Urinary IncontinencePhase 3NCT00373789
Refractory Urge Incontinence and Botox Injections
A Phase 3 study testing Botulinum Toxin A, bladder detrusor muscle injection in people with Urinary Incontinence and Detrusor Overactivity, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 8 sites in United States.
Trial summary
The purpose of this study is to see whether Botox A (injected into the bladder muscle) can improve symptoms of urge incontinence that has not improved with usual medical treatments. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Detrusor Overactivity, Urinary Urgency
- What is being tested?
- Botulinum Toxin A, bladder detrusor muscle injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2006to Dec 2007
- Phase
- Phase 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women
- Detrusor overactivity incontinence confirmed by urodynamic testing
- Symptoms refractory to standard first- and second-line treatments
- 6 or more urge incontinence episodes on 3-day bladder diary
- Normal neurological examination
Who cannot join
- Urinary retention
- Allergy to Botox (Botulinum Toxin A)
- Previous bladder treatment with Botox (Botulinum Toxin A) in the past year
- Pregnancy or planning pregnancy within next year
- Neurologic disease with impaired neurotransmission
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama
Birmingham, Alabama, 35249
University of North Carolina
Chapel Hill, North Carolina, 27599
Cleveland Clinic
Cleveland, Ohio, 44195
UT Southwestern
Dallas, Texas, 35249
USCD Medical Center
La Jolla, California, 92037
Loyola University
Maywood, Illinois, 60153
Univeristy of Utah
Salt Lake City, Utah, 84132
Kaiser Permanente
San Diego, California, 92120
About this study
The purpose of this study is to see whether Botox A (injected into the bladder muscle) can improve symptoms of urge incontinence that has not improved with usual medical treatments.
Read the detailed description
Women who suffer with urge incontinence may not get relief with usual medical treatment (such as medications or behavioral techniques). We plan to enroll women with refractory urge incontinence in centers across the US. Study participants will undergo cystoscopy (telescope look into the bladder) and injection of either Botox A or placebo. If symptoms are not adequately relieved, subjects participants will receive a second injection that is Botox A. Participants are interviewed monthly by study personnel to determine symptoms and health status.
- Being tested
- Botulinum Toxin A, bladder detrusor muscle injection, Vehicle saline as placebo
- Keywords
- Botulinum Toxin A, Urinary Incontinence, Detrusor Overactivity
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin A, bladder detrusor muscle injectionDrug
Also called Botox
200 U provided as a total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices.
Vehicle saline as placeboDrug
A total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices
| Study group | Role | What they receive |
|---|---|---|
| Botox A | Experimental | up to two injections of 200 Units of intra-detrusor Botulinum Toxin A , which must be separated by at least eight weeks and no more than 52 weeks Receives: Drug: Botulinum Toxin A, bladder detrusor muscle injection |
| Placebo | Placebo comparator | up to two injections of inactive injection (carrier saline), which must be separated by at least eight weeks and no more than 52 weeks Receives: Drug: Vehicle saline as placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrence of detrusor overactivity incontinence symptoms
To allow sufficient time for the onset of action of botulinum toxin A, the earliest outcome measurement was 60 days after injection. Failure was defined as a patient global impression of improvement (PGI-I) score of 4 or greater, the commencement of any new treatment at any time after the first injection or increased intensity of previously established treatment for DOI.
Measured: 6 months
Secondary outcomes (3)
Change in incontinence episode frequency by bladder diary
based on the 3-day bladder diary completed pre-intervention and at 4 weeks post injection. A successful within-subject outcome will be defined as >75% reduction in the frequency of urge incontinence episodes compared to the baseline frequency.
Measured: At 12 mos after first injection., but no less than 1 mo after second injection
Incontinence-related and health-related quality of life
measured by the Urinary Distress Inventory subscale of the PFDI/PFIQ, the PISQ, and SF-36 administered at 4 weeks after the initial injection and either prior to any re-treatment or at the completion of study participation, whichever is earlier.
Measured: At 12 mos after first injection, but no less than 1 mo after second injection.
Voiding dysfunction requiring catheterization
Measured: throughout 12-month study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: higher than anticipated rate of increased post-void residual in subjects who received botulinum toxin A injection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Linda Brubaker, MD, Study chair, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373789
- Sponsor's protocol ID
- PFDN 12
- Status last verified
- Oct 2010
- First submitted
- 6 Sep 2006
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brubaker L, Richter HE, Visco A, Mahajan S, Nygaard I, Braun TM, Barber MD, Menefee S, Schaffer J, Weber AM, Wei J; Pelvic Floor Disorders Network. Refractory idiopathic urge urinary incontinence and botulinum A injection. J Urol. 2008 Jul;180(1):217-22. doi: 10.1016/j.juro.2008.03.028. Epub 2008 May 21.
