Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Overactive Bladder, Infectious Disease, Urology, Urinary Tract Infections |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/12/2018 |
| Start Date: | July 1, 2018 |
| End Date: | September 1, 2019 |
| Contact: | Rachel Urologic Surgery Resident, MD |
| Email: | rachel.sosland@vanderbilt.edu |
| Phone: | (615) 322-8990 |
Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection: a Non-Inferiority Trial
Injection of OnabotulinumtoxinA (BTX-A) into the bladder is a widely used treatment option
for patients with overactive bladder who have failed medical therapy. Urinary tract infection
is the most common side effect of this procedure and therefore antibiotics are given around
the time of injection in order to prevent these events. While antibiotics are commonly given
at the time of injection, the duration of these antibiotic regimens are variable. The
investigators propose a study to investigate different antibiotic protocols and their affect
on the rate of urinary tract infection after injection.
for patients with overactive bladder who have failed medical therapy. Urinary tract infection
is the most common side effect of this procedure and therefore antibiotics are given around
the time of injection in order to prevent these events. While antibiotics are commonly given
at the time of injection, the duration of these antibiotic regimens are variable. The
investigators propose a study to investigate different antibiotic protocols and their affect
on the rate of urinary tract infection after injection.
Intravesical injection of OnabotulinumtoxinA (BTX-A) is a widely practiced third line therapy
for non-neurogenic overactive bladder (OAB). However, a paucity of data exists regarding
urinary tract infections (UTI), the most common adverse event following injection. The
investigators propose a randomized, controlled cross-over trial to investigate the utility of
commonly practiced antibiotic protocols and simultaneously derive information regarding risk
factors for post-procedural UTIs and their affect on treatment efficacy.
The investigators plan to initiate a prospective, randomized non-inferiority cross-over
trial, in which a participant receives peri-procedural antibiotics exclusively at the time of
one injection, and then at a subsequent injection, completes a three-day course of
antibiotics post-operatively in addition to the peri-procedural dose. Enrollment is planned
to achieve a total of 68 participants. Participants will be evaluated at 3 weeks and 3 months
following injection to identify adverse events and treatment success. Inter-injection time
will be measured and used a surrogate for efficacy over multiple injections.
These results, in addition to filling a void in current literature regarding the increasingly
utilized treatment with BTX-A, have the potential to modify clinical practice regarding
antibiotic use and decrease rates of adverse events. The means to stratify patients based on
their specific risk of UTI may be used to facilitate antibiotic stewardship and improve
patient outcomes.
for non-neurogenic overactive bladder (OAB). However, a paucity of data exists regarding
urinary tract infections (UTI), the most common adverse event following injection. The
investigators propose a randomized, controlled cross-over trial to investigate the utility of
commonly practiced antibiotic protocols and simultaneously derive information regarding risk
factors for post-procedural UTIs and their affect on treatment efficacy.
The investigators plan to initiate a prospective, randomized non-inferiority cross-over
trial, in which a participant receives peri-procedural antibiotics exclusively at the time of
one injection, and then at a subsequent injection, completes a three-day course of
antibiotics post-operatively in addition to the peri-procedural dose. Enrollment is planned
to achieve a total of 68 participants. Participants will be evaluated at 3 weeks and 3 months
following injection to identify adverse events and treatment success. Inter-injection time
will be measured and used a surrogate for efficacy over multiple injections.
These results, in addition to filling a void in current literature regarding the increasingly
utilized treatment with BTX-A, have the potential to modify clinical practice regarding
antibiotic use and decrease rates of adverse events. The means to stratify patients based on
their specific risk of UTI may be used to facilitate antibiotic stewardship and improve
patient outcomes.
Inclusion criteria:
- ≥ 18 years of age
- Medication refractory OAB, identified per AUA guidelines
Exclusion criteria:
- Post void residual urine >150ml on two occasions
- Untreated, symptomatic UTI
- Comorbid neurological conditions, including spinal cord injury, systemic neurologic
illnesses (i.e. multiple sclerosis, Parkinson's disease) or central nervous system
disease (i.e. brain tumor, stroke)
- Prior pelvic irradiation
- Current or prior bladder malignancy
- Hematuria lacking a clinically appropriate evaluation
- Chronic indwelling or intermittent catheterization
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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