Parkinson's disease, myasthenia gravis, multiple sclerosis, autonomic dysfunction, Lambert-Eaton syndrome, Amyotrophic Lateral Sclerosis or other neurologic disorder that may impact urinary function or the effect of Botox.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Botox for Severe Urge Incontinence
The purpose of this study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.
Read the detailed description
The prevalence of urinary incontinence in the US ranges from 3-14% with epidemiologic estimates ranging widely.1 Most urinary incontinence can be categorized into stress urinary incontinence (SUI) or UUI with UUI remaining more common and debilitating than SUI.2 A major cause of UUI is overactive bladder or detrusor instability (DI), and while DI is very common, its etiology remains unknown. DI is often successfully managed with behavioral therapy, physical therapy, medications and surgery with the most effective therapy being anticholinergic medication.2 However, side effects including dry mouth, and constipation often lead to discontinuation of these drugs. In addition, many patients fail anticholinergic medication and have persistent urinary leakage. Women who fail these treatments have limited options.
- Conditions
- Urinary Incontinence
- Being tested
- Bladder diary, Questionnaires, Urodynamics, Pad weight
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder diaryOther
3-day bladder diary
QuestionnairesOther
Incontinence Quality of Life questionnaires
UrodynamicsProcedure or surgery
Urodynamics
Pad weightOther
Pad weight
| Study group | Role | What they receive |
|---|---|---|
| 200 units Botox | Experimental | 200 units Botulinum-A toxin Receives: Other: Bladder diary; Other: Questionnaires; Procedure: Urodynamics; Other: Pad weight |
| 300 units Botox | Experimental | 300 units Botulinum-A toxin Receives: Other: Bladder diary; Other: Questionnaires; Procedure: Urodynamics; Other: Pad weight |
| Placebo | Placebo comparator | Placebo Receives: Other: Bladder diary; Other: Questionnaires; Procedure: Urodynamics; Other: Pad weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodes/Day
number of incontinence episodes/day
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionJul 2008
- Study completionJul 2008
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 Urinary IncontinenceStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Michael Flynn, University of Rochester
- Investigators
- Michael K Flynn, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178191
- Sponsor's protocol ID
- 10466
- Other IDs
- 1R21AG025490-01
- Status last verified
- Sep 2011
- First submitted
- 12 Sep 2005
- Last updated
- 3 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Botox for Severe Urge Incontinence
- ClinicalTrials.gov ID
- NCT00178191
- Acronym / sponsor ID
- 10466
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- Jun 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 3 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.
Detailed description
The prevalence of urinary incontinence in the US ranges from 3-14% with epidemiologic estimates ranging widely.1 Most urinary incontinence can be categorized into stress urinary incontinence (SUI) or UUI with UUI remaining more common and debilitating than SUI.2 A major cause of UUI is overactive bladder or detrusor instability (DI), and while DI is very common, its etiology remains unknown. DI is often successfully managed with behavioral therapy, physical therapy, medications and surgery with the most effective therapy being anticholinergic medication.2 However, side effects including dry mouth, and constipation often lead to discontinuation of these drugs. In addition, many patients fail anticholinergic medication and have persistent urinary leakage. Women who fail these treatments have limited options.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 200 units Botox | Experimental | Other: Bladder diary, Other: Questionnaires, Procedure: Urodynamics, Other: Pad weight200 units Botulinum-A toxin |
| 300 units Botox | Experimental | Other: Bladder diary, Other: Questionnaires, Procedure: Urodynamics, Other: Pad weight300 units Botulinum-A toxin |
| Placebo | Placebo comparator | Other: Bladder diary, Other: Questionnaires, Procedure: Urodynamics, Other: Pad weightPlacebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Children (< 21 years old), pregnant women and prisoners
- History of carcinoma of the bladder
- Absence of a measurable detrusor contraction on a pressure flow micturition study
- A foreign body in the bladder or other correctable etiology for the UUI
- Prior documented resistance to Botox
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 |
|---|---|---|
| Bladder diary3-day bladder diary | Other | 200 units Botox, 300 units Botox, Placebo |
| QuestionnairesIncontinence Quality of Life questionnaires | Other | 200 units Botox, 300 units Botox, Placebo |
| UrodynamicsUrodynamics | Procedure or surgery | 200 units Botox, 300 units Botox, Placebo |
| Pad weightPad weight | Other | 200 units Botox, 300 units Botox, Placebo |
Primary outcome
Episodes/Day
Time frame: 9 months
number of incontinence episodes/day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael K Flynn, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder diary, Questionnaires and Urodynamics in people with Urinary Incontinence, run by University of Rochester 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 0 inclusion and 10 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 3 Oct 2011. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2009). 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?
Episodes/Day (time frame: 9 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 3 Oct 2011.