Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA Treatment of Overactive Bladder: a Randomized Controlled Trial
| Registry | NCT05519072 |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 140 (Estimated) |
| Sponsor | Atlantic Health System (Other); collaborators: Columbia University |
| Conditions | Antibiotic Prophylaxis |
| Interventions | Nitrofurantoin (Drug) |
| Dates | start 2022-08-16, primary completion 2024-08-16 (estimated), completion 2024-08-16 (estimated), first posted 2022-08-29, last updated 2024-03-27 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Antibiotic Prophylaxis All trials of Nitrofurantoin
This study aims to show that lack of antibiotic prophylaxis to those undergoing bladder Botox injections is not significantly inferior to administering prophylaxis. By proving this, the investigators aim to decrease antibiotic use in this setting to combat the growing issue of antibiotic resistance.
Participants will be randomized to antibiotic or no treatment arm. Those randomized to the treatment arm will receive oral antibiotics for 2 days pre-treatment, on the treatment day, and 2 days post-treatment. Participants will return for a follow up appointment approximately 2 weeks after treatment to assess for urinary tract infection (UTI) symptoms. They will be called again at 6 weeks for follow up.
Single-centered, randomized-controlled trial. Participants will be randomized to antibiotic or no treatment arm. All subjects will obtain a urine culture approximately 14 days before the procedure. Those randomized to the treatment arm will receive oral antibiotics at the discretion of physician in accordance to patient's allergies. Antibiotics will be administered for 2 days pre-treatment, on the treatment day, and 2 days post-treatment.
Technique and dose of Botox injection will be at the discretion of the operating physician. Participants will return for a follow up appointment approximately 2 weeks after treatment as is standard, to check a post void residual. They will be called again at 6 weeks for follow up. The investigators will assess for urinary tract infection symptoms, voiding dysfunction, and other adverse events potentially related to the prophylactic antibiotics. Urine cultures will be collected, when possible, to confirm infection for patients developing symptoms.
For the sample size calculation, the investigators assume an alpha (α) value of 0.05 and a power of 80%. The UTI rate after the bladder Botox procedure is 20% (Chapple et al) and the investigators have chosen a δ of 20%. This was chosen because it was the largest amount the investigators found acceptable to presume the no antibiotic group non-inferior. Using these calculations, 64 persons are needed per study arm. With a 10% drop out rate, a total sample size would equal 140 patients total, with 70 per arm.
If participants are found to meet inclusion criteria, they will be contacted by the study team to assess for desired participation in the study. If the patient is agreeable to participate, a phone or in person consent will be obtained and the patient will be randomized. All participants, regardless of study arm, will have a urine culture collected preoperatively, approximately 14 days before procedure. If found to have a UTI, the participants will be treated accordingly. Those in the no antibiotic treatment arm will not receive any antibiotic prophylaxis and will undergo Botox injection. Those in the treatment arm will receive oral antibiotics prescribed at discretion of physician in accordance to participant's allergies.
The primary concern is the development of adverse side effects to antibiotics. Subjects will be monitored throughout the study for these potential adverse events by screening for symptoms. If an event occurs, the PI will be notified immediately. It will also be reported to the Institutional Review Board (IRB) and to all members of the research team.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Antibiotic arm | Experimental | Drug: Nitrofurantoin | Antibiotics will be administered for 2 days pre-treatment, on the treatment day, and 2 days post-treatment. |
| No treatment arm | No intervention | No antibiotics administered. |
Sex: Female, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * Female * Age ≥ 18 * Patient undergoing bladder Botox treatment Exclusion Criteria: * Pregnant and/or breastfeeding * Contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, symptomatic urinary retention or post void residual (PVR) > 200 mL, unwillingness or inability to initiate clean intermittent catheterization (CIC) post-treatment if required. * Contraindication to oral antibiotics - hypersensitivity or allergy * Inability to take medication by mouth
| Facility | City | Country | Status |
|---|---|---|---|
| Atlantic Health | Morristown, New Jersey | United States | Recruiting |