Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
138 participants
INTERVENTIONAL
2021-09-23
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intravesical OnabotulinumtoxinA
The treatment group will receive 100 units of BOTOX® reconstituted in 10mL of injectable preservative-free normal saline at the time of cystoscopy. An injection cystoscopy needle will be set to 3mm and used to inject 0.5mL reconstituted OnabotulinumtoxinA at each injection site, approximately 1cm apart along the posterior bladder wall, for a total of 20 injection sites (4 rows of 5 injection sites). This will be the only treatment.
OnabotulinumtoxinA 100 UNT
Intravesical injection
Placebo
Subjects randomized to the placebo group will undergo the same procedure but will only receive 10mL of injectable preservative-free normal saline. This will be the only treatment.
Injectable saline
Intravesical injection
Interventions
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OnabotulinumtoxinA 100 UNT
Intravesical injection
Injectable saline
Intravesical injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Bothersome OAB symptoms determined by a score of \>20 on the OAB-q SF
* Willingness to perform clean intermittent catheterization (CIC)
* Ability to follow study instructions and complete required follow up
Exclusion Criteria
* Intravesical Onabotulinumtoxin A within 3 months of the planned surgery date
* Total body Onabotulinumtoxin A dose of ≥ 400 Units in the 3 months prior to the scheduled surgery date.
* Inability or unwillingness to self-catheterize
* Post-void residual ≥ 200mL
* Neurogenic bladder or other neurological diseases that may cause voiding dysfunction
* Concurrent use of other pharmacological treatment for the treatment of OAB symptoms at the time of prolapse repair surgery.
* Females who are pregnant, think they may be pregnant at the start of the study, planning a pregnancy during the active treatment phase of the study, or who are unwilling or unable to use a reliable form of contraception during the active treatment phase of the study.
* Inability to speak or read English
18 Years
FEMALE
No
Sponsors
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Walter Reed National Military Medical Center
FED
Responsible Party
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Locations
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Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Walter Reed National Military M Center
Role: primary
References
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Other Identifiers
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3-2021
Identifier Type: -
Identifier Source: org_study_id