PubMed 18499184
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractory Urge Incontinence and Botox Injections
- ClinicalTrials.gov ID
- NCT00373789
- Acronym / sponsor ID
- PFDN 12
- Keywords
- Botulinum Toxin A, Urinary Incontinence, Detrusor Overactivity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: higher than anticipated rate of increased post-void residual in subjects who received botulinum toxin A injection
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jun 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 8 Sep 2006 (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 purpose of this study is to see whether Botox A (injected into the bladder muscle) can improve symptoms of urge incontinence that has not improved with usual medical treatments.
Detailed description
Women who suffer with urge incontinence may not get relief with usual medical treatment (such as medications or behavioral techniques). We plan to enroll women with refractory urge incontinence in centers across the US. Study participants will undergo cystoscopy (telescope look into the bladder) and injection of either Botox A or placebo. If symptoms are not adequately relieved, subjects participants will receive a second injection that is Botox A. Participants are interviewed monthly by study personnel to determine symptoms and health status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox A | Experimental | Drug: Botulinum Toxin A, bladder detrusor muscle injectionup to two injections of 200 Units of intra-detrusor Botulinum Toxin A , which must be separated by at least eight weeks and no more than 52 weeks |
| Placebo | Placebo comparator | Drug: Vehicle saline as placeboup to two injections of inactive injection (carrier saline), which must be separated by at least eight weeks and no more than 52 weeks |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult women
- Detrusor overactivity incontinence confirmed by urodynamic testing
- Symptoms refractory to standard first- and second-line treatments
- 6 or more urge incontinence episodes on 3-day bladder diary
- Normal neurological examination
Key exclusion criteria (5 listed)
- Urinary retention
- Allergy to Botox (Botulinum Toxin A)
- Previous bladder treatment with Botox (Botulinum Toxin A) in the past year
- Pregnancy or planning pregnancy within next year
- Neurologic disease with impaired neurotransmission
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 |
|---|---|---|
| Botulinum Toxin A, bladder detrusor muscle injectionAlso: Botox200 U provided as a total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices. | Drug | Botox A |
| Vehicle saline as placeboA total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices | Drug | Placebo |
Primary outcome
Time to recurrence of detrusor overactivity incontinence symptoms
Time frame: 6 months
To allow sufficient time for the onset of action of botulinum toxin A, the earliest outcome measurement was 60 days after injection. Failure was defined as a patient global impression of improvement (PGI-I) score of 4 or greater, the commencement of any new treatment at any time after the first injection or increased intensity of previously established treatment for DOI.
3 secondary outcomes
Change in incontinence episode frequency by bladder diary
Time frame: At 12 mos after first injection., but no less than 1 mo after second injection
Incontinence-related and health-related quality of life
Time frame: At 12 mos after first injection, but no less than 1 mo after second injection.
Voiding dysfunction requiring catheterization
Time frame: throughout 12-month study
Results and safety
The study was stopped early (reason given: higher than anticipated rate of increased post-void residual in subjects who received botulinum toxin A injection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2011.
- Results publication: PubMed 18499184Brubaker L, Richter HE, Visco A, Mahajan S, Nygaard I, Braun TM, Barber MD, Menefee S, Schaffer J, Weber AM, Wei J; Pelvic Floor Disorders Network. Refractory idiopathic urge urinary incontinence and botulinum A injection. J Urol. 2008 Jul;180(1):217-22. doi: 10.1016/j.juro.2008.03.028. Epub 2008 May 21.
- Website of the National Institute of Child Health and Human Development, which funds the Pelvic Floor Disorders NetworkLink 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.
Linda Brubaker, MD study chair
Loyola University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin A, bladder detrusor muscle injection in people with Urinary Incontinence and Detrusor Overactivity, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 8 sites 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
The study was stopped early (reason given: higher than anticipated rate of increased post-void residual in subjects who received botulinum toxin A injection). Results are not available in the source record.
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?
Time to recurrence of detrusor overactivity incontinence symptoms (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00373789, which also lists 1 linked publication.
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 11 Jan 2011; AzTrials last refreshed its copy on 3 Nov 2026